Archive for August 21st, 2012

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HipaaCat Facilitates HIPAA Compliant Communication Amongst Doctors and Nurses

HipaaCat Facilitates HIPAA Compliant Communication Amongst Doctors and Nurses

HipaaCat Facilitates HIPAA Compliant Communication Amongst Doctors and Nurses

HipaaCat is a communication system for health care providers to share messages and photos for improved communication and transitions of care in a HIPAA compliant fashion with their mobile devices (Android and iPhone). HipaaCat Chief’s role is to establish a “service” or “team”, and grants “links” with other physicians, residents, students, and nurses to become members of the team. Associated applications are HipaaCat Resident and HipaaCat nurse. HipaaCat Resident has complete access to the information of the service, adding both photos and messages. HIPAA compliant information can be sent directly to one team member, or to all the members of the service. HipaaCat Nurse can send photos and messages to the service, but does not have access to the information from other team members. Information is automatically deleted after two weeks from the mobile devices to enhance PHI (protected health information) security. A strong password is required daily to enable the application.

Deze app heeft toegang tot:

Bedieningselementen hardware

foto’s en video’s maken

Hiermee kan de app foto’s nemen en video’s maken met de camera. De app kan op deze manier op elk gewenst moment beelden verzamelen van wat de camera ziet.

Netwerkcommunicatie

volledige internettoegang

Hiermee kan de app netwerksockets maken.

Most doctors have fully embraced smartphones and other mobile devices, however they are usually more often used for quick reference and personal communication than for practical applications within the hospital. Even just simple email-like communication is rarely routinely used due to security concerns and regulations. In the United States, HIPAA, the Health Insurance Portability and Accountability Act, mandates how sensitive health information is organized, stored, reviewed and distributed. HipaaCat is a new app for Android and iOS that enables secure, encrypted HIPAA complaint communication of text messages and images through mobile devices.

Three versions exist: Chief, Resident and Nurse. The Chief app is for the head of a team and he functions as the administrator of the group. The resident is granted access by the chief, after which he can view and send messages and images. One resident can be a member of multiple teams or different teams over time. The nurse has very limited functionality and is basically only allowed to send information to the team. Messages and images are sent in a similar way to email, and can be sent to a single person or a complete team. Push notifications warn the user when new messages have arrived.

Security and HIPAA compliance is ensured by encryption of all communication between team members. Strong passwords are enforced and need to be entered at least once a day. A HIPAA compliant server is used on the backend of the service. Messages and images older than two weeks are deleted from phone and server. Lost and stolen devices are removed from the service when reported.

There is certainly a lot of potential for an app such as this, especially in specialties such as plastic surgery or dermatology, where an image may tell a lot more than just words, but also for regular and quick communication within teams when email just is not secure enough to include the patient details. The chief and resident apps are available for $4.99, while nurses can download their app for free.

Source : https://play.google.com/store/apps/details?id=com.hipaacat.resident&hl=nl

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The Key to Implanting an Artificial Pancreas? Add a Matrix for Vascularization

The Key to Implanting an Artificial Pancreas? Add a Matrix for Vascularization

The Key to Implanting an Artificial Pancreas? Add a Matrix for Vascularization

The insulin-producing cells survive longer in the engineered tissue, and produce more insulin and other essential hormones, Levenberg and colleagues said. When they transplanted the tissue into diabetic mice, the cells began functioning well enough to lower blood sugar levels in the mice.

Transplantation of islets, the pancreatic tissue that contains hormone-producing cells, is one therapy considered for people with type 1 diabetes, who produce little or no insulin because their islets are destroyed by their own immune systems. But as with many tissue and organ transplants, donors are scarce, and there is a strong possibility that the transplantation will fail.

The well-developed blood vessel network built into the engineered tissue is key to its success, the researchers concluded. The blood vessels encourage cell-to-cell communication, by secreting growth hormones and other molecules, that significantly improve the odds that transplanted tissue will survive and function normally.

The findings confirm that the blood vessel network “provides key survival signals to pancreatic, hormone-producing cells even in the absence of blood flow,” Levenberg and colleagues concluded in their study published in the journal PLoS One.

One reason transplants fail, Levenberg said, “is that the islets are usually transplanted without any accompanying blood vessels.” Until the islets begin to connect with a person’s own vascular system, they are vulnerable to starvation.

The 3-D system developed by the Technion researchers tackled this challenge by bringing together several different cell types to form a new transplantable tissue. Using a porous plastic material as the scaffold for the new tissue, the scientists seeded the scaffold with mouse islets, tiny blood vessel cells taken from human umbilical veins, and human foreskin cells that encouraged the blood vessels to develop a tube-like structure.

“The advantages provided by this type of environment are really profound,” said Xunrong Luo, an islet transplantation specialist at the Northwestern University Feinberg School of Medicine. She noted that the number of islets used to lower blood sugar levels in the mice was nearly half the number used in a typical islet transplant.

Islets grown in these rich, multicellular environments lived three times as long on average as islets grown by themselves, Levenberg and colleagues found.

The technology “is still far from tests in humans,” Levenberg said, but she noted that she and her colleagues are beginning to test the 3-D tissue scaffolds using human instead of mouse islets.

According to Northwestern’s Luo, the 3-D model demonstrated in the study “will have important and rapid clinical implications” if the same results can be replicated with human cells. “This model system also provides a good platform to study the details and mechanisms that underlie successful transplantation.”

The Technion-Israel Institute of Technology is a major source of the innovation and brainpower that drives the Israeli economy, and a key to Israel’s renown as the world’s “Start-Up Nation.” Its three Nobel Prize winners exemplify academic excellence. Technion people, ideas and inventions make immeasurable contributions to the world including life-saving medicine, sustainable energy, computer science, water conservation and nanotechnology.

American Technion Society (ATS) donors provide critical support for the Technion—more than $1.7 billion since its inception in 1940. Based in New York City, the ATS and its network of chapters across the U.S. provide funds for scholarships, fellowships, faculty recruitment and chairs, research, buildings, laboratories, classrooms and dormitories, and more.

The mechanisms underlying early islet graft failure are not entirely clear, but are thought to involve ischemic injury due to delayed vascularization. We hypothesize that blood vessels play an active role in cell-cell communications supporting islet survival and engraftment. To test this hypothesis and to uncouple endothelial cell (EC)-generated signaling stimuli from their nutritional and gas exchange functions, we developed three dimensional (3D) endothelial vessel networks in engineered pancreatic tissues prepared from islets, fibroblasts and ECs. The tri-culture setup, seeded on highly porous biocompatible polymeric scaffolds closely mimics the natural anatomical context of pancreatic vasculature. Enhanced islet survival correlating with formation of functional tube-like endothelial vessels was demonstrated. Addition of foreskin fibroblasts to islet-endothelial cultures promoted tube-like structure formation, which further supported islet survival as well as insulin secretion. Gene expression profiles of EC growth factors, extracellular matrix (ECM), morphogenes and differentiation markers were significantly different in 2D versus 3D culture systems and were further modified upon addition of fibroblasts. Implantation of prevascularized islets into diabetic mice promoted survival, integration and function of the engrafted engineered tissue, supporting the suggested role of ECs in islet survival. These findings present potential strategies for preparation of transplantable islets with increased survival prospects.

In the quest to develop a lab-grown artificial pancreas, researchers have realized that simply implanting islets (insulin-producing pancreatic cells) into a patient isn’t very effective. The implanted cells tend to die off and the overall benefit of the procedure is negligible.

A team of Israeli scientists has been working to overcome the problem by building a network of blood vessels around the islets to help these cells interact with their new environment. The 3D vessel structure, when implanted into diabetic mice, showed a considerably higher effectiveness over simple islet transplantation. Moreover, and somewhat surprisingly, the researchers report in PLoS ONE that the vessel network “provides key survival signals to pancreatic, hormone-producing cells even in the absence of blood flow.”

From the study abstract:

The tri-culture setup, seeded on highly porous biocompatible polymeric scaffolds closely mimics the natural anatomical context of pancreatic vasculature. Enhanced islet survival correlating with formation of functional tube-like endothelial vessels was demonstrated. Addition of foreskin fibroblasts to islet-endothelial cultures promoted tube-like structure formation, which further supported islet survival as well as insulin secretion. Gene expression profiles of EC growth factors, extracellular matrix (ECM), morphogenes and differentiation markers were significantly different in 2D versus 3D culture systems and were further modified upon addition of fibroblasts. Implantation of prevascularized islets into diabetic mice promoted survival, integration and function of the engrafted engineered tissue, supporting the suggested role of ECs in islet survival. These findings present potential strategies for preparation of transplantable islets with increased survival prospects.

Source : http://www.ats.org/site/News2?page=NewsArticle&id=7567&news_iv_ctrl=1161

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Part Pliers, Part Hole-Puncher, “FastStitch” Aims to Reduce Post-Op Complications

Part Pliers, Part Hole-Puncher, “FastStitch” Aims to Reduce Post-Op Complications

Part Pliers, Part Hole-Puncher, “FastStitch” Aims to Reduce Post-Op Complications

After a surgeon stitches up a patient’s abdomen, costly complications—some life-threatening—can occur. To cut down on these postoperative problems, Johns Hopkins undergraduates have invented a disposable suturing tool to guide the placement of stitches and guard against the accidental puncture of internal organs.

The student inventors have described their device, called FastStitch, as a cross between a pliers and a hole-puncher. Although the device is still in the prototype stage, the FastStitch team has already received recognition and raised more than $80,000 this year in grant and prize money to move their project forward. Among their wins were first-place finishes in University of California, Irvine, and University of Maryland business plan competitions and in the ASME International Innovation Showcase.

The student inventors have described their FastStitch suturing device as a cross between a pliers and a hole-puncher.

The FastStitch device is needed, the students say, to improve the way up to 5 million open abdominal surgeries are conducted annually in the United States alone for treatment of cancer, liver problems and other common ailments. If incisions from those procedures are not closed properly, a patient can develop complications such as infection, herniation and evisceration, all of which require additional treatment and in some cases, more surgery. Just one of these complications—herniation, in which intestinal tissue can protrude through the abdominal wall after the muscle layer splits apart—leads to $2.5 billion in additional costs annually in follow-up treatment and medical malpractice expenses, the students said.

Addressing this problem became a biomedical engineering course assignment for eight Johns Hopkins students over the past school year. They were asked to design and test a tool that would improve the way surgeons stitch together the strongest part of the abdomen, the muscle layer called the fascia, which is located just below the patient’s skin. “Doctors who have to suture the fascial layer say it can be like pushing a needle through the leather of your shoe,” said team member Luis Hererra, a sophomore biomedical engineering major from Downey, Calif. “If the needle accidentally cuts into the bowel, it can lead to a sepsis infection that can be very dangerous.”

To help prevent this, the students designed the FastStitch needle to remain housed within the jaws of the stitching tool. “You place the fascial layer between the top and bottom arms of the device,” said Sohail Zahid, of Morris Plains, N.J., leader of the student team. “Then, as you close the arms, the spring-loaded clamp is strong enough to punch the needle through the fascial layer. When this happens, the needle moves from one arm of the tool to the other.”

The device also features a visual guide to help ensure that the stitches are placed evenly, located the proper distance away from the incision and apart from one another. This should also reduce postoperative complications, the students said. The hand-size pliers-like shape was chosen because it would feel familiar to surgeons and require less training. The prototype was constructed mostly of ABS plastic, so that the instrument can be inexpensive and discarded after one use.

The FastStitch student team members are, from left, Ang Tu, Luis Herrera, Anvesh Annadanam, Sohail Zahid, Leslie Myint, Haley Huang, Stephen Van Kooten, Daniel Peng.

“We’re developing the future of suture,” said Zahid, who earned his undergraduate degree in May and has applied to Johns Hopkins’ M.D./Ph.D. program in biomedical engineering. “We believe that if the FastStitch tool is used to close abdominal incisions, it will help in three important ways: It will help surgeons by making the closure process simpler and safer. It will help hospitals by reducing costs. And, most importantly, it will help patients by reducing post-operative complications.”

Physician Hien Nguyen, an assistant professor of surgery in the Johns Hopkins School of Medicine, served as the students’ clinical advisor during the development of FastStitch. “Just about every major operation in the chest and abdomen requires a large cut to be made through the muscle layers,” he said. “If these layers are not brought back together evenly, complications can occur. This device allows the surgeon to bring the muscle layers back together evenly, safely and quickly, and this can lead to better outcomes and fewer complications.”

Nguyen had discussed the idea for a better suture tool with the undergraduate design team in a program offered by the Department of Biomedical Engineering, which is shared by the university’s School of Medicine and its Whiting School of Engineering. The course is conducted within the Center for Bioengineering Innovation and Design.

In addition to Zahid and Herrera, the other students who have participated in the FastStitch project are Andy Tu, Daniel Peng, Stephen Van Kootyen, Leslie Myint, Anvesh Annadanam and Haley Huang. Through the Johns Hopkins Technology Transfer office, the team members have obtained preliminary patent protection for their invention. All eight students are listed as co-inventors, along with Nguyen and Johns Hopkins graduate student Adam Clark.

The students have formed a Baltimore-based company, Archon Medical Technologies, to conduct further research and development of FastStitch. The company is being supported by grant funding and by most of the prize money won in the student invention and business plan contests earlier this year. Animal testing of the device is under way, and further testing with human cadavers is expected to begin later this year.

Abdominal surgery itself is pretty invasive and comes with a number of potential complications. Many of these complications – some serious – arise as a result of poor suturing. That’s because suturing the abdominal wall requires piercing through a layer of muscle called the fascia, which doctors liken to pushing a needle through a leather shoe. Accidentally puncturing a vital organ, such as the bowel, can lead to a sepsis infection. Moreover, if an incision isn’t closed properly, patients can develop herniation and evisceration.

To address these problems, biomedical engineering students at Johns Hopkins University have developed a disposable tool they call “FastStitch”. Looking somewhat like the ends of a set of jumper cables, FastStitch is described as a cross between pliers and a hole puncher. To use it, you place the fascial layer of one side of the incision in between the top and bottom “jaws.” Next, you close the arms, which causes a spring-loaded clamp to effortlessly punch a needle located on the jaws (already threaded with surgical suture) through the fascial layer, similar to the way a hole puncher works. Because the needle is always kept between the jaws of FastStitch, there’s no risk of it puncturing vital organs. The tool also has a visual guide to ensure that sutures are placed evenly and at the proper distance from the incision and from each other.

Take a look at the video below to see how FastStitch works:

Source : http://releases.jhu.edu/2012/08/16/faststitch/

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GORE Hybrid Vascular Prosthetic Graft is Green Light

GORE Hybrid Vascular Prosthetic Graft is Green Light

GORE Hybrid Vascular Prosthetic Graft is Green Lighted in EU

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates (Gore) has received CE Mark for the GORE® Hybrid Vascular Graft. The graft is designed to expand treatment options for optimal outflow by maximizing the number of access sites available. Twelve month follow-up data for newly created access implants demonstrates a trend towards significant improvement in functional graft patency and reduction in seroma, as compared to historical graft data. Since commercialization, there have been more than 2500 successful implants of the GORE Hybrid Vascular Graft in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, and other vascular procedures.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility”

The GORE Hybrid Vascular Graft, which received FDA clearance in 2010, is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysmal, peripheral vascular and end stage renal disease. The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility,” said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA® BioActive Surface (CBAS® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

“Receiving CE Mark for the GORE Hybrid Vascular Graft demonstrates our commitment to providing physicians with innovative technology that can expand treatment options and improve patient outcomes worldwide,” said Chuck Biggerstaff, associate with the Gore Venous Access Business.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 15th consecutive year. www.goremedical.com.

Products listed may not be available in all markets. GORE® and designs are trademarks of W. L. Gore & Associates. CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. AR0383-EN1 AUGUST 2012

FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates (Gore) has received CE Mark for the GORE® Hybrid Vascular Graft. The graft is designed to expand treatment options for optimal outflow by maximizing the number of access sites available. Twelve month follow-up data for newly created access implants demonstrates a trend towards significant improvement in functional graft patency and reduction in seroma, as compared to historical graft data. Since commercialization, there have been more than 2500 successful implants of the GORE Hybrid Vascular Graft in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, and other vascular procedures.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility”

The GORE Hybrid Vascular Graft, which received FDA clearance in 2010, is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels impacted by aortic aneurysmal, peripheral vascular and end stage renal disease. The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility,” said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA® BioActive Surface (CBAS® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

“Receiving CE Mark for the GORE Hybrid Vascular Graft demonstrates our commitment to providing physicians with innovative technology that can expand treatment options and improve patient outcomes worldwide,” said Chuck Biggerstaff, associate with the Gore Venous Access Business.

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 15th consecutive year. www.goremedical.com.

Products listed may not be available in all markets. GORE® and designs are trademarks of W. L. Gore & Associates. CARMEDA® and CBAS® are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. AR0383-EN1 AUGUST 2012

W. L. Gore & Associates received CE Mark approval for its GORE Hybrid Vascular Graft in the European Union, a device for replacing or bypassing damaged vasculature due to aortic aneurysms, peripheral vascular and end stage renal disease.

GORE Hybrid Vascular Graft ePTFE vascular prosthesis GORE Hybrid Vascular Prosthetic Graft is Green Lighted in EUThe device has received FDA approval back in 2010 and has already been used in over 2500 procedures.

More about the graft from the announcement:

The device is designed to address the most common causes of graft failure; intimal hyperplasia, thrombosis, and seroma. The device simplifies access to vessels with an optional over the wire deployment method that reduces vessel injury and dissection. The GORE Hybrid Vascular Graft has been used to create new access sites in anatomical locations that would have otherwise been abandoned, preserving the amount of access sites available throughout the patient’s long-term therapy.

“The GORE Hybrid Vascular Graft, for the first time, palpably bridges the gap between traditional vascular and endovascular surgery. It is the first significant innovation in vascular grafts in years, providing tremendous versatility,” said Jean Bismuth, MD, Assistant Professor at the Methodist DeBakey Heart and Vascular Center in Houston, Texas. “The GORE Hybrid Vascular Graft allows the surgeon to create a sutureless anastomosis and displays significant potential for improving hemodynamics.”

The GORE Hybrid Vascular Graft combines several trusted Gore technologies. The expanded polytetrafluoroethylene (ePTFE) vascular prosthesis has a section reinforced with nitinol. The nitinol reinforced section is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It is the only combination graft of its kind that incorporates CARMEDA® BioActive Surface (CBAS® Surface) with covalently bonded heparin, resulting in a proven thromboresistant surface.

source : http://www.businesswire.com/news/home/20120820005056/en/Gore-Receives-CE-Mark-GORE%C2%AE-Hybrid-Vascular

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EndoStim Electric Stimulator for Managing Gastric Reflux

EndoStim Electric Stimulator for Managing Gastric Reflux

EndoStim Electric Stimulator for Managing Gastric Reflux

THE HAGUE, NETHERLANDS, (August 16, 2012) – EndoStim B.V. announced today CE Mark approval of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD).

The EndoStim system uses low energy electrical pulses to strengthen a weak or dysfunctional lower esophageal sphincter (LES) muscle which is the underlying cause of gastro-esophageal reflux disease (GERD) or acid reflux. EndoStim’s device, implanted through a minimally-invasive laparoscopic procedure, is intended to treat acid reflux and eliminate the need for daily PPI medication. In clinical trials the treatment was able to significantly reduce acid exposure and related symptoms of heartburn and regurgitation without causing any gastrointestinal side effects seen with other anti-reflux procedures.

Bevil Hogg, President and CEO of EndoStim, stated “EndoStim is very excited to offer a truly revolutionary treatment to patients with severe GERD — one that is designed to normalize esophageal function. EndoStim is working closely with leading GERD experts throughout the world to develop ‘Centers of Excellence’ offering EndoStim treatment for the millions of GERD sufferers worldwide.”

Virender K Sharma MD, Chief Medical Officer of EndoStim and Director of the Arizona Center for Digestive Health, adds “EndoStim LES stimulation therapy is a result of years of research and development with leading researchers in esophageal diseases in the US and clinical investigators in Europe and South America. EndoStim’s long-term clinical data strongly supports the efficacy and safety of its therapy in patients with severe GERD.”

Clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.

EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation. The treatment is also unique in its ability to be personalized to individual patient lifestyle, diet and preferences. According to Dr. Joel Richter, Professor of Medicine and Director of the Division of Digestive Diseases and Nutrition at the University of South Florida, “What separates EndoStim LES stimulation technology from all previous GERD technologies is its ability to correct GERD pathophysiology and normalize or improve esophageal acid exposure. Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy.”

Dr. Leonardo Rodriguez, the lead investigator for the CE Mark trial conducted in Santiago, Chile, says “I believe that EndoStim LES stimulation therapy is the ideal treatment option for patients with severe GERD who are unhappy with their medical therapy or want freedom from life-long dependence on medications. I am very impressed with the clinical results and look forward to offering EndoStim therapy to my GERD patients.”

EndoStim is continuing trials in key centers across South America, Europe, and Asia. Prof. Peter D Siersema, Professor of Medicine, Director of Gastroenterology at University Medical Center, Utrecht, The Netherlands and a principal investigator in the ongoing EndoStim international multicenter trial commented that, “We are excited to be among the first sites in Europe to offer the EndoStim LES stimulation therapy to our patients. The EndoStim technology has the potential to change the way we manage GERD. With its ability to personalize treatment to an individual patient’s condition, and with its excellent safety profile, EndoStim therapy could become the ideal option for reflux patients unsatisfied or unhappy with daily medications.”

EndoStim has begun enrolling a commercial registry study worldwide and is planning for a US study to begin in late 2013.

About Reflux Disease

Gastroesophageal reflux disease is a chronic disease that affects hundreds of millions of patients worldwide, and often requires lifelong treatment with acid blocker medications. Symptoms generally occur when the weakness in the lower esophageal sphincter muscle allows stomach contents to flow backward into the esophagus causing esophageal irritation and damage. Acid reflux causes heartburn, regurgitation and can lead to Barrett esophagus and esophageal cancer. Millions of people continue to suffer from bothersome GERD symptoms despite maximal medical therapy.

About EndoStim

EndoStim is a venture-backed medical device company based in The Hague, The Netherlands, and St. Louis, Missouri, focused on developing innovative active implantable devices. Key investors include Santé Ventures (Austin, TX), Prolog Ventures (St. Louis, MO), Voyent Partners (Brentwood, TN) and Vectis Healthcare & Life Sciences Fund II (St. Louis, MO), along with many individual investors. For more information and news about EndoStim, please visit www.endostim.com.

Innovative Therapy for Severe GERD

EndoStim therapy normalizes esophageal function through electrical stimulation

EndoStim Features:

Enhanced patient quality of life

Addresses pathophysiology of GERD

Typically eliminates need for long-term acid suppressive medication

Safe, minimally-invasive laparoscopic procedure

Easily reversible, if necessary

Wirelessly customized to patients’ changing lifestyle needs and preferences

No significant alteration in patients’ anatomy or mechanical constraints on the esophagus

The EndoStim system offers a solution for severe GERD patients. EndoStim’s technology delivers tiny electrical pulses from an Implantable Pulse Generator (IPG) through a bipolar lead implanted in the patient’s lower esophageal sphincter (LES), stimulating the LES muscle and restoring the barrier between the stomach and the esophagus.

EndoStim has obtained the CE Mark for its implantable stimulator for treating gastroesophageal reflux disease (GERD). The device is implanted through a minimally invasive laparoscopy with electronic leads stretching to the lower esophageal sphincter. Electrical signals are delivered to the weakened muscle to help it keep the esophagus closed when not in use, but letting it open up when eating or belching.

EndoStim mechanism of action EndoStim Electric Stimulator for Managing Gastric Reflux (video)The company touts the procedure’s lack of observed side effects, which it attributes to the fact that the surgery doesn’t actually alter any of the patient’s anatomy. The device has yet to receive regulatory approval in the U.S.

Clinical results from the CE study demonstrate dramatic improvement of acid reflux while allowing for normal esophageal function, such as swallowing and belching. The data indicate that 100% of patients who received EndoStim treatment for 12 months were able to stop daily PPI use and 77% achieved normalization or greater than 50% reduction in abnormal esophageal acid exposure.

EndoStim LES stimulation therapy has shown both daytime and nighttime improvement in heartburn symptoms and regurgitation. The treatment is also unique in its ability to be personalized to individual patient lifestyle, diet and preferences. According to Dr. Joel Richter, Professor of Medicine and Director of the Division of Digestive Diseases and Nutrition at the University of South Florida, “What separates EndoStim LES stimulation technology from all previous GERD technologies is its ability to correct GERD pathophysiology and normalize or improve esophageal acid exposure. Safety and lack of side effects with this technology makes it an attractive option for patients looking for alternatives to traditional medical therapy.

Read about how the EndoStim technology works, patient profile, and EndoStim implantation procedure

> View EndoStim’s clinical results

In clinical studies, EndoStim patients experienced:

Sustained improvement in LES pressure and function

Normal swallowing

Relief from nighttime symptoms

Reduction in reflux events

Reduction in esophageal acid exposure

Sustained improvement in GERD symptoms and quality of life

Source : http://www.endostim.com/international/about/endostim-in-the-news/just-doing-it-2/

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New Stem Cell Line Could Shed Light on Many Human Diseases

New Stem Cell Line Could Shed Light on Many Human Diseases

New Stem Cell Line Could Shed Light on Many Human Diseases

Researchers have generated a new type of human stem cell that can develop into numerous types of specialized cells, including functioning pancreatic beta cells that produce insulin. Called endodermal progenitor (EP) cells, the new cells show two important advantages over embryonic stem cells and induced pluripotent stem cells: they do not form tumors when transplanted into animals, and they can form functional pancreatic beta cells in the laboratory.

Powerful new tool for modeling how diseases develop

“Our cell line offers a powerful new tool for modeling how many human diseases develop,” said study leader Paul J. Gadue, PhD, a stem cell biologist in the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia. “Additionally, pancreatic beta cells generated from EP cells display better functional ability in the laboratory than beta cells derived from other stem cell populations.”

In addition to producing beta cells, the researchers also directed EP cells to develop into liver cells and intestinal cells—both of which normally develop from the endoderm tissue layer early in human development.

Gadue and colleagues are publishing their study Friday, April 6 in the journal Cell/Stem Cell.

Reprogramming human stem cells into EP cells

The researchers manipulated two types of human stem cells—embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs)—to become EP cells. Because both stem cell populations proliferate in great numbers and potentially generate all types of tissue, they offer enormous promise for scientists to precisely control cell development, both for the study of basic biology and for future cell-based treatments.

ESCs are derived from human embryos, typically unused embryos from fertility treatments that are donated for research purposes, while iPSCs are engineered from human somatic cells, such as skin cells or blood cells. Researchers have learned how to reprogram somatic cells to become pluripotent. Like ESCs, iPSCs are able to develop into many other types of human cells. However, when undifferentiated ESCs or iPSCs are transplanted in animal studies, they form teratomas, tumors containing many different cell types. Therefore, it has been critical that any cell type generated from ESCs or iPSCs and used for transplantation is stringently purified to exclude undifferentiated cells with tumor-forming potential.

In the current study, the researchers used signaling molecules called cytokines to steer ESCs and iPSCs into becoming EP cells, committed to developing into endoderm, one of the three tissue layers found in early human development. The EP cells have nearly unlimited potential for growth in the laboratory.

Benefits of EP cells

Both in cell cultures and when transplanted into animals, the study team showed that EP cells can differentiate into multiple cell types, representing those found in the liver, pancreas and intestine. Importantly, undifferentiated EP cells did not form teratomas in the team’s transplantation studies.

In cell culture, the researchers differentiated the EP cells into beta cells—insulin-expressing cells similar to those found in the pancreas. Those engineered beta cells passed an important test—when stimulated by glucose, they were able to release insulin, a function that is impaired or absent in patients with diabetes. While the cells achieved only 20 percent of normal function, this result is an improvement over that seen in similar cells derived directly from ESCs or iPSCs, which typically respond very poorly or not at all to glucose.

Future research directions

Gadue stressed that these promising early results are only the first steps in researching EP cells. Further work may focus on taking cells from individual patients with genetic forms of diabetes or liver disease to derive EP cell lines. The EP cell lines can then be used to model the development and progression of the patient’s disease and discover new therapies for that particular disease.

Finally, although applying this science to cell therapy is years away from practical clinical use, EP cells may offer a powerful starting point for developing tissue replacement treatments, such as supplying beta cells for diabetes patients or hepatocytes (liver cells) for patients with liver disease. “While more work is needed to characterize EP cells, they may offer a potential source of safe, abundant cells for future diabetes treatments,” said Gadue.

Study funding and authors

Financial support for this study came from the National Institutes of Health. Co-authors with Gadue included Deborah L. French, PhD, Xin Cheng, PhD, and Mitchell J. Weiss, MD, PhD, all of The Children’s Hospital of Philadelphia; Darrell Kotton, MD, of Boston University School of Medicine; and M. Cristina Nostro, PhD, of the McEwen Centre for Regenerative Medicine, Toronto, Canada.

A novel type of human stem cell has been developed by researchers at Children’s Hospital of Philadelphia that can develop into various specialized cells, including functioning pancreatic beta cells that produce insulin. Unlike embryonic stem cells and induced pluripotent stem cells, the endodermal progenitor (EP) cells do not form tumors when transplanted into animals. In addition, the EP cells are capable of forming functional pancreatic beta cells in the laboratory.

One potential target of future research on EP cell lines is to derive the cells from patients with genetic forms of diabetes or liver disease and then use them to model the progression of the disease, potentially developing new therapies in the process.

“Our cell line offers a powerful new tool for modeling how many human diseases develop,” explained study leader Paul J. Gadue, PhD, of the Center for Cellular and Molecular Therapeutics at The Children’s Hospital of Philadelphia in a statement. “Additionally, pancreatic beta cells generated from EP cells display better functional ability in the laboratory than beta cells derived from other stem cell populations.” Gadue acknowledges that more more work is required to characterize EP cells, but adds that the cells could offer “a potential source of safe, abundant cells for future diabetes treatments.”

The researchers also managed to coax the EP cells to turn into liver cells and intestinal cells—both of which normally develop from the endoderm tissue layer early in human development.

The scientists were able to create the cells by manipulating both embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).

A bit more from the press release:

In cell culture, the researchers differentiated the EP cells into beta cells—insulin-expressing cells similar to those found in the pancreas. Those engineered beta cells passed an important test—when stimulated by glucose, they were able to release insulin, a function that is impaired or absent in patients with diabetes. While the cells achieved only 20 percent of normal function, this result is an improvement over that seen in similar cells derived directly from ESCs or iPSCs, which typically respond very poorly or not at all to glucose.

source : http://www.chop.edu/news/stem-cell-line-safe-for-disease-modeling-and-transplant-studies.html

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DistalMotion’s Surgical Tool Combines the Best of Robotic and Endoscopic Surgery

DistalMotion’s Surgical Tool Combines the Best of Robotic and Endoscopic Surgery

DistalMotion’s Surgical Tool Combines the Best of Robotic and Endoscopic Surgery

A machine that allows highly skilled surgeons to effectively lengthen their fingers has been designed in the Robotics System Laboratory. Ricardo Beira elaborated this idea in his thesis, and subsequently created the start-up, DistalMotion, to further develop it:. The device is controlled by small joysticks which allow the operation of surgical tools fixed to the end of a metal arm. The goal? To facilitate minimally invasive operations without opening the abdominal wall.

Two to three bodily orifices allow for the passage of a small camera and long surgical instruments. This technique, known as endoscopy, is used more and more in urology, gynecology and visceral surgery.While this technique has many benefits, the main problem is the lack of precision in the surgeon’s movements, which is linked to the rigidity of the tools. Moreover, the surgeon must work with a mirror as, for example, a movement to the surgeon’s left results in the tool moving to the right; hence, a particularly intense training is necessary. Ricardo Beira’s system solves these problems.

Completely Mechanical

The small joysticks are able to exactly replicate the surgeon’s movements,. As a result, pliers, scissors, needles and other tools move as if a practitioner was directly holding them. The research completed at the robotics laboratory has allowed for the elimination of a problem inherent to such mechanisms, the exaggeration of movements. When a small movement outside of the patient’s body is translated into a larger one inside the patient, operations become even more. delicate and painstaking. Thanks to this device, seven degrees of freedom are permitted in the reproduction of movement, including, for example, the rotation of the wrist.

In the era of robotics crammed with electronics, detectors and sensors, this mechanical engine developed by Ricardo Beira is quite remarkable. It should permit a considerable expansion of the variety of coelioscopic procedures, which present numerous advantages in relation to traditional surgery, notably with regard to safety, aesthetics and cost. The post-operative pain and risk of infection are lesser, the scars are smaller, and the stay at the hospital shorter.

The device requires craftsmanship of the highest and most detailed order, but the horizon is bright due to the numerous foreseen advantages . “The future cost of production will lie outside a common measure with the only devices capable of this much mobility in this type of operation, the DaVinci robots. These enormous devices, which equip only a few hospitals in the world, cost millions and necessitate huge spaces,”explains Ricardo Beira.

Second Prototype and Pre-Clinical Trials

Pre-clinical trials at the CHUV and the Inselspital in Bern will take place this year with simulations of prostate operations. The product was redesigned to give it a more appealing form for the market. The start-up has just been created, but a few days ago it won the final phase of Venture Kick, an aid to young talents worth up to 130,000 Swiss francs. The validation process of the system is in progress.

The two new winners of venture kick are located in Lausanne and Zurich. Spin-off of EPFL, DistalMotion developing a new type of surgery, minimally invasive, for prostate cancer. The start-up UrbanFarmers Zurich defends it on a model of urban agriculture unpublished. In closing the last stage of venture kick, the two young companies will now be able to truly launch the entrepreneurial adventure thanks to 130,000 francs seed funds collected so far.

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The team DistalMotion: Ricardo Beira and Lionel Flaction

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Roman Gaus and Andreas Graber, the two founders of UrbanFarmers

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According to the American Cancer Society, 1 in 6 men will be diagnosed with prostate cancer during his lifetime. There are currently good tools to make the surgery effective for this condition, but the hospital would benefit to have minimally invasive methods and less expensive for this type of interventions. Nearly 85% of hospitals offer only the surgically need to open the patient’s abdomen, which involves high costs due to the complexity of the procedure and the duration of hospital accommodation for people made. For this reason, many smaller institutions have abandoned the practice prostatectomies.

An effective and inexpensive tool for prostate surgery

DistalMotion could change that. The spin-off of EPFL has developed a tool that minimizes the aspects of invasive prostate operations for the same clinical results and is accessible to any type of care. This tool, based on a patented force feedback allows the surgeon to feel closer to the consequences of his actions during the operation and benefit from unmatched precision. Its cost is about one-tenth of robotic systems competitors, which are also significantly bigger.

Member of the team venture leaders 2011, the CEO and cofounder of DistalMotion, Ricardo Beira, with his colleague Lionel Flaction in the role of managing director, hopes to complete its prototype in 6 months. The money raised through venture kick serve entrepreneurs to try to impose their innovation and have enough time to raise more capital to enter the market by 2015.

«Venture kick is a program to support entrepreneurship among the most prolific. More than the money we raised, it is the feedback that we received from jurors and competing teams that proved decisive for the development of our society, “said Ricardo Beira.

Fresh food on the roofs of houses

The global population is growing, and the awareness of the need for a more stingy gas emissions greenhouse has not yet imposed. Nearly 80% of the retail price displayed in supermarkets for products such as salads are yet to cover the cost of shipping and handling. It is in this context that the company has launched UrbanFarmers, which accounts adequately address the system for the production of fresh fish, fruits and vegetables so environmentally friendly, according to a model of “cities of the Future “planned for this century.

UrbanFarmers is positioned as a cleantech in the field of agriculture. This spin-off of the Fachhochschule Wädenswil Zurich was founded in 2011 by Roman Gaus and Andreas Graber. The purpose of these is to provide solutions to enable sustainable and competitive agricultural culture in the city. The impact on the environment, particularly in terms of CO2 emissions, is undeniable, and the model can control the whole production chain.

The company has designed various models of hydroponics or aquaculture operations that produce almost the same place where the products are consumed. No more hassle when the supermarket just go on a greenhouse on the roof of his house to his fresh market or grab a salad in a glass box mounted on the balcony. Obviously, the ecological balance is provided from upstream of the chain tight control of administered nutrients for plants and fish. UrbanFarmers has a pilot farm in LokDepot in the Basel region, which serves as proof of concept and a showcase for the company.

“We are pleased to have closed all stages of venture kick. Our vision of urban agriculture may be ahead of some 20 years for the mass market, but I am convinced that we were able to convince the jury that the range of products we plan to launch was likely to break Thanks to our team and our past successes, “said Roman Gaus, co-founder of UrbanFarmers. The young entrepreneur adds that the early stages of venture kick allowed the company to generate a “buzz” huge, allowing them to raise their first funds.

About venture kick

venture kick is a pre-seed fund supported by Gebert Rüf Stiftung, Ernst Göhner Stiftung, OPO-Stiftung, Avina Stiftung Foundation in 1796 and Lombard Odier Darier Hentsch & Cie. Operational management of the funds entrusted to IFJ Institut für Jungunternehmen, based in St. Gallen, Zurich and Lausanne. The objective of this private initiative is to double the number of spin-off from the Swiss colleges and universities to improve the quality of start-ups and their attractiveness vis-à-vis professional investors. To achieve this goal, venture kick provides seed funding of up to 130,000 francs.

Since its launch in autumn 2008, venture kick awarded funding of approximately CHF 8 million to 219 projects spin-off from the Swiss universities. 155 highly innovative companies have emerged, creating about 1,600 skilled jobs and sustainable for the Swiss economy. Start-ups supported in turn could raise more than 230 million francs in financing volume.

The advantages of endoscopic surgery are many. However, there are also drawbacks, especially for surgeons. Consider the following. Endoscopic surgery lacks fine precision due to the rigid nature of the tools. Moreover, because the surgeon is basically operating a lever (the beam being the surgical instrument and the trocar being the fulcrum), the surgeon’s movements are actually operating in opposite direction, which necessitates extensive training.

Robotic surgery has been developed concurrently with the advancement of electronic and computer technologies with a specific goal of solving some intrinsic problems of endoscopic approach. Surgical robots, such as the da Vinci, allow a surgeon to not only work remotely, but to also be able to effortlessly perform delicate procedures with his or her hands because of the robot’s ability to translate large movements by the surgeon into small movements in the corresponding instruments. However, the surgeon does not have any haptic feedback when instruments come in contact with tissue. Moreover, available surgical robots are very expensive and require a lot of space, a luxury that few hospitals have.

Ricardo Beira, a student at Ecole Polytechnique Federale de Lausanne in Switzerland, and founder of DistalMotion, has developed a device that brings together benefits of both endoscopic and robotic surgery. The device is completely mechanical and consists of a number of small joysticks, which allow the operation of surgical tools fixed to the end of a metal arm using endoscopic surgical techniques. The joysticks replicate the surgeon’s movements and allow for seven degrees of movement, including wrist rotation. The mechanical nature of the device also provides the surgeon force feedback in his or her movements. As the device lacks the sophisticated electronic components found in other surgical robots, DistalMotion’s tool is only about one-tenth the cost of other devices.

Source : http://actu.epfl.ch/news/extending-the-hands-of-the-endoscopic-surgeon/

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Open Minds Exhibition: Grit Leveraged Freedom Chair

Open Minds Exhibition: Grit Leveraged Freedom Chair

Open Minds Exhibition: Grit Leveraged Freedom Chair

Massachusetts Institute of Technology

GRIT draws on the high-level research and development talent at MIT’s academic labs to develop technological solutions to global problems and creates a pathway for proven concepts to progress into products. By uniquely bridging the gap between innovation in academia and implementation in the real world, we can make a significant impact for people around the world.

GRIT is currently focused on scaling up dissemination of the Leveraged Freedom Chair (LFC). The LFC is a lever-powered mobility aid designed for use in developing countries, where existing products cannot cope with the rough terrain. The key innovation behind the device is its simple variable mechanical advantage drivetrain, where the user adjusts hand position on the stow-able levers to change torque and speed, enabling a versatile platform for indoor and outdoor use.

Since the user changes body geometry to effectively “shift gears,” the LFC drivetrain can be made of a simple and robust assembly of bicycle components, making the chair manufacturable and repairable anywhere in the world for the same price or less as current devices to reach the fourteen million people in need of mobility aids in rural areas of developing countries.

The classic wheelchair is a well-known device and is very functional for people with basic mobility needs. Using hand propelled wheels is relatively straight-forward, for the most part, for people to go about their daily business. However, in some developing countries where paved streets and sidewalks are in the form of rocky terrain, hills and muddy roads, the basic wheelchair design suddenly starts showing its shortcomings. This observation is what led Amos Winter and his team at MIT to bring from concept to product the Grit Leveraged Freedom chair, a lever powered wheelchair. The rider can adjust the mechanical advantage by moving hands up and down the levers powering the wheelchair, allowing them to easily work in different terrain. In addition, the wheelchair is made from basic bicycle parts allowing for easy maintenance and repair.

We had a chance to ask Benjamin Judge from the team some questions about their product.

Justin Barad, MD, Medgadget: What gave you the idea to come up with this concept?

In 2005 Amos Winter, then a graduate student at MIT, traveled to Tanzania as part of an internship with Whirlwind Wheelchair International, a group that works with wheelchair riders around the world to design appropriate mobility aids. Amos wanted to understand how people who needed wheelchairs got around and how well current wheelchair technology met peoples’ mobility needs. What he quickly learned was that people in wheelchairs often could not travel where they needed to go. Individuals must cope with narrow doorways, steep hills, bumpy, muddy roads and long distances to destinations like school and work. All of these issues make it extremely difficult to get anywhere with a conventional wheelchair. The other existing option in developing countries is the hand-powered tricycle, but it’s too large for indoor use and too heavy to maneuver over rough terrain. Our team set about designing a wheelchair that would allow users to both travel long distances over rough terrain and also navigate indoor spaces. The product should empower users to independently travel where they want to go, allowing them to access resources and employment. And most importantly, it should be affordable.

Like a mountain bike, this new wheelchair had to have a large range of mechanical advantage; a low gear for traveling up hills and through mud and a high gear for traveling on smooth, flat ground. Amos realized that a lever grasped at different positions changes the effective lever length and creates the type of mechanical advantage needed.

Medgadget: What’s the make-up of your team?

The LFC was developed through the MIT Mobility Lab, which Amos created in 2007. The core team joined the project during their studies in MIT’s Department of Mechanical Engineering. The team has collaborated closely with wheelchair manufacturers and riders throughout the development of the LFC, engaging them in the design process. The team recently founded a non-profit, Global Research Innovation and Technology (GRIT), to manage the scale-up and distribution of the LFC. The GRIT team represents the core designers of Mobility Lab technology, all of whom have spent extensive time abroad to develop and field-test the LFC and were all MechE students in Amos’ wheelchair design program. They have 19 years of collective experience working as a team in the space.

Main team members:

Mario Bollini- Second year graduate student in mechanical engineering focusing on robotics in MIT’s Computer Science and Artificial Intelligence Laboratory. Mario has been working on wheelchair technology projects since 2007, developing much of the LFC’s intellectual property. He will be joining GRIT in the summer of 2012 as the Director of Engineering.

Ben Judge- MIT grad student in manufacturing. His SB mechanical engineering thesis on a US LFC design and market viability of the LFC United States and other developed countries. Ben has been leveraging an ongoing relationship with Continuum Design to explore wheelchair concepts and will be establishing collaborations on the project with bicycle and wheelchair component manufacturers as he continues the product development research with the support of the Singapore University of Technology and Design (SUTD).

Tish Scolnik- currently the Executive Director of GRIT, a nonprofit startup that aims to improve the quality of life for people around the world by bridging the gap between innovation in academia and implementation in the real world. She graduated from MIT in 2010 with an SB in Mechanical Engineering and a minor in Applied International Studies. While at MIT she made four trips to East Africa where she worked with local wheelchair technicians to help them improve their designs such they better meet user needs. She has previously worked at the World Bank and the US Department of Health and Human Services.

Amos Winter- founded the Mobility Lab upon his initial survey of wheelchair technology in East Africa. He has authored LFC academic papers and is completing his post-doctoral research and conducting field trials of the LFC in India in 2012. Amos will soon be joining MIT Mechanical Engineering Faculty and will lead a lab focusing on design for highly constrained environments, with a particular focus on emerging markets. He plans to facilitate the transition of his market viable research to be further developed by GRIT.

There are also countless others that have helped in various capacities to keep the LFC project going and now supporting GRIT as it gets off the ground.

Medgadget: What was the biggest obstacle you have faced so far trying to make this concept a reality?

The biggest challenge we are facing is figuring out how to transition the LFC from an academic project to a viable product. In academia, we were rewarded for producing scholarly work, but in order to actually get the LFC into the hands of wheelchair riders across the globe, we need a whole different set of knowledge about manufacturing, intellectual property, distribution networks, and funding mechanisms. The research and development of the LFC was funded through a variety of academic sources, but these are not a viable long-term solution. We’re quickly learning how to run an actual organization; how to manage contracts, solicit donors, and build a strategy. With the founding of GRIT and the transition away from being a student group, we are on the right path, but dealing with growing pains. We currently have enough funding for only one full-time staff person, with other team members pitching in their spare time. We have big ambitions, but require additional funding and more manpower to make it happen. The lead time on grants can be significant, making it difficult to manage short-term cash needs. (We know that having experience struggling to get the LFC project implemented will give us the valueable knowledge in this space to take on new academic spin offs in the future – continuing the GRIT process.

Medgadget: What kind of user feedback have you gotten so far regarding your technology?

The LFC has progressed through four generations of iterative design and we have conducted three rounds of field trials on three continents. In 2009 we tested 6 chairs in East Africa (Kenya, Tanzania and Uganda). After four months of testing, biomechanical performance data was collected from the LFC riders. It illustrated that the chair was superior to existing mobility aids as far as rider efficiency and off-road performance, but still required refinement to be a viable product. The trial subjects identified that the LFC had to be narrower to fit indoors, lighter for transportation and more stable when climbing hills. Through the next year, we worked with community partners and stakeholders, principally with the Transitions Foundation of Guatemala and Antigua, to improve the design and prepare it for another user trial. A lighter, narrower chair was distributed for testing in Guatemala in 2010.

The final, pre-production trial of the LFC was completed in 2011 in India in collaboration with Jaipur Foot, the largest disability group in the world in terms of assistive device distribution. This trial verified the superiority of the LFC outdoors, showing it to be 75% faster than a conventional wheelchair on an average commute. Additionally, the streamlined size made it much easier to navigate indoors, with trial participants ranking it on par with conventional wheelchairs.

In the India trial, rural patients, who were previously using a standard wheelchair, had about 90% (10/11 patients) adoption rate. We saw drastic changes in quality of life, with most of these patients housebound before the LFC and now traveling 2-3km/day. Several have gained employment as a result of being able to travel in the LFC.

Medgadget: What kind of cost difference would there be between your technology and the currently available standard?

The LFC is being manufactured for the same cost as existing products, while offering greater capability. The LFC drivetrain is built from a simple, single-speed assembly of bicycle components. These bike parts are ubiquitous in developing countries, making it easy to maintain and repair the product, and contributing to its low cost.

Currently people have to choose between a hand-powered tricycle and a conventional push-rim wheelchair. The tricycle provides good mobility on long distances of flat terrain, but is too bulky to use indoors. The conventional wheelchair, while useful indoors, is inefficient for outdoor travel. And neither product performs well on hills or rough terrain. These products are typically charity-funded and cost about $150 per chair to the donor.

Of note:

While the LFC was designed for developing world users, many of the features of the LFC are of interest to manual wheelchair users in developed countries, too. US and European users have inquired about the product, citing the need for a versatile off-road device in their lives. In response, we have worked with Design Continuum to coneptualize a version of the LFC for the developed world market—the LFC Sport. Building upon the proven leveraged drivetrain of the original LFC, we are creating a mobility device that meets the unique demands of wheelchair users in developed countries. A US product concept is an interesting example of “trickle-up” engineering, using effective low cost mechanisms to decouples a user’s desire for more effective mobility from their need for insurance subsidy. It may even be offered at a price attractive enough for the user to pay for out-of-pocket as a complementary device. The LFC family would provide mobility for every terrain and every wallet in the world.

Source : http://nciia.org/openminds/2012/lfc

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ITClamp Stops Traumatic Bleeding in Combat Zones

ITClamp Stops Traumatic Bleeding in Combat Zones

ITClamp Stops Traumatic Bleeding in Combat Zones

Bleeding is the single largest cause of preventable trauma death, and when our armed forces are out in the combat zone, stopping a bleeding wound can be difficult. Dr. Dennis Filips, a retired trauma surgeon from the Canadian Navy and CEO of Edmonton, AB-based Innovative Trauma Care, saw a lot of bleeding while serving in Afghanistan, and wondered if there could be a way to reduce the mortality rate from traumatic hemorrhage other than using tourniquets and hemostatic wound agents, which take time to apply.

Inspired by a simple hair clip, Filips designed a device called the ITClamp. The ITClamp is essentially a sterile, plastic clamp approximately five centimeters in length, with curved needles along the “jaws” of the device. In a trauma situation, the responder clamps the device along the wound. The curved needles and the shape of the ITClamp draw the wound up into the device and anchor it with even pressure, allowing the blood underneath to create a clot around the wound and help stop the bleeding until the victim receives further medical attention.

The ITClamp can be applied in a matter of seconds and can used by basically anyone with minimal training. The device only costs about $65, so it’s affordable for military units, hospitals, and paramedics anywhere, but it’s yet to clear the regulatory process before it becomes available.

Here’s a demo video of how the ITClamp works:

[Edmonton, Alberta, Canada] Innovative Trauma Care™ (ITC), an early stage medical

device company focused on developing and marketing point of injury solutions to the first responder, military and trauma markets, received the Life Sciences Technology award from the Banff Venture Forum held on October 7, 2011 at the organization’s 13th annual forum. Banff Venture Forum is the premier company financing event in Canada and winners were selected from event attendees.

The Banff Venture Forum showcases early and growth stage companies in three streams: Information Technology, Energy Technology and Life Sciences Technology. Event attendees present to investors from across North America with the ultimate goal of securing financing needed to grow their businesses.

“We are honored to be selected as the best company in the Life Sciences category. The high caliber of presenting companies and investors was extremely competitive, and we are grateful to receive such a prestigious recognition,” commented ITC’s founder and CEO Cdr (Ret’d) Dennis Filips, MD, FRCSC.

ITC expects to launch its first product, the ITClamp, in late 2012. The ITClamp was

designed to address massive hemorrhage – a leading cause of death in traumatic injury – by controlling critical bleeding in as little as 5 seconds. The clamping device works by sealing the skin closed to create a temporary pool of blood under pressure, which forms a stable clot until the wound can be surgically repaired.

Incorporated in 2010 and based in Edmonton, Canada, Innovative Trauma Care is

addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing poin tof injury solutions to treat common causes

of preventable death in traumatic injury scenarios.

Source : http://itraumacare.com/pages/news.html

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Johns Hopkins Group Boosts Epilepsy Algorithm to Help Reduce Needless Brain Stimulation

Johns Hopkins Group Boosts Epilepsy Algorithm to Help Reduce Needless Brain Stimulation

Johns Hopkins Group Boosts Epilepsy Algorithm to Help Reduce Needless Brain Stimulation

Epilepsy affects 50 million people worldwide, but in a third of these cases, medication cannot keep seizures from occurring. One solution is to shoot a short pulse of electricity to the brain to stamp out the seizure just as it begins to erupt. But brain implants designed to do this have run into a stubborn problem: too many false alarms, triggering unneeded treatment. To solve this, a Johns Hopkins biomedical engineer has devised new seizure detection software that, in early testing, significantly cuts the number of unneeded pulses of current that an epilepsy patient would receive.

Sridevi V. Sarma, an assistant professor of biomedical engineering, is leading this effort to improve anti-seizure technology that sends small amounts of current into the brain to control seizures. “These devices use algorithms—a series of mathematical steps—to figure out when to administer the treatment,” Sarma said. “They’re very good at detecting when a seizure is about to happen, but they also produce lots of false positives, sometimes hundreds in one day. If you introduce electric current to the brain too often, we don’t know what the health impacts might be. Also, too many false alarms can shorten the life of the battery that powers the device, which must be replaced surgically.”

Her new software was tested on real-time brain activity recordings collected from four patients with drug-resistant epilepsy who experienced seizures while being monitored. In a study published recently in the journal Epilepsy & Behavior, Sarma’s team reported that its system yielded superior results, including flawless detection of actual seizures and up to 80 percent fewer alarms when a seizure was not occurring. Although the testing was not conducted on patients in a clinical setting, the results were promising.

Sridevi Sarma, assistant professor of biomedical engineering at The Johns Hopkins University. Photo by Will Kirk/Homewoodphoto.jhu.edu

Sridevi Sarma, assistant professor of biomedical engineering at The Johns Hopkins University. Photo by Will Kirk/Homewoodphoto.jhu.edu

“We’re making great progress in developing software that is sensitive enough to detect imminent seizures without setting off a large number of false alarms,” she said. Further fine-tuning is under way, using brain recordings from more than 100 epilepsy patients at Johns Hopkins Hospital, where several epilepsy physicians have joined in the research. Sarma said that within two to four years she hopes to see her system incorporated into a brain implant that can be tested on people with drug-resistant epilepsy.

“There is growing interest in applying responsive, or closed-loop, therapy for the treatment of epileptic seizures,” said Gregory K. Bergey, M.D., professor of neurology and director of the Johns Hopkins Epilepsy Center. “Devices to do this have been tested in humans, but for this therapy to be useful for the patient with epilepsy requires early detection of abnormal brain activity that is destined to become a seizure. Detection has to be within seconds of seizure onset, before the seizure spreads to cause disabling symptoms such as alteration of consciousness.”

He added, “Developing detection methods that can both provide this early detection and yet not be triggered by brain activity that will not become a clinical seizure has been a real challenge. Dr. Sarma’s group appreciates how important this is. The application of their detection algorithms has produced promising preliminary results that warrant further study of more seizures in more patients.”

Sridevi Sarma’s research focuses on a system with three components: electrodes implanted in the brain, which are connected by wires to a neurostimulator or battery pack, and a sensing device, also located in the brain implant, which detects when a seizure is starting and activates the current to stop it.

Sridevi Sarma’s research focuses on a system with three components: electrodes implanted in the brain, which are connected by wires to a neurostimulator or battery pack, and a sensing device, also located in the brain implant, which detects when a seizure is starting and activates the current to stop it. (Illustration by Greg Stanley/JHU)

In trying to solve the seizure false-alarm problem, Sarma drew on her training in electrical engineering, particularly a discipline called control theory. “We decided to start with the origin of the signal in the brain,” she said.

Sarma’s team compared electrical data from the brains of epilepsy patients before, during and after seizures. The researchers looked at how this activity changed over time, particularly when a seizure began. “We wanted to figure out when would be the optimal time to step in with treatment to stop the seizure,” she said. The team members “trained” their system to look for that moment without setting off false alarms.

Ideally, Sarma would someday like to see her software embedded in a microchip that would continually check electrical activity in the brain and launch electrical stimulation whenever a seizure is just beginning to form. The device would operate as a closed loop system, resembling a thermostat that keeps a room’s temperature at a constant, comfortable level.

Sarma’s interest in brain disorders developed relatively late in her education. She earned a bachelor’s degree from Cornell University in electrical engineering, then master’s and doctoral degrees at MIT, both in electrical engineering and computer science. During her doctoral studies, however, she pursued a minor in neuroscience. For a class, she conducted a case study of her aunt, who had developed Parkinson’s disease at age 29 and had trouble managing it with medication. Watching her aunt’s condition was an emotionally draining experience, Sarma said, and she wondered if anything in her own training could help. “I really wanted to understand the neurobiological circuitry of this disease,” she said.

That led Sarma to learn more about deep brain stimulation—the use of electric pulses to treat brain disorders such as Parkinson’s and epilepsy. She completed a postdoctoral fellowship in MIT’s Brain and Cognitive Sciences Department and became a neuroscience research associate affiliated with Massachusetts General Hospital and Harvard Medical School.

In 2009, Sarma joined the faculty of Johns Hopkins’ Department of Biomedical Engineering, which is shared by the School of Medicine and the Whiting School of Engineering. She also is a core faculty member in the university’s Institute for Computational Medicine. In 2011, Sarma was named a recipient of a Faculty Early Career Development Award from the National Science Foundation.

Her team’s new system for seizure detection with reduced false alarms is protected by a patent obtained through the Johns Hopkins Technology Transfer office.

Lead author of the Epilepsy & Behavior journal article was Sabato Santaniello, a postdoctoral fellow in Sarma’s lab. Along with Sarma, co-authors were Samuel P. Burns of the Johns Hopkins Department of Biomedical Engineering; Alexandra J. Golby of Brigham and Women’s Hospital in Boston; Jedediah M. Singer of Children Hospital, Boston; and William S. Anderson of the Johns Hopkins Department of Neurosurgery.

Epilepsy affects 50 million people worldwide, and seizures in 30% of the cases remain drug resistant. This has

increased interest in responsive neurostimulation, which is most effective when administered during seizure

onset. We propose a novel framework for seizure onset detection that involves (i) constructing statistics

from multichannel intracranial EEG (iEEG) to distinguish nonictal versus ictal states; (ii) modeling the dynamics

of these statistics in each state and the state transitions; you can remove this word if there is no room.

(iii) developing an optimal control-based “quickest detection” (QD) strategy to estimate the transition times

from nonictal to ictal states from sequential iEEG measurements. The QD strategy minimizes a cost function of

detection delay and false positive probability. The solution is a threshold that non-monotonically decreases

over time and avoids responding to rare events that normally trigger false positives. We applied QD to four

drug resistant epileptic patients (168 hour continuous recordings, 26–44 electrodes, 33 seizures) and achieved

100% sensitivity with low false positive rates (0.16 false positive/hour).

This article is part of a Supplemental Special Issue entitled The Future of Automated Seizure Detection and

Prediction.

Automatic online seizure detection (AOSD) in intractable epilepsy

has generated great interest in the last 20 years and is a fundamental

step toward the development of neurostimulation-based responsive

antiepileptic therapies [1–3]. Pioneering works in the late 1970s

and early 1980s by Gotman et al. [4,5] showed that seizures can be

automatically separated from interictal activity, and since then,

several approaches to AOSD have been proposed by exploiting either

scalp or intracranial EEG recordings, single or multichannel analysis,

linear or nonlinear features.

Osorio et al. [6–9] used a wavelet-based decomposition of selected

intracranial EEG recordings (iEEGs) to (i) separate the seizure-related

component from the background noise, (ii) track the ratio between

these components in the time–frequency domain, and (iii) detect a

seizure when such a ratio crosses a .xed threshold for a suf.ciently

long time. Parameters of the detection method (e.g., threshold,

Researchers at Johns Hopkins have been working on a way to improve the precision and effectiveness of seizure controlling brain implants by trying to eliminate false positives that needlessly trigger electrical pulses.

Sridevi V. Sarma, an an assistant professor of biomedical engineering at Hopkins with a background in electrical engineering and computer science, led the team that developed new algorithms that so far have been tested on brain recordings taken from four drug-resistant epileptics. The hope is that soon this algorithm will be tested in implanted devices of real patients in a proper clinical study.

From a Hopkins press release:

In a study published recently in the journal Epilepsy & Behavior, Sarma’s team reported that its system yielded superior results, including flawless detection of actual seizures and up to 80 percent fewer alarms when a seizure was not occurring. Although the testing was not conducted on patients in a clinical setting, the results were promising.

Further fine-tuning is under way, using brain recordings from more than 100 epilepsy patients at Johns Hopkins Hospital, where several epilepsy physicians have joined in the research. Sarma said that within two to four years she hopes to see her system incorporated into a brain implant that can be tested on people with drug-resistant epilepsy.

Sarma’s team compared electrical data from the brains of epilepsy patients before, during and after seizures. The researchers looked at how this activity changed over time, particularly when a seizure began. “We wanted to figure out when would be the optimal time to step in with treatment to stop the seizure,” she said. The team members “trained” their system to look for that moment without setting off false alarms.

source : http://releases.jhu.edu/2012/04/02/new-early-warning-system-for-seizures-could-lead-to-fewer-false-alarms/

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