Archive for ‘Medical Research’

Page 1 of 612345...Last »

MOCACARE Reveals MOCACuff: a New Wireless Wrist Blood Pressure Monitor

MOCACARE Reveals MOCACuff: a New Wireless Wrist Blood Pressure Monitor

mocacuff-3

 

Hypertension affects more than 70 million adults in the United States, and even more individuals remain undiagnosed. Hypertension increases the risk of developing other serious health conditions, such as heart attacks, kidney damage, and stroke. Even though there are multiple devices on the market that enable people to track their blood pressure at home, consumer adoption of these self-monitoring devices has remained somewhat limited due to persistent deficits in design, portability, accuracy, and/or usability.

MOCACARE, a Silicon Valley company focused on developing consumer cardiovascular monitoring devices–with their flagship product, MOCAheart–just unveiled their cutting edge, wireless, and automatic wrist blood pressure monitor, MOCACuff. We at Medgadget were one of the first to test this new device to see what sets it apart from other currently available home blood pressure monitors. MOCACuff has been granted FDA clearance in the United States and is CE-Certified in the European market.

Design and Fit:

The MOCACuff is stored in a small, streamlined case that is black, rigid, and has a zipper closure. As the MOCACuff monitors blood pressure at the wrist, it is smaller in size and offers a more comfortable fit than bulkier devices that monitor blood pressure at the upper arm. This also makes the MOCACuff and its container more discreet and portable than many of the other devices on the market. The device itself is made up of hard plastic with an LCD screen attached to a soft, black wrist strap that folds in on itself for storage. The wrist strap is curved and rigid on one end to hook onto the user’s wrist, which frees up the user’s other hand to tighten the Velcro strap without difficulty. The display screen is about 1 5/8 inch x 1 3/8 inch in area, but it remains very easy to read. To the right of the display screen is a color-coded indicator made up of a vertical series of dots that begins with green and transitions to orange and then red to show users how their blood pressure reading compares to the American Heart Association’s blood pressure categories (i.e. green is optimal and red suggests hypertension).

Set up:

mocacuff-appSetting up the MOCACuff device was simple and straightforward. It is powered by AAA batteries, which are included. The first thing you do with your new device is set up the time and date and then follow the five steps outlined on the included instruction card in order to download the free MOCACARE app – available for both iOS and Android – and sync the device to your smartphone. This syncing capability allows users to track their blood pressure and heart rate readings over time. A more detailed user manual is also included to review all the features offered by the MOCACuff.

Accuracy:

One concern with wrist-based blood pressure cuffs is that they tend to be less accurate than upper arm devices. When I compared the MOCACuff blood pressure reading to an available upper arm device, I found the readings to be within 5 mmHg of each other. Also, the accuracy of the MOCACuff improved when I placed my tested arm across my chest as outlined on the instruction card. The MOCACuff has been clinically tested against a mercury sphygmomanometer, the gold standard for blood pressure measurement, and the MOCACuff accuracy is described as ±3 mmHg for pressure and ±5% Max for pulse.

Usability:

After donning the cuff, the user pushes the start/stop button to begin cuff inflation. The inflation process is relatively quiet and comfortable, as excessive overinflation does not occur with this device.  The pulse and blood pressure readings appear on the LCD screen immediately after deflation of the cuff. The screen also indicates any irregular heartbeat that is present. Bluetooth technology allows the measurements to be transferred to the MOCACARE app with one push of a button on your smartphone. Users can easily review their measurements in sequential order and visually track the changes in their blood pressure over time. The app also categorizes a user’s measurements based on the American Heart Association’s guidelines and offers advice below each reading on how to improve the user’s heart health through lifestyle modifications. Users may also share their measurements with their healthcare providers without having to write these readings down on paper.

Conclusion:

Overall, I believe the MOCACuff adequately addresses the limitations apparent in other self-monitoring blood pressure devices. It is sleek, comfortable, user-friendly, highly portable, and reasonably priced at $69.99. In my opinion, one of the best features of the MOCACuff is the included MOCACARE app for your smartphone, which, for iOS users, syncs with Apple Health.  Not only does the app allow users to monitor their heart rate and blood pressure, but it also empowers users to make a positive change in their heart health through helping them understand their measurements, share results, and directly visualize their progress over time.

mocacuff

MOCACuff specs:

Display (LCD): Liquid Crystal Display

Device Size: 135~195mm (5.3~7.7inch)

Device Weight :97.5g ± 10 g (3.44 oz ± 0.35 oz)

Unit Dimension: 74 X 74.5 X 30.5 mm (L X W X H)

2.91 X 2.93 X 1.20 inch (L X W X H)

Battery Life: DC 3 V, AAA Alkaline Battery x2, Approx. 200   measurements

Bluetooth: Bluetooth 4.0 / BLE (Bluetooth Low Energy)

Compatibility: Operates on iOS 8 or higher, Android 4.0.3 or higher. May not be compatible with certain models.

Full story

Exogen Bio How damaged is your DNA?

Exogen Bio How damaged is your DNA?

DNA damage Exogen Bio Wants Your Blood to Test for DNA Damage

 

Maintaining the health of your DNA is important ,because it contains the genetic information that make up who you are. You might be surprised to learn that your DNA is constantly being damaged and broken. DNA damage can come from exposure to UV rays, medical x-rays, and some chemical toxins from your environment. DNA damage can also be affected by your genetics and by lifestyle choices like diet and physical exercise. It is important to minimize damage to your DNA because scientists have linked DNA damage and poor repair to cancer, neurological diseases, accelerated aging,and many other serious medical conditions.

The DNA in our cells is subject to a lot of stress, and often the molecule breaks and becomes defective. There are mechanisms that exist to repair damaged DNA, but too often those are insufficient and the damaged DNA proliferates, potentially causing cancer and some other diseases. Exogen Bio, a Lawrence Berkeley National Lab spin-off, has commercialized technology that can detect broken DNA strings in blood samples, and has asked for help from the crowd to better understand what such testing can reveal.

The company has taken to Indiegogo, offering to “monitor the health of your DNA” by quantifying the frequency of damaged DNA strings. The basic deal is that for $79 you get a kit through which you share three samples of blood taken on consecutive days. In return you get data on how damaged is the DNA in the samples, and compared to other people. As part of the campaign, Exogen Bio gets to use the data it collects from everyone’s samples  to learn more about DNA damage and  this kind of testing can be beneficial for health monitoring…

Press release: Exogen Biotechnology Launches First of Its Kind DNA Health Monitoring Campaign on Indiegogo and Raises $20K Within First Three Days…

 

 

 

 

Full story

LEGO Robots Help Grow Bones

LEGO Robots Help Grow Bones

LEGO Robots Help Grow Bones

Engineering isn’t all glamour. In the course of devising and producing the stuff that improves all our lives, the lab often becomes home to laborious procedures that can start to sap the strength of even the hardiest engineers.

Researchers at the Department of Engineering developing synthetic bone have struck upon a novel way of getting round this – by using classic kids construction kit Lego – and their innovative use of mechanical toys in world-leading research has been featured in a new video produced by internet giant Google.

The video, which has already had over 100,000 views, goes behind the scenes at the lab to show how the team develop the bone samples.

Bone has excellent mechanical properties for its weight, and synthetic bone has a range of revolutionary applications; from the obvious, such as medical implants, to the almost science fiction, such as a material in building construction. But the process involved in producing samples of bone is tedious and time consuming.

“To make the bone-like substance you take a sample, then you dip it into one beaker of calcium and protein, then rinse it in some water and dip in into another beaker of phosphate and protein – you have to do it over and over and over again to build up the compound,” says Daniel Strange, one of the PhD students working on the research.

The team started to think about ways of automating the arduous process – the ideal being a robot of some kind that they could set up and run in the background. “One way would be to buy very expensive kit off the shelf,” says Strange. “But when we thought about it Lego just seemed like the simplest, and cheapest, way to go about things.”

After a bit of investigation the researchers decided to build cranes from a Lego Mindstorms robotics kit, which contains microprocessors, motors, and sensors that can be programmed to perform basic tasks on repeat. The sample is tied to string at the end of the crane which then dips it in the different solutions.

The team quickly discovered that the miniature machines made from the famous plastic blocks vastly reduced the human time cost of creating the bone samples: “the great thing about the robots is once you tell them what to do they can do it very precisely over and over again – so a day later I can come back and see a fully made sample,” says Strange.

Dr. Michelle Oyen, team leader and lecturer in the engineering department, added: “Research is a funny thing because you might think that we order everything up from scientific catalogues – but actually a lot of the things we use around the lab are household items, things that we picked up at the local home goods store – so our Lego robots just fit in with that mind-set.”

Bone defects can result from trauma, infection and the removal of tumours, and beyond a certain size of trauma bone is unable to regenerate itself. Current treatments include bone grafts, which can be risky and greatly increase recovery time.

The team at Cambridge are working on hydroxyapatite–gelatin composites to create synthetic bone, and the work is generating considerable interest due to the low energy costs and improved similarity to the tissues they are intended to replace.

The video was made in the lab at the Department of Engineering by Google to help promote their online Science Fair, an international competition run by the company to encourage teenagers to engage with science. On the competition website, Google state that they are “seeking curious minds from the four corners of the globe. Anybody and everybody between 13 and 18 can enter. All you need is an idea.” The submission deadline for entering the Google Science Fair is 1 April.

Researchers at the Department of Engineering at Cambridge University have enlisted the help of some custom made LEGO robots to grow artificial bone samples. In order to build up the bone grafts, a scaffold needs to be repeatedly dipped in a number of different solutions to grow the compound, a highly repetitive task that lent itself to a little bit of home-brewed automation.

The team built cranes from a Lego Mindstorms robotics kit, which contains micro-controllers, actuators, and sensors that can be programmed to perform sequential tasks. The synthetic bone scaffold was tied to a string at the end of the crane, and the whole setup was able to perform the sequential layering needed to grow the composite bone.

The project is outlined in the video below, which was produced by the folks at Google to help promote their online Science Fair. The video demonstrates the robots in action and explains the process of growing the synthetic bone.

Source : http://www.cam.ac.uk/research/news/growing-bones-with-lego/

Full story

Steven Palter Helps Bring Web Tech to Peer-Reviewed Articles

Steven Palter Helps Bring Web Tech to Peer-Reviewed Articles

Steven Palter Helps Bring Web Tech to Peer-Reviewed Articles

Authors: Luiz Caravalho, Rebecca Flyckt, Pedro Escobar, Tommaso Falcone

Cleveland Clinic, Cleveland, Ohio

Capsule: Knowledge of abdominal wall anatomy can facilitate surgical access for a single site or single port laparoscopy

Objective: Single Port Laparoscopic (SPL) surgery has reduced the number of sites required to perform laparoscopic surgery.1-3 However, the incision at the umbilicus is larger than conventional laparoscopic surgery. The objective of this video is to demonstrate the abdominal wall anatomy necessary to perform a single port laparoscopic procedure. Design: Video presentation of clinical article. The video uses animation and surgical cases to demonstrate the relevant abdominal wall anatomy to establish surgical access for a single site or single port laparoscopy.

Results: This video demonstrates the regional anatomy pertinent to the anterior abdominal wall specifically of the umbilicus. The umbilicus is a focal point of fusion of the anterior abdominal wall muscles that allows entry into the peritoneal cavity. For this procedure there are 2 incisions possible, a small midline intra-umbilical one and am omega incision. The video demonstrates each technique. Introduction of a port into this single incision is demonstrated with 2 different trocar systems. These trocar systems show how the limitations of using a single site may be reduced.

Conclusion: The abdominal wall anatomy is unique at the umbilicus and allows optimal placement of a single trocar to allow laparoscopic surgery.

References

Escobar PF. Fader AN. Paraiso MF. Kaouk JH. Falcone T. Robotic-assisted laparoendoscopic single-site surgery in gynecology: initial report and technique. Journal of Minimally Invasive Gynecology. 2009:589-91.

Escobar PF. Bedaiwy MA. Fader AN. Falcone T. Laparoendoscopic single-site (LESS) surgery in patients with benign adnexal disease. Fertility & Sterility. 2010; 93:e7-10.

Escobar PF, Kebria M, Falcone T. Evaluation of a novel single-port robotic platform in the cadaver model for the performance of various procedures in gynecologic oncology. Gynecol Oncol. 2011 120:380-38

Conclusion: The abdominal wall anatomy is unique at the umbilicus and allows optimal placement of a single trocar to allow laparoscopic surgery.

Washington DC (June 19, 2012) – Fertility and Sterility, the flagship journal of the American Society for Reproductive Medicine (ASRM) and its publisher Elsevier, announce the first-ever publication of a new multimedia article format that integrates video and traditional print research.

Online video and traditional print were previously two separate and unrelated worlds in scientific research. The new mechanism allows videos to be cited the same way as a written article in a traditional print medical journal and seamlessly unifies online multimedia content and print journals. Researchers can watch footage of innovations and techniques and learn previously inaccessible information in new non-written formats while still being able to find this information through traditional medical print sources.

“For the last 200 years, medical publishing remained unchanged. Our solution accommodates non-print work through fully integrated multimedia, opens up a whole new form of learning, and allows readers to become part of an ongoing interactive discussion,” says Dr. Steven Palter, the Video and New Media Editor of Fertility and Sterility. Dr. Palter, who developed the concept and spearheaded the project, says “With this effort, we have bridged the gap separating the digital and traditional medical literature. This integration will lead to exciting new directions in research.”

The new media initiative is unique in several ways. It allows an article to exist simultaneously online and in the traditional medical journal and it enables videos to be citable publications for all traditional journals. Fertility and Sterility embeds an open access link in the article that appears both in PubMed and the Journal’s electronic tables of contents, and also in the print journal. QR codes associated with each article seamlessly bring readers from print journal to online video. Authors can create review articles, experimental techniques, anatomic overviews, case reports, and more. Videos, which are peer reviewed as part of the mainstream submission process are served open source through Google’s YouTube.

Craig Niederberger MD, Co-Editor-in-Chief of Fertility and Sterility said, “We are committed to using modern communication methods, from online video to social media to enhance Fertility and Sterility. Medical journals are about conveying new information and new discoveries to others in the field. We simply cannot rely on print alone to do that anymore.”

Antonio Pellicer, MD, Co- Editor-in-Chief of the journal, said, “Medicine has always been an international pursuit. Now with online distribution of multimedia articles the sharing of knowledge can occur even faster, indeed simultaneously around the globe, thus improving patient care more quickly and without regard to geography.”

The first article “Single port laparoscopy” is authored by L. Carvalho et al from the Cleveland Clinic, and appears in the May 2012 issue of Fertility and Sterility and shows a new surgical principle. The abstract both on-line and in the print publication leads to an online video showing the technique: http://fertstertforum.com/2012974caravalho. The article is currently indexed in PubMed at http://www.ncbi.nlm.nih.gov/pubmed/22542145.

The second article, “Chromosome transfer in mature oocytes,” is authored by M. Tachibana et al. From the Oregon National Primate Research Center and also appears in the May 2012 issue of Fertility and Sterility. The video which demonstrates the innovative laboratory technique is at http://fertstertforum.com/2012974tachibana. The article is currently indexed in PubMed at http://www.ncbi.nlm.nih.gov/pubmed/22542144.

With this innovation, ASRM and Elsevier have embraced the digital revolution that has rapidly transformed traditional publishing. Just as the Amazon Kindle brought epublishing to the masses, the new video article initiative of Fertility and Sterility bridges the gap between online multimedia and traditional medical research publishing.

The American Society for Reproductive Medicine, founded in 1944, is an organization of 8,000 physicians, researchers, nurses, technicians and other professionals dedicated to advancing knowledge and expertise in reproductive biology. Affiliated societies include the Society for Assisted Reproductive Technology, the Society for Male Reproduction and Urology, the Society for Reproductive Endocrinology and Infertility, the Society of Reproductive Surgeons, and the Society of Reproductive Biologists and Technologists.

Congratulations to our old friend Steven Palter, MD who’s been working with Elsevier and the American Society of Reproductive Medicine to birth a “video article format” with all the rigor of peer-reviewed publications, indexing through PubMed, but with the open commentary of the web and accessibility of YouTube.

From Dr. Palter’s blog, Doc in the Machine:

The project began with my frustration at seeing medical research shoehorned into an an antiquated print system that precluded any leverage of the power of modern digital research and communication.

Online video and traditional print were previously two separate and unrelated worlds in scientific research. I was astounded when i saw online journals that described how traditional print research couldn’t allow multimedia content. It was obvious that we needed to find a mechanism to radically change medical research from within the system rather than try to build something new and reject a system used by all of scientific research.

The new mechanism allows videos to be cited the same way as a written article in a traditional print medical journal and seamlessly unifies online multimedia content and print journals. Researchers can watch footage of innovations and techniques and learn previously inaccessible information in new non-written formats while still being able to find this information through traditional medical print sources.

Source : http://fertstertforum.com/2012974caravalho/

Full story

A Jet Tour of Northeast Indiana’s Medical Device Hub

A Jet Tour of Northeast Indiana’s Medical Device Hub

A Jet Tour of Northeast Indiana’s Medical Device Hub

This past week, Medgadget was invited to take a tour of Northeast Indiana, a region of ten counties surrounding and encompassing the city of Fort Wayne. You might already know about Warsaw, about 30 miles from Fort Wayne, as the headquarters for DePuy, Biomet, Zimmer, and a number of other companies that make the city the leading orthopedic device leader in the world. However, the rest of Northeast Indiana has also been evolving into a thriving medical device manufacturing hub, as labor is available, land is plentiful, and the region is very open and friendly toward the medical device manufacturing industry. In fact, according to the Northeast Indiana Regional Partnership, our host for the two day tour, the region has consistently been a leader in terms of dollars invested and jobs created in the industry. Over two days, we toured a number of different companies and talked to a number of executives about what makes their businesses successful and why they’re at a good place being in Northeast Indiana.

Micropulse offices A Jet Tour of Northeast Indianas Medical Device HubOur first stop was Micropulse, a contract manufacturer of implants and instruments for a number of large medical device clients. Micropulse was originally founded to produce parts for the automotive industry, but in the early 2000?s, founder and CEO Brian Emerick saw his business growing stagnant, and so he switched to medical devices and has Iotron A Jet Tour of Northeast Indianas Medical Device Hubnever looked back since. What’s interesting about Micropulse is that its facilities are also headquarters to the OrthoVation Center, a new incubator for Emerick’s other medical product ventures. The OrthoVation Center currently is home to four companies: Del Palma Orthopedics, Nanovis, BioSpine, and Sites Medical.

The next stop on our tour was a company that uses state-of-the-art technology to sterilize medical devices and other products. Vancouver-based Iotron recently opened a $15 million sterilization facility in the area and wanted to show us around.

Unlike current sterilization technologies that use gamma radiation or ethylene oxide gas, Iotron uses an electron beam for irradiation, which allows for much faster processing and greater flexibility in terms of applications, which in turn leads to lower cost for both the company and client. Electron beam technology also causes less material degradation compared to gamma radiation.

Our tour included a cool look at the electron beam generator and emitter (pictured), which is housed in the maze-like “shield”. Pretty cool stuff.

Precision Medical Technologies A Jet Tour of Northeast Indianas Medical Device HubNext, we traveled to Warsaw to visit Precision Medical Technologies, another contract manufacturer of orthopedic implants and surgical instruments. PMT has been extremely successful and is building another facility to handle their instrument manufacturing division in a neighboring county. Much of PMT’s success can be attributed to investing money in expensive, yet more sophisticated machinery that reduces the number of steps that it takes to manufacture a part, resulting in fewer variances and greater productivity. PMT also works very closely with local high schools and colleges to develop talented and experienced individuals to support the industry in the region.

Next was LH Medical, a division of LH Industries, which manufactures parts for a number of different types of businesses. Their medical division was started only about five years ago and has seen great success. Part of their vision is to manufacture all the parts that the other companies feel are too difficult or too low volume to manufacture. LH Medical also has its own team of design engineers to assist their clients in refining the design and manufacturing process.

Notre Dame Innovation Park A Jet Tour of Northeast Indianas Medical Device HubOur last stop was the campus of the University of Notre Dame to visit Innovation Park, an organization that provides facilities, funding, and other support for startups in life sciences and other industries. We had the opportunity to learn about some of the life science startups currently housed within their beautiful, new facility overlooking the Fighting Irish athletic complexes. CareX, founded by a Notre Dame management professor, is developing web-based point-of-care systems for physicians, caregivers, and extended/assisted living home nurses to track changes in their patients’ health. Altapure A Jet Tour of Northeast Indianas Medical Device Hub

Altapure, whose device we wrote about back in February, has developed a room/area sterilizer using ultrasonic technology to produce a highly dense cloud of liquid that can eliminate dangerous pathogens. F Cubed is developing and commercializing lab-on-chip technology to rapidly detect the DNA of dangerous bacteria in recreational and drinking water, food, and human fluid samples.

Overall, we got the sense that there’s a lot of innovation in the region, and we’re optimistic that, given the high rate of growth in the area, Northeast Indiana will join the ranks of the major medical hubs in the U.S.

Source : http://www.neindiana.com/

Full story

New VirtuoSaph Plus Vessel Harvester for Bypass Grafts

New VirtuoSaph Plus Vessel Harvester for Bypass Grafts

New VirtuoSaph Plus Vessel Harvester for Bypass Grafts

The VirtuoSaph® Plus Endoscopic Vessel Harvesting System delivers all of that with a new standard of care. It integrates key design functions with Terumo’s EVH knowledge and experience. All contribute to successful endoscopic vessel harvesting of the saphenous vein for coronary and peripheral artery bypass grafting. Details are in the brochure.

Supporting Research

Endoscopic vein harvesting is the standard of care in coronary artery bypass grafting but clinical studies describing the issues involved and comparing harvesting systems have been lacking until recently.

Read supporting research in these abstracts:

Rojas-Pena et al. Quantification of Thermal Spread and Burst Pressure After Endoscopic Vessel Harvesting (EVH): A Comparison of Two Commercially Available Devices. J. Thorac Cardiovasc Surg. 2011; 142: 203-208. Click here for a complimentary reprint.

Brown et al. Strategies to reduce intraluminal clot formation in endoscopically harvested saphenous veins. J Thorac Cardiovasc Surg 2007;134:1259-1265.

Burris et al. Incidence of residual clot strands in saphenous vein grafts after endoscopic harvest. Innovations: Technology & Techniques in Cardiothorac & Vasc Surg 2006;1(6):323-327.

Burris et al. Catheter-based infrared light scanner as a tool to assess conduit quality in coronary artery bypass surgery. J Thorac Cardiovasc Surg 2007;133:419-427.

Chiu et al. Reduction of carbon dioxide embolism for endoscopic saphenous vein harvesting. Ann Thorac Surg 2006;81:1697-1699.

Lin et al. Carbon dioxide embolism during endoscopic saphenous vein harvesting in coronary artery bypass surgery. J Thorac Cardiovasc Surg 2003;126:2011-2015.

In the good old days, babushkas going for a CABG (coronary artery bypass grafting) would expect to wake up with a big scar along the entire length of a thigh (or both). You see, deep veins of the thigh are harvested and used as grafts to bypass the cholesterol plug inside the coronary artery, and to supply the heart with blood (the “bypass” that everyone is talking about is a piece of the vein shunting blood from aorta to coronary artery, past the plug). The problem of the good old days was that big long scars would not heal, would get infected or would give much-too-much pain (“no pain, no gain” days).

Now things have changed. In today’s turbulent times, small incision is done, endoscopic camera is inserted and veins are harvested with the help of the endoscope, from the insides of the thigh. Here is a new system from Terumo Cardiovascular Systems, which has been announced yesterday:

ANN ARBOR, Mich., Jan. 20 /PRNewswire/ — Terumo Cardiovascular Systems Corporation has introduced the VirtuoSaph™ Endoscopic Vein Harvesting (EVH) System for use in coronary artery bypass grafting (CABG). The system is designed to enhance the precision and performance of clinicians interested in introducing this endoscopic procedure at their institutions. The new minimally invasive device provides an endoscopic approach to saphenous vein harvesting in which one small leg incision minimizes scarring, morbidity and infection associated with traditional longitudinal incisions.

Terumo Continues the Advancement of the Minimally Invasive Technique for Coronary and Peripheral Artery Bypass Grafting.

Terumo Cardiovascular Systems has announced the introduction of the VirtuoSaph(R) Plus Endoscopic Vessel Harvesting System following clearance by the U.S. Food and Drug Administration (FDA). The VirtuoSaph Plus system provides an endoscopic approach to vessel harvesting, and is used for coronary artery and peripheral artery bypass graft procedures. The system offers the cardiac surgery team a device that, when used in conjunction with the “Terumo Method” of vessel harvesting, consistently delivers bypass grafts with a new standard of care. (PRNewsFoto/Terumo Cardiovascular Systems)

Download image

ANN ARBOR, Mich., Sept. 12, 2012 /PRNewswire/ — Terumo Cardiovascular Systems has announced the introduction of the VirtuoSaph® Plus Endoscopic Vessel Harvesting System following clearance by the U.S. Food and Drug Administration (FDA).

(Photo: http://photos.prnewswire.com/prnh/20120912/DE70597)

The VirtuoSaph Plus system provides an endoscopic approach to vessel harvesting, and is used for coronary artery and peripheral artery bypass graft procedures. The system offers the cardiac surgery team a device that, when used in conjunction with the ‘Terumo Method’ of vessel harvesting, consistently delivers bypass grafts with a new standard of care. The Terumo Method, developed by Terumo’s team of engineers and dedicated Clinical Specialists, is a comprehensive set of guidelines designed to aid vessel harvesters in their pursuit of consistently high conduit quality.

Proven features retained from the original VirtuoSaph system include a completely integrated design, open CO2 insufflation and one step sealing and cutting capabilities. Key new features of the VirtuoSaph Plus system include:

Improved recyclable packaging features tray-in-tray design, offering easy access to the sterile tray and an ergonomic grip for better circulation of device

Patented PTFE dissector rod, designed to reduce the force required to create a tunnel and now with extended working length, allowing dissection of longer vessels

Precise control of spot cautery, with a safety switch available when needed

First of its kind integrated bipolar cord, minimizing the number of connections and improving electrical conductivity

Unique endoscope wiper now available on an all access 360 degree ring switch

“We find that use of the VirtuoSaph Plus system has given us an enhanced feeling of control. The longer PTFE dissector rod requires the use of less force and has reduced resistance during dissection. We also value the time that Terumo’s Clinical Specialists devoted to us and our CVOR team as we learned about the capabilities of this impressive new product,” said Timothy McCoy, PA-C, at The Toledo Hospital. He added, “Since we began using the VirtuoSaph Plus system we feel more confident that our team is providing our patients with high quality conduits that offer the patency our patients require for a positive outcome.”

Michael Moront, MD, also at The Toledo Hospital, agrees, adding “The improved ergonomics and well-engineered new design of the VirtuoSaph Plus system will result in improved conduit quality and better outcomes for our patients.”

About Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation manufactures and markets medical devices for the global cardiac surgery market and is the U.S. distributor for Vascutek® Vascular Grafts. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; and Ashland, Massachusetts. It is one of several subsidiaries of Terumo Corporation of Japan which focus on cardiac and vascular specialties, including Terumo Heart, Inc., developer of a ventricular assist device and Vascutek, Ltd., manufacturer of a broad portfolio of vascular grafts. For more information, visit www.terumo-cvs.com.

About Terumo Corporation

Tokyo-based Terumo Corporation is one of the world’s leading medical device manufacturers with $4.9 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the healthcare market and by responding to the needs of healthcare providers and the people they serve.

Source : http://www.prnewswire.com/news-releases/

www.virtuosaph-plus-endoscopic-vessel-harvesting-system-from-terumo-provides-cardiac-surgery-team-with-control-consistency-and-confidence-169440776.html

Full story

BIOTRONIK’s Lumax 740 ICD Debuts in the U.S.

BIOTRONIK’s Lumax 740 ICD Debuts in the U.S.

BIOTRONIK’s Lumax 740 ICD Debuts in the U.S.

To find what you’re looking for, try one of these options:

MarketWatch Front Page

A starting place for all your financial news and information needs.

Search

Search MarketWatch news, past and present.

Quotes

Get quotes for stocks, mutual funds, options and major market indexes.

More Effective Risk-Stratification for ICD Interventions Needed: BIOTRONIK PARCADIA Study Aims to Address Open Clinical Questions

BERLIN, Germany, August 31, 2012 — BIOTRONIK, a leading manufacturer of innovative medical technology, today announced the start of the prospective multicenter PARCADIA study. The study aims to identify risk factors that can help predict appropriate ICD (implantable cardioverter defibrillator) interventions in patients with ischemic cardiomyopathy who have received an ICD for primary prevention according to the current ESC (European Society of Cardiology) guidelines.

BERLIN, Germany, August 31, 2012 — BIOTRONIK, a leading manufacturer of innovative medical technology, today announced the start of the prospective multicenter PARCADIA study. The study aims to identify risk factors that can help predict appropriate ICD (implantable cardioverter defibrillator) interventions in patients with ischemic cardiomyopathy who have received an ICD for primary prevention according to the current ESC (European Society of Cardiology) guidelines. The first patient has now been enrolled in the Isala Clinics, Zwolle, the Netherlands.

“Findings from the MADIT-II trial showed that only one-quarter of patients who had a myocardial infarction and got an ICD for primary prevention received an adequate shock therapy,” explained Dr. Arif Elvan, Coordinating Clinical Investigator, Isala Clinics. “With the PARCADIA study, we want to assess if there are additional parameters that could help us to better predict who should get an ICD and who will benefit most.”

Current ESC guidelines indicate ICDs for primary prevention for patients who have a left ventricular ejection fraction (LVEF) of less than 35%. In addition to this, there is a need for a more effective risk-stratification method besides LVEF to identify patients that would benefit the most from an ICD.

“Most data regarding risk factors associated with appropriate ICD interventions comes from retrospective analysis of the major ICD trials with a primary goal of demonstrating ICD treatment survival benefit,” continued Dr. Elvan. “The PARCADIA study is designed to provide a clinical database to allow an explorative analysis of risk markers for more appropriate and effective ICD intervention.”

The primary objective of the PARCADIA study is to explore the potential of myocardial scar, assessed by MRI, as a predictor for appropriate ICD intervention. Myocardial scar is an important substrate for developing ventricular arrhythmias in ischemic cardiomyopathy. “Late Gadolinium Enhanced Cardiac MRI has a very high sensitivity to detect the amount of myocardial scar and might thus be useful in the prediction of future arrhythmic events,“ says Dr. Elvan. Secondary objectives are to identify baseline risk factors that could help to design a risk score system based on the MRI data, electrocardiographical (24-hour Holter ECG) and biochemical (blood analyses) information.

The PARCADIA study is a prospective, nonrandomized, multicenter clinical investigation of 200 eligible patients performed in four centers in the Netherlands. All patients in the study are identified with ischemic cardiomyopathy indicated for a “de novo” ICD implantation for primary prevention, according to European Society of Cardiology (ESC) guidelines or local standards. Patients will be analyzed in two groups: one receiving appropriate ICD intervention and the other without an appropriate ICD intervention during Follow-up. In the first group a higher burden of myocardial scar is expected. Final study results are expected in 2017.

“With our extensive clinical study program, BIOTRONIK consistently invests in research with the goal of discovering the best and most effective treatments. BIOTRONIK’s comprehensive portfolio of clinical trials supports our quality solutions and is aimed at making a real difference in advancing effective, efficient, comprehensive healthcare delivery. We address important unanswered clinical questions and have the potential to impact therapy guidelines,” commented Christoph Böhmer, President International of BIOTRONIK. “The PARCADIA study will help us define the best tools for predicting patients who would most benefit from receiving an ICD. Developing better, more accurate indication markers are in the best interests of patients, physicians and the health care system in general.”

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.

Source : http://www.biotronik.de/wps/wcm/connect/en_de_web/biotronik/home/

Full story

Disney’s Research Arm Develops Technology to Turn Any Surface Into a Touch Sensor

Disney’s Research Arm Develops Technology to Turn Any Surface Into a Touch Sensor

Disney’s Research Arm Develops Technology to Turn Any Surface Into a Touch Sensor

Touché is a new sensing technology that proposes a novel Swept Frequency Capacitive Sensing technique that can not only detect a touch event, but simultaneously recognize complex configurations of the human hands and body during touch interaction. This allows to significantly enhances touch interaction in a broad range of applications, from enhancing conventional touchscreens to designing interaction scenarios for unique use contexts and materials. For example, in our explorations we added complex touch and gesture sensitivity not only to computing devices and everyday objects, but also to the human body and liquids. Importantly, instrumenting objects and material with touch sensitivity is easy and straightforward: a single wire is sufficient to make objects and environments touch and gesture sensitive.

 

We demonstrate the rich capabilities of Touché with five example setups from different application domains and conduct experimental studies that show gesture classification accuracies of 99% are achievable with our technology.

We’re all fairly familiar with “Imagineering”, Disney‘s R&D branch that develops cutting-edge theme park technology and showcases the latest in moviemaking, but it’s a little known fact that the Mouse House also runs Disney Research, a group that develops technology that isn’t necessarily entertainment related.

Their latest bit of Disney magic is Touché, a technology that greatly enhances touch sensing capabilities making iPads and Androids already feel so 2012. Touché works by turning practically anything into a touch-sensitive interface, including the human body and liquids. All that’s required is a special electrode placed on the object, which in turn becomes a touch-sensitive surface, and a single wire connected to a computer. But Touché goes beyond creating touch-sensitive surfaces; multi-touch and gestures can also be used, which opens a lot of potential interactive applications.

Take a look at the video from Disney Research which demonstrates five scenarios in which Touché could someday be implemented. Some, such as the “human mp3 player,” seem more like novelty concepts. We’re particularly interested in the scenarios that detect posture. We (and Disney Research) think it could work great in a future “smart chair” that could detect an elderly or disabled person’s posture and remind them to change position or perform an action, or simply make the environment around them a little more comfortable.

Source : http://www.disneyresearch.com/research/projects/hci_touche_drp.htm

Full story

Scientists Discover that Lipids Control Proteins, Cell Membrane Curvature

Scientists Discover that Lipids Control Proteins, Cell Membrane Curvature

Scientists Discover that Lipids Control Proteins, Cell Membrane Curvature

In biological systems, membranes are as important as water. They form the barrier between the inner world, within our cells, where we perform the chemical reactions of life, and the outside environment.

But a biological membrane isn’t just a big container that keeps the world at bay, it is a vital, interactive gateway that sends and receives goods and messages in a highly regulated and specific way.

Membranes are known to perform their amazing functions through the interactions of proteins and lipids within the lipid bilayer.

Researchers who study membrane-driven processes such as synaptic communication, sperm-egg fusion, and viral infection have focused on the ways that proteins can regulate lipids to control membrane curvature to form the vesicles, pores, and tubules required for these processes.

Now, through advances in liquid surface x-ray scattering techniques at the X-ray Science Division 9-ID beamline at the U.S. Department of Energy Office of Science’s Advanced Photon Source at Argonne National Laboratory, Prof. David Gidalevitz and Dr. Andrey Ivankin from the Illinois Institute of Technology, and Dr. Ivan Kuzmenko from Argonne have discovered that lipids are also influencing the shapes of the proteins in the membrane and contributing to membrane curvature.

Their work, which promises to change the way researchers think about lipid-protein interactions and to open new avenues for the study of important membrane-driven processes, involved investigation of the interaction between a known membrane fusion protein, the HIV fusion protein, gp41, and artificially prepared lipid monolayers with various lipid compositions.

Gp41 is responsible for binding to host membranes and creating a pore through which viral RNA is inserted into the cell to propagate the virus. At the molecular level, this means that the viral protein must insert into the membrane and induce curvature in the membrane to make the pore. Careful measurement of the way the protein inserts into the lipid monolayer allowed the team to study how lipids and proteins affect each other during the insertion process.

Surprisingly, although the researchers expected gp41 to induce curvature in the lipid monolayer to form the pore, they found that experiments in which the monolayer contained more cholesterol showed that the lipids were actually affecting the structure of the protein. That is, as cholesterol concentrations increased, the area the protein occupied diminished and the ratio of lipids to proteins increased, suggesting that the protein was compacting itself differently as it inserted into the monolayer depending on its lipid composition.

The gp41 fragment that the team used has been shown to be capable of adopting one of two different structures known as ?-helix or ?-sheet. Their measurements are consistent with a change from the ?-helical to the ?-sheet structure as the cholesterol concentration increases, as shown in the figure.

The composition of the lipid monolayer also determined how deeply the protein penetrated its surface. In monolayers that completely lacked cholesterol, the protein penetrated very shallowly, however, as cholesterol increased, the depth that the protein inserted into the monolayer increased as well.

Remarkably, the free energy required for shallow insertion into the cholesterol-free membrane was the same as that for deep insertion into the cholesterol-rich membrane suggesting the structural change in the protein helped it to overcome the greater rigidity of the cholesterol-rich membrane.

“These data suggest that the cholesterol is inducing a conformational change in the protein and we think that when cholesterol is present, the fusion protein changes to form a sort of anchor in the membrane to hold the virus in place for fusion,” said Gidalevitz, lead author of the paper published in Physical Review Letters.

Next, the group hopes to extend these findings in experiments that will adapt their technique to more complex lipid bilayers with different lipid compositions and to different proteins including the islet amyloid-forming polypeptide amylin linked to Type 2 diabetes. “These membrane processes are critical to many basic biological functions,” said Gidalevitz. “Understanding them will help us to understand the biology underlying many important diseases.” — Sandy Field (sfield@fieldscientific.com)

See: Andrey Ivankin1, Ivan Kuzmenko2, and David Gidalevitz1*, “Cholesterol Mediates Membrane Curvature during Fusion Events,” Phys. Rev. Lett. 108, 238103 (2012). DOI:10.1103/PhysRevLett.108.238103

Author affiliations: 1Illinois Institute of Technology, 2Argonne National Laboratory

Correspondence: *gidalevitz@iit.edu

This research was supported by the NIH (R01AI073892) and DARPA (W911NF-09-1-378). Use of the Advanced Photon Source at Argonne National Laboratory was supported by the U.S. Department of Energy Office of Science under Contract No. DE-AC02-06CH11357.

The Advanced Photon Source at Argonne National Laboratory is one of five national synchrotron radiation light sources supported by the U.S. Department of Energy’s Office of Science to carry out applied and basic research to understand, predict, and ultimately control matter and energy at the electronic, atomic, and molecular levels, provide the foundations for new energy technologies, and support DOE missions in energy, environment, and national security. To learn more about the Office of Science x-ray user facilities, visit http://science.energy.gov/user-facilities/basic-energy-sciences/.

Argonne National Laboratory seeks solutions to pressing national problems in science and technology. The nation’s first national laboratory, Argonne conducts leading-edge basic and applied scientific research in virtually every scientific discipline. Argonne researchers work closely with researchers from hundreds of companies, universities, and federal, state and municipal agencies to help them solve their specific problems, advance America’s scientific leadership and prepare the nation for a better future. With employees from more than 60 nations, Argonne is managed by UChicago Argonne, LLC for the U.S. Department of Energy’s Office of Science.

Biomembranes undergo extensive shape changes as they perform vital cellular functions. The mechanisms by which lipids and proteins control membrane curvature remain unclear. We use x-ray reflectivity, grazing incidence x-ray diffraction, and epifluorescence microscopy to study binding of HIV-1 glycoprotein gp41’s membrane-bending domain to DPPC/cholesterol monolayers of various compositions at the air-liquid interface. The results offer a new insight into how membrane curvature could be regulated by cholesterol during fusion of the viral lipid envelope and the host cell membranes.

Our friend and an unofficial consultant to Medgadget on all things nanomedicine, Dr. David Gidalevitz was recently profiled by Illinois Institute of Technology Magazine. David is an IIT Coleman Faculty Scholar and Assistant Professor of Physics who does some amazing nano research with potentially huge clinical implications:

dd44332dds Nanowarrior David Gidalevitz is Fighting Antibiotic Resistance

Gidalevitz’s work involves the construction of membrane mimics, manmade nanostructures imitative of natural cell walls. He uses these mimics to better understand the precise mechanisms that allow AMPs to recognize and disrupt bacterial cell membranes, despite their structural variation.

Although some experimental drugs composed of naturally occurring AMPs have been attempted, such compounds are quickly recognized by proteases in the body and destroyed before they are able to act. On the other hand, ampetoids—mimics of natural AMPs—are different. “Antimicrobial peptide mimics won’t interfere with general biological systems,” Gidalevitz says. “They’re not recognized as such.”

To study the structure of membrane mimics and their interactions with AMPs, Gidalevitz takes a new approach, using sensitive technologies, including synchrotron-grazing incidence X-ray diffraction and X-ray reflexivity, in collaboration with Argonne National Laboratory. “To investigate the action of the peptides and membrane mimics with these techniques is fairly novel,” Gidalevitz notes. “These are definitely not tools used by a majority of biologists.”

Unlike natural cell walls, which are composed of a lipid bilayer, Gidalevitz’s membrane mimics are monolayer structures applied to an aqueous surface in which natural AMPs are dissolved.

Source : http://www.aps.anl.gov/Science/Highlights/Content/APS_SCIENCE_20120613.php

Full story

Hansen Medical’s Magellan Robotic System for Vascular Interventions Gets FDA Nod

Hansen Medical’s Magellan Robotic System for Vascular Interventions Gets FDA Nod

Hansen Medical’s Magellan Robotic System for Vascular Interventions Gets FDA Nod

Hansen Medical announced the world’s first use of the Magellan Robotic System in Peripheral Vascular Disease endovascular care. The device, covered before here at Medgadget, uses robotics to allow for more precise catheter delivery and guidewire manipulation in the endovascular treatment of peripheral vascular disease.

The ability to have accurate independent distal tip control of the sheath, catheter, and robotic manipulation of guidewires from a workstation will potentially allow for reduced procedure time, radiation exposure, and possible improved quality of treatment. This milestone first clinical case was performed at St. Mary’s Hospital in London (part of the Imperial College Healthcare).

MOUNTAIN VIEW, CA, Jun 04, 2012 (MARKETWIRE via COMTEX) — Hansen Medical, Inc. HNSN -0.68% , a global leader in intravascular robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Magellan(TM) Robotic System, including the catheter and accessories. The Company will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year. The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland from June 7-9.

The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The System has the potential to provide vascular surgeons and other interventionalists the ability to perform fast and predictable procedures, while allowing the physician to be seated comfortably away from the radiation source, which may reduce radiation exposure and physician fatigue.

“Today’s announcement marks one of the most significant milestones in the Company’s history,” said Hansen Medical President and CEO Bruce Barclay. “Not only does the Magellan System have the potential to be a significant growth driver for Hansen, it also represents a fundamental step forward in the transformation of vascular intervention using intravascular robotics.”

The global vascular market is large and expanding rapidly, driven by an aging population, the prevalence of diabetes and obesity, and an increase in disease awareness. Of the more than 3 million vascular procedures done worldwide each year, approximately one-third to one-half of them could be addressed using the Magellan Robotic System.

Dr. Alan Lumsden, Chair of Hansen Medical’s U.S. Scientific Advisory Board, and Chair of the Department of Cardiovascular Surgery and Medical Director of Methodist DeBakey Heart and Vascular Center at The Methodist Hospital, Houston, commented, “The Magellan Robotic System is a significant technological advancement that may offer important clinical benefits for physicians performing peripheral interventions. The System provides physicians with independent robotic control of both catheter tips to navigate efficiently through a variety of anatomies and lesions. Our in vitro and in vivo animal studies indicate that using this platform has the potential to increase efficiencies in the interventional lab by shortening procedure times and allowing more predictable interventions. Ultimately, we believe this System may facilitate alternative patient treatment options by enabling robotic endovascular interventions.”

The Magellan Robotic System results in a new standard for peripheral vascular intervention that has the potential to deliver revolutionary lesion access, precise distal tip control, solid catheter stability and consistent procedural efficiency.

Dr. Jean Bismuth, a leading vascular surgeon at the DeBakey Heart and Vascular Center at The Methodist Hospital, Houston, said, “Since the Magellan Robotic System was designed specifically for vascular interventions, it offers excellent catheter stability and precision during the delivery and placement of a variety of therapeutic devices in different anatomic conditions, including various peripheral vascular diseases with tortuous anatomy. Additionally, the Magellan Robotic System may offer physicians less radiation exposure and reduced procedural fatigue due to the remote workstation that allows the physician to be seated comfortably outside the imaging suite.”

The Company believes the Magellan platform also provides a compelling value proposition to hospitals.

“Hospitals today need to ensure not only quality patient care, but also sound fiduciary judgment in all purchase decisions,” continued Barclay. “To remain competitive in the markets they serve, hospitals need to become more efficient, while also increasing their patient capacity. The Magellan Robotic System has the potential to help hospitals accomplish both of these goals.”

“We are excited about the initial interest a number of key U.S. hospitals have shown in the Magellan System and intend to focus our near-term commercialization strategy on partnering with a select group of esteemed physicians who are both influential and early adopters of new technologies in the industry,” said Barclay. “We will provide them with the appropriate training and engage with them to demonstrate the benefit and value of the Magellan. This focused and controlled commercial launch should enable us to generate positive clinical experiences and data to drive both interest and adoption among other physicians and hospitals in the large and rapidly expanding U.S. peripheral vascular market, and will be followed later this year with full launch activities.”

Barclay concluded, “Today’s announcement is a testament to the immensely talented development and support teams at Hansen Medical that worked tirelessly to reach this important milestone, and I want to personally congratulate and thank them for their hard work.”

The Magellan System received a CE Mark in the European Union last year, and the Company has already commenced a commercial launch in that region. In addition, the System has been approved in Australia, and is pending approval in Canada.

About the Magellan(TM) Robotic System Hansen Medical’s Magellan Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X(R) Robotic Catheter System currently sold in the U.S. and Europe, which has been used in more than 8,000 patients, but includes a number of key enhancements. In particular, the Magellan Robotic System:

– Provides solid catheter stability for placement of therapeutic

devices.

– Is designed to enable predictable procedure times and increased case

throughput.

– Allows for independent, individual robotic control of the distal tips

of both the outer sheath and the inner leader catheter, as well as

robotic manipulation of standard guidewires.

– Is designed to allow for sufficient extension inside the body to

access hard to reach peripheral anatomy.

– Preserves the open architecture featured in the Sensei System to allow

for the subsequent use of many 6F therapeutic devices on the market

today.

– Is designed to potentially reduce physician radiation exposure and

fatigue by employing a remote physician workstation.

Hansen Medical Conference Call Company management will hold a conference call to discuss the receipt of 510(k) clearance for the Magellan Robotic System today, June 4, 2012, at 2:00 p.m. Pacific (5:00 p.m. Eastern). Investors are invited to listen to the call live via the Internet using the link available within the “Investor Relations” section of Hansen Medical’s website at http://www.hansenmedical.com/ . Additionally, participants can dial into the live conference call by calling 877-941-1427 or 480-629-9664. An audio replay of the webcast will be available approximately one hour after the completion of the conference call through June 11, 2012, by calling 877-870-5176 or 858-384-5517, and entering access code 4544736.

About Hansen Medical, Inc. Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company’s Sensei(R) X Robotic Catheter System and Artisan Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X System and Artisan Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established. In the European Union, the Sensei X System and Artisan Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx(R) Robotic Ablation Catheter is cleared for the treatment of AF. The Company’s Magellan(TM) Robotic System, NorthStar(TM) Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S.

Additional information can be found at www.hansenmedical.com .

Forward-Looking Statements This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “plan,” “expects,” “potential,” “believes,” goal,” “estimate,” and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the potential benefits of our Magellan Robotic System on the vascular procedures and the timing and results of commercializing our Magellan Robotic System. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses and obtain additional financing; and other risks more fully described in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May 7, 2012 and the risks discussed in our other reports filed with the SEC. Given these uncertainties, you should not place undue reliance on the forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart Design), and Sensei are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.

The FDA has given Hansen Medical (Mountain View, CA) the green light to bring the Magellan Robotic System domestically for peripheral vascular interventional procedures. It received European approval about a year ago and is already being used by clinicians.

The Magellan allows surgeons to remote control the distal tip of a catheter and a sheath from a workstation, offering potentially greater precision to surgeons and better outcomes with shorter procedure times for patients.

From the announcement:

The Company will commence commercialization at selected centers in the U.S. immediately, with a full launch expected later in the year. The product will be presented at the 66th Vascular Annual Meeting of the Society for Vascular Surgery at National Harbor, Maryland from June 7-9.

The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The System has the potential to provide vascular surgeons and other interventionalists the ability to perform fast and predictable procedures, while allowing the physician to be seated comfortably away from the radiation source, which may reduce radiation exposure and physician fatigue.

Source : http://www.marketwatch.com/story/

www.hansen-medical-receives-fda-510k-clearance-for-its-magellantm-robotic-system-for-peripheral-vascular-interventions-2012-06-04

Related Posts Plugin for WordPress, Blogger...

Full story

Page 1 of 612345...Last »
Copyright © 2017 Medical Technology & Gadgets Blog MedicalBuy.net. All rights reserved.
Proudly powered by WordPress. Developed by Deluxe Themes