Posts Tagged ‘treatment’

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University of Central Florida professor receives NIH’s New Innovator award

University of Central Florida professor receives NIH’s New Innovator award

The National Institutes of Health today awarded University of Central Florida Professor Ming Su its coveted New Innovator award, which comes with a $2 million grant.

The award recognizes visionary science that exhibits the potential to transform scientific fields and speed the translation of research into improved health, according to the NIH director’s office. Su’s research focuses on using nanoparticles to concentrate and precisely direct radiation energy to destroy cancerous tumors.

Su says nearly half of cancer patients receive radiation therapy at some point during treatment, but X-ray doses can damage normal tissue around the cancer. The idea of using nanoparticles to improve radiation therapy has been studied for the past several years as a way to enhance the potency of the cancer killing radiation, while limiting damage to surrounding healthy cells.

Because of the imprecise nature of radiation it is often used at lower dose than required, Su said. But that can lead to incomplete killing of cancer cells and recurrence of a tumor later.

Su will be using nanoparticles in way they have not been used before – so that radiation energy will be deposited preferentially to tumors.

“By doing so, the total X-ray dose required to kill the tumor will be reduced, and the damage to normal tissues will be minimized,” Su said.

The award is one of 10 Pioneer awards, 51 New Innovator awards, and 20 Transformative Research awards announced by the NIH today. The total funding is approximately $155 million.

Su, associate professor at UCF’s NanoScience Technology Center, is the only researcher from a Florida university to be selected and only one of 82 recipients nationwide announced today

The program funding all the projects, the High Risk Reward program, supports a series of exceptionally high-impact research programs that are broadly relevant to health and disease.

“The Common Fund High Risk High Reward program provides opportunities for innovative investigators in any area of health research to take risks when the potential impact in biomedical and behavioral science is high,” said NIH Director Dr. Francis S. Collins.

Source : http://www.news-medical.net/news/20120914/University-of-Central-Florida-professor-receives-NIHe28099s-New-Innovator-award.aspx

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SRS Endoscopic System for Gastroesophageal Reflux Disease Receives FDA Clearance

SRS Endoscopic System for Gastroesophageal Reflux Disease Receives FDA Clearance

SRS Endoscopic System for Gastroesophageal Reflux Disease Receives FDA Clearance

The SRS system by Medigus, offers endoluminal treatment for one of the most common chronic conditions

PR Newswire – Omer, Israel, May 24, 2012 – Medigus Ltd. (TASE: MDGS) announced that it has received FDA 510(k) marketing clearance for its SRS endoscopic system.

The SRS device is intended for minimally-invasive endoluminal treatment of GERD. The SRS endoscope is inserted into the esophagus through the mouth and does not entail incisions into the abdominal cavity. The endoscope contains a miniature video camera, ultrasonic sights, and a stapling device that enables the operator to perform partial fundoplication.

The device was cleared for marketing by the U.S. Food and Drug Administration in the 510(k) pathway, having successfully met safety and efficacy criteria during a multi-center clinical trial in five countries and three continents. In addition to the FDA clearance, Medigus already possesses a CE mark for the SRS system.

According to several sources, including the US Market for Gastrointestinal Endoscopic Devices 2011 & 2012, iData Research, the estimated potential market for endoscopic treatment of GERD in the United States is 33 billion US dollars, and the number of patients suffering from GERD among the global population ranges between 5%-17%.

GERD is caused by stomach acid or bile frequently flowing back into the esophagus. This irritates the esophagus, causing acid reflux, heartburn and other severe conditions.

About Medigus Ltd.

Medigus is a medical device company that specializes in developing innovative endoscopic procedures and devices. Medigus is a pioneer developer of a unique proprietary endoscopic device for the treatment of GERD. Medigus has an advanced technology platform that includes the necessary elements for developing a wide range of endoscopic procedures. The platform includes the smallest CCD and CMOS video cameras in the world, endoscopic staplers, ultrasound and endoscopy suites.

SRS Overview

Medigus has designed and created an entire endoscopic system for intra-luminal treatment of Gastroesophageal Reflux Disease (GERD).

Medigus’ SRS™ innovative endoscopy system for the treatment of GERD performs an anterior fundoplication in lieu of the current sugical procedure, but without opening the abdominal cavity. The SRS™ endoscopy system is CE marked and FDA cleared.

The SRS endoscope combines a surgical stapler, ultrasonic sights for accurate positioning and a miniaturized video camera in a single instrument – all of which are Medigus’ proprietary technologies.

The SRS endoscope contains all of the requisite tools to complete the entire procedure while it is controlled by the physician from the outside of the patient’s body with a unique, dedicated handle and control systems.

Globes [online] is reporting that Medigus Ltd., an Israeli company, which developed an endoscopy system for the treatment of gastroesophageal reflux disease (GERD), has filed for an IPO on the Tel Aviv Stock Exchange.

We, of course, have decided to follow up to find out how the system works. According to the manufacturer, the system’s crux is in the tip and the stapling cartridge:

The distal tip includes all the elements of a standard gastroscope and in addition includes the ultrasound measurement device, the anvil of the stapler and specialized screws for anchoring the scope while the procedure is performed. All this is included in a distal tip measuring only 15mm in diameter.

To perform the procedure:

1. The SRS endoscope is introduced into the stomach much like a standard gastroscope.

2. The operator selects a stapling site in the esophagus, 2.3 – 3.0 cm above the GE junction.

3. The operator inputs the distance from the incisors.

4. The endoscope is advanced into the stomach, and retroflexed to 180°.

5. It is then pulled back so that the cartridge is at the selected stapling site.

6. The endoscope is further flexed to 270°, until the tip is aligned with the cartridge.

7. The ultrasonic sight verifies that alignment is perfect and that the distance between the anvil and the tip is small enough.

8. The operator then cranks a flywheel which extrudes two tiny screws, which penetrate distal tip SRS System: Endoscopic Partial Anterior Fundoplicationthe tissue, and lock the anvil and cartridge together.

9. The staples are then fired, the screws are withdrawn, and the scope is extended, and withdrawn.

10. The SRS is reloaded with a new cartridge, and the procedure is repeated.

11. The final result is an antero-lateral wrap, which tapers from 120 to 180 degrees, and augments the angle of His.

Source : http://www.medigus.com/NEWS/2012/FDA/News.aspx

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U.S. FDA Clears Aero DR Wireless 17″ x 17″ Flat Panel Detector

U.S. FDA Clears Aero DR Wireless 17″ x 17″ Flat Panel Detector

Konica Minolta has received FDA clearance to market its Aero DR wireless flat panel radiography detector.  The 17 x 17 inch device weighs about 8 pounds (3.6 Kg).  The device is focused around a Cesium Iodide (CsI) scintillator that promises high detector quantum efficiency (DQE).aero

These detectors also take advantage of Konica Minolta’s very low power circuitry design which decrease read out noise and further raise quantum efficiency. All Aero DR systems deliver high image quality, reliability and easy workflow integration into general radiography environments.

Aero DR systems meet International Standards for both the 14 x 17 and 17 x 17 inch cassette sizes and therefore fit existing wall stands and bucky trays without modifications to help a facility maximize its investment in existing equipment and deliver a universal fit solution. Aero DR systems are offered in many configurations to meet both retrofit and new room purchase scenarios. A new Aero DR portable X-ray upgrade kit solution is also available to efficiently turn portable X-ray systems into digital, wireless solutions.

Wayne, NJ, February 14, 2012 – Konica Minolta announced today that the Aero DR Wireless 17 x 17 inch Flat Panel Detector (FPD) has received U.S. Food and Drug Administration (FDA) clearance. It is the world’s first, wireless 17 x 17 inch FPD weighing only 7.92 lbs.

The increased imaging area of the 17 x 17 inch Aero DR FPD improves clinical workflow and patient care by offering users more versatility in positioning patients and allowing for more clinical data on every exposure, which may decrease the number of exposures needed for studies that require imaging a larger region of interest. Aero DR detectors incorporate Konica Minolta’s own Cesium Iodide (CsI) scintillator that boasts ultra-high detector quantum efficiency (DQE). These detectors also take advantage of Konica Minolta’s very low power circuitry design which decrease read out noise and further raise quantum efficiency. All Aero DR systems deliver high image quality, reliability and easy workflow integration into general radiography environments.

“With the Aero DR, our customers are able to choose between wired and wireless operation. This allows greater flexibility to meet their imaging workflow needs.” says Darren Werner, Digital Products Marketing Manager. “This is the result of Konica Minolta’s dedication to delivering product advancements that contribute to improved patient care.”

Aero DR systems meet International Standards for both the 14 x 17 and 17 x 17 inch cassette sizes and therefore fit existing wall stands and bucky trays without modifications to help a facility maximize its investment in existing equipment and deliver a universal fit solution. Aero DR systems are offered in many configurations to meet both retrofit and new room purchase scenarios. A new Aero DR portable X-ray upgrade kit solution is also available to efficiently turn portable X-ray systems into digital, wireless solutions.

Konica Minolta Medical Imaging

Konica Minolta Medical Imaging is a leading manufacturer/distributor of digital and traditional imaging products for diagnostic use by hospitals, imaging centers, clinics and private practice physicians. Leading products include the REGIUS family of Digital Radiography systems, the Wireless Aero DR Solution, the ImagePilot CR featuring the Sigma Tabletop CR Solution, the DRYPRO family of laser imagers, medical, laser and specialty films and film processing equipment. For more information regarding Konica Minolta products and services, please visit medical.konicaminolta.us.

Source:http://www.konicaminolta.com/medicalusa/news/node_11287

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First-of-its-kind Head Patch Monitors Brain Blood Flow and Oxygen

First-of-its-kind Head Patch Monitors Brain Blood Flow and Oxygen

Researchers at Mayo Clinic in Florida have shown that cerebral optically-based near infra-red spectroscopic oximetry applied to patients who have suffered a stroke can help monitor regional cerebral perfusion in real time, and thus “may serve as a useful, noninvasive, bedside intensive care unit monitoring tool to assess brain oxygenation in a direct manner.” The study looked at the device called Fore-Sight from Casmed of Branford, CT, that measures blood oxygen, similar to a finger clip pulse oximeter. The Mayo study results have been published in Journal of Neurosurgery this month.

Regional cerebral blood flow monitoring devices such as Fore-Sight are already in wide deployment in cardiac surgery, where they are thought to prevent brain ischemia in patients undergoing major surgeries on bypass (valve replacements, aortic arch surgeries, etc.).

In the Fore-Sight device, the sensors stick on like adhesive bandages above each of the patient’s eyebrows. The technique, known as near-infrared spectroscopy (NIRS), emits near-infrared light that penetrates the scalp and underlying brain tissue. The Mayo Clinic team set up a study to compare measurements from NIRS with CT perfusion scanning in eight stroke patients.

More from William Freeman, neuro-critical care specialist and associate professor at Mayo Clinic, who was the senior investigator in this project:

About one-third of stroke patients in the hospital suffer another stroke, and we have few options for constantly monitoring patients for such recurrences. This was a small pilot study initiated at Mayo Clinic’s campus in Florida, but we plan to study this device more extensively and hope that this bedside tool offers significant benefit to patients by helping physicians detect strokes earlier and manage recovery better.

Currently, at most hospitals nurses monitor patients for new strokes and, if one is suspected, patients must be moved to a hospital’s radiology unit for a test known as a CT perfusion scan, which is the standard way to measure blood flow and oxygenation.

Although the results show that both tests offer statistically similar results, NIRS has a more limited field for measuring blood oxygen and flow. According to the researchers, this suggests that perhaps not all patients would benefit from this kind of monitoring.

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Successful Implantation of a Continuous-Flow Total Artificial Heart in a Patient at The Texas Heart Institute

Successful Implantation of a Continuous-Flow Total Artificial Heart in a Patient at The Texas Heart Institute

Drs. Billy Cohn and Bud Frazier at the Texas Heart Institute were faced with a patient last March who’s heart was about to succumb to the point that even a left ventricular assist device wouldn’t be sufficient to keep him alive. Described as a story of “two visionary doctors from the Texas Heart Institute who in March of 2011 successfully replaced a dying man’s heart with a ‘continuous flow’ rotor-driven device of their own design, proving that life was possible without a pulse or a heartbeat,” the film was directed by Jeremiah Zagar, whose feature-length documentary “In A Dream” was nominated for two Emmy’s in 2010.

HOUSTON, TX. (March 23, 2011) –  Doctors at the Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) have successfully implanted the first continuous-flow device that mimics what might be considered a total artificial heart in a desperately ill patient facing imminent death. Because the implanted pumps provide the blood flow that the sick heart cannot, they act as a total artificial heart.

On March 10, 2011, Drs. Bud Frazier and Billy Cohn implanted the 2 approved devices into 55-year-old Houstonian Craig A. Lewis. These devices were used in a last attempt to save his life.

Mr. Lewis had a rare condition called cardiac amyloidosis, a disease in which the heart is infiltrated by an abnormal protein produced elsewhere in the body. Patients with this affliction are not candidates for heart transplantation because the amyloidosis would probably recur in the transplanted heart.

The continuous-flow device consists of 2 turbine-like blood pumps implanted to replace the 2 sides of the patient’s removed heart. These 2 pumps act as a man-made substitute for the natural heart. The left ventricular assist devices (LVADs) used are manufactured by Thoratec Corporation (Pleasanton, Calif.) and were approved by the US Food and Drug Administration in January 2010 for assisting the failing left ventricle (the heart’s main pumping chamber) in patients suffering from terminal heart failure. The turbine pumps used in Mr. Lewis’s device were approved left ventricular assist devices that were modified for integration in a 2-pump system.  The devices were used in what is called an off-label use, that is, a use for something other than an originally intended indication. The FDA allows physicians to make decisions to use devices off-label in cases when they are clinically deemed the best therapy or, in this case, the only chance the patient has for meaningful survival. Mr. Lewis was not a candidate for an assist pump because his left ventricle was too badly involved with amyloidosis. His right ventricle had also failed.

Mr. Lewis had been supported by an external blood pump, a dialysis machine, and a breathing machine for 2 weeks before doctors decided to try this approach.

Because the device produces continuous flow, Mr. Lewis does not have a heartbeat, or a pulse. An EKG records no rhythm because the heart has been removed. Extensive research performed at the Cullen Cardiovascular Research Lab has shown that this unusual physiology is well tolerated by mammals. Based on their results over the last 5 years, Drs. Cohn and Frazier believed that this device was an option for Mr.Lewis. Less than one week after the device’s implantation, Mr. Lewis was able to sit up in bed and speak with family members.

The Texas Heart Institute has played a pivotal role in the development of implantable blood pumps to treat end-stage heart failure. Under Dr. Frazier’s leadership over the last 40 years, many of the devices currently in clinical trials were first tested and perfected at THI. The newer generation of continuous-flow, turbine-like pumps—first introduced 10 years ago—are smaller, quieter, and much more durable than their pulse-producing predecessors. These technically sophisticated pumps have accelerated the progress in the field of implantable devices. They also gave Frazier the idea for a continuous-flow total artificial heart. THI has been working on developing a continuous-flow total artificial heart over the last 5 years in collaboration with industry and funded by grants from the National Institutes of Health and the Dunn Foundation.

“This really is medical history in the making. The demonstration that one can support the human cardiovascular system with 2 implanted continuous-flow pumps is remarkable and very encouraging. With this new concept in cardiac replacement, we are much closer to realizing a meaningful off-the-shelf replacement,” said Dr. James T. Willerson, THI president. “The Texas Heart Institute is extremely proud of Drs. Bud Frazier and Billy Cohn and their entire team. This is an impressive step forward, following in the legacy of Dr. Denton Cooley, who in 1969 first implanted a prototype artificial heart in a human with a severe heart injury.”

Added Dr. Cooley, founder of THI: “Forty years ago the first total artificial heart was implanted here in a patient dying of advanced heart failure. The device served as a bridge to cardiac transplantation, maintaining the patient’s life until a donor heart was procured. Since then, a major focus of research at THI has been the development of a total mechanical heart that could overcome some of the problems presented by the previous pulsatile devices, including patient discomfort. The continuous-flow design of this device promises a major advance in the effort to replace the heart in patients with terminal cardiac failure. I applaud Dr. Frazier and Dr. Cohn for their contributions. This is a further milestone.”

Source:http://texasheart.org/AboutUs/News/2011-03-23news_tah.cfm

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InterVapor Endoscopic Thermal Ablative Treatment for Emphysema Gets CE Mark

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series C funding round, which will support commercialization of InterVapor for treatment of severe emphysema. This news comes on the heels of Uptake Medical receiving CE mark approval for InterVapor in September, completing the first commercial use of InterVapor in Germany in November, and recently announcing TGA approval for InterVapor to be marketed in Australia.

Steven Kesten, Chief Medical Officer at Uptake Medical, answered our questions about the company and its technology:

1.   How did the idea of InterVapor come about?

The idea for Uptake Medical’s InterVapor™ technology was based on the body’s healing response to thermal energy. Early research was based on the hypothesis that if we were able to trigger a temporary Localized Inflammatory Response (LIR) that the associated healing process would ultimately develop a scar that would remodel and reduce the diseased lung tissue. Early experiments were conducted using various forms of heat energy, such as radio frequency, but the energy could not travel out to the diseased areas of the lung due to a lack of available lung mass. Experimentation ultimately lead to the discovery that heated water vapor (steam) was the optimal form of heat energy as it is in gas form and could easily travel through the airways to the diseased parenchyma. The development team made a prototype, proved the theory with ex-vivo animal lungs and this is the basic theory which has been ultimately proven in both animal and human clinical studies.

2.   Can you describe the process of delivering the heated vapor to the diseased lung?

In advance of the InterVapor procedure, a personalized treatment plan is developed specifically for the patient to be treated. A high-resolution CT of the patient’s lungs is analyzed by the Uptake Medical core lab. This analysis includes a quantitative assessment of several factors to determine the degree of heterogeneity and to identify the lung regions where the best opportunity for lung volume reduction may be successfully achieved. These recommendations are forwarded to the treating pulmonologist as an InterVapor Personalized Procedure Program™ (IP3™).

For the procedure itself, a bronchoscope is inserted into the lungs and the physician, following the blue print provided by the IP3, reviews the patient’s lungs and determines the course of treatment. The InterVapor Catheter is inserted through the working channel of the bronchoscope into the targeted airway. The treatment time specific to the target airway is obtained from the IP3 and keyed into the InterVapor Generator. This airway is briefly occluded by the inflation of a balloon at the end of a catheter and a dose of heated water vapor is delivered to the lung tissue. The balloon is then deflated, the catheter is removed and additional airways are treated as appropriate. The entire procedure, on average, takes 30 minutes.

InterVapor Mechanism of Action:

Treatment: The delivery of heated water vapor triggers a temporary Localized Inflammatory Response (LIR) which sets the body’s natural healing process in motion.

Healing: This LIR is usually resolved within 4-12 weeks as the lung begins the healing and remodeling process.

Response: InterVapor has been shown to lead to clinical improvements in lung function, exercise capacity and health-related quality of life.

3.   What meaningful clinical improvement above and beyond medical therapy can we expect with InterVapor, especially in terms of exercise function and quality-of-life?

In the VAPOR trial patients received optimal medical management prior to treatment with InterVapor. InterVapor therapy resulted in clinically relevant improvements in lung function, quality of life and exercise tolerance in upper lobe predominant emphysema. At 6 months, airflow as assessed by FEV1, FEV1 improved by 141 ml, air trapping as assessed by residual volume (RV) was reduced by 406ml. Health-related quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ) total score improved by 14.0 units with a 4 unit improvement having been reported as the minimal clinically important difference. Exercise capacity, as assessed by the 6-minute walk test, improved by 46.5 m and breathlessness, as measured by the modified Medical Research Council (mMRC) dyspnea scale improved by 0.9 units. All of the above endpoints were associated with p values less than 0.05. The results were clinically and statistically significant.

The results of the VAPOR trial are available online, ahead of publication, in the European Respiratory Journal. (Snell, G., et al. Bronchoscopic Thermal Vapor Ablation Therapy in the Management of Heterogeneous Emphysema. Eur Respir J 2012; DOI 10.1183/09031936.00092411)

4.   Is this a one-time procedure or can this be repeated multiple times to different diseases segments of the lungs?

The InterVapor System is intended for use in patients with heterogeneous severe emphysema to achieve bronchoscopic upper lobe lung volume reduction by the application of heated water vapor to the lung segments targeted for treatment. The clinical results observed in the VAPOR trial were achieved as a single, unilateral procedure. In a typical InterVapor treatment, 3-8 airways within a lung are treated.

5.   Where is InterVapor therapy currently available? Is it available in any capacity in the United States?

Uptake Medical has received the CE mark and TGA approval for InterVapor and we are focusing our commercial efforts in both Germany and Australia at this time. We plan to extend our commercialization throughout Europe during 2012. At this time InterVapor is not available in the US.

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Roswell Park Launches Landmark Immunotherapy Vaccine Trial

Roswell Park Launches Landmark Immunotherapy Vaccine Trial

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) is about to begin a very exciting new cancer clinical trial that will test a personalized immunotherapy to attack cancer cells.

The new NY-ESO-1 dendritic cell vaccine will be produced “using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study,” according to the announcement.

The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

PLEASE NOTE: As expected, Roswell Park Cancer Institute continues to receive a very high volume of calls and emails from patients and their families regarding the vaccine clinical research study that was announced at our press conference, January 24. Many calls and emails (and even some in-person inquiries) are coming into all sectors of the Institute – from the clinics and Switchboard to Patient Access and the Cancer Resource Center. The staff and faculty of Roswell Park are making every effort to ensure that you receive the information you need quickly and efficiently. Therefore, we ask that you ONLY contact the ASK-RPCI information center. To reach the ASK-RPCI information center, call 1-877-ASK-RPCI (1-877-275-7724), Monday through Friday, from 9 a.m. until 5:30 p.m. or send an email to askrpci@roswellpark.org. Information about the trial is also included on the Roswell Park website at www.roswellpark.org. Thank you for both your cooperation and your interest in this important new study.

Dendritic cells are the gatekeepers of the human immune system, defending against invaders like bacteria, viruses and cancer. The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology. Last year, the FDA approved the first therapeutic cancer vaccine, Provenge® (sipuleucel-T), for men with advanced prostate cancer. RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma (a type of brain tumor) and another vaccine for patients with ovarian, fallopian tube, and primary peritoneal cancer.

“This trial will be only the beginning of a very robust program of activity in the area of using the human immune system to fight cancer,” adds Dr. Odunsi. “Our production process holds tremendous potential for applications related to stem-cell therapy and regenerative medicine, and I believe we’re uniquely positioned at RPCI to have the tools, infrastructure and multidisciplinary collaboration to capitalize on these ideas and opportunities both effectively and efficiently.”

The clinical research study will enroll 18-20 eligible patients whose tumors express a specific antigen, known as NY-ESO-1. Apart from the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body, but is expressed in cancers. This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

Dr. Odunsi, who developed the NY-ESO-1 vaccine, led previous trials evaluating its effectiveness in treating ovarian cancer. Christine Sable of Lancaster, Pennsylvania, enrolled on one of those studies in February of 2004, after undergoing surgery and chemotherapy for advanced-stage ovarian cancer. Although she faced a 75-80% chance that the cancer would return, her immune system responded strongly to the vaccine, and she has remained cancer-free in the seven years since then, with no side effects.

Source:http://www.roswellpark.org/media/news/roswell-park-launches-landmark-immunotherapy-vaccine-trial

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Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability.

The company already has approval from the FDA to market the Cardius X-ACT in the U.S.

POWAY, CA – (MARKET WIRE) – 01/25/12 – Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union. The Cardius X-ACT imaging system was designed to increase diagnostic accuracy and make earlier detection of disease possible.

Digirad also announced that it had begun to strategically build out a targeted international selling network by signing a distribution agreement with Epsilon Elektronik in Turkey, a part of the Istanbul-basedBozlu Group. Last year, Digirad signed a similar agreement with UK-based Southern Scientific, which has already placed an ergo™ portable solid-state camera at the Manchester Royal Infirmary where it is being used in a number of general and surgical imaging settings.

“One of the legs of our transition to growth in the product category is to build a targeted network of top distributors in key international markets that have a growing demand for flexible, high-quality imaging products such as the X-ACT. Our experience and the data indicate that price point, flexibility and potential for better clinical outcomes at lower overall costs are key elements to healthcare buying decisions, and our growing line of camera products uniquely fits those requirements,” said Digirad CEO Todd P. Clyde. “It is our intention, as one of several new initiatives in 2012, to more aggressively build a distribution network to tap the developing markets for dedicated cardiac and portable nuclear imaging in a more meaningful way. To that end, gaining of CE Mark and additional distribution agreements are key initial elements of that process.”

The Cardius X-ACT imaging system features a low-dose volume-computed tomography attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues.

“We believe our Cardius X-ACT imaging system, our ergo flexible imaging camera and future camera models will be well-received internationally because of their accuracy, diagnostic benefits and economic models that fit well with healthcare spending. They all provide new clinical information that increases the benefit of nuclear cardiology procedures. That increase in diagnostic confidence can improve outcomes and raise the standard in the industry internationally for SPECT system performance at a price point that is accessible in many countries,” added Clyde.

Digirad has previously received clearance from the FDA to market the Cardius X-ACT imaging system in the U.S. and has garnered both CE Mark and FDA clearance to market its ergo portable solid-state camera.

About Digirad Corporation
Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit www.digirad.com. Digirad® and Cardius® are registered trademarks of Digirad Corporation.

Source:http://drad.client.shareholder.com/releasedetail.cfm?ReleaseID=642105

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Innovative Study of High Blood Pressure

Innovative Study of High Blood Pressure

The FDA has conditionally approved an investigational device exemption (IDE) for a pivotal clinical trial to evaluate a new patented isometric handgrip therapy technology. A product of Zona Health(Boise, ID), the ZonaRx device was developed for use in the treatment ofresistant hypertension (high blood pressure that persists despite treatment by two or more medications). The IDE approval marks the first pivotal trial of isometric handgrip therapy for hypertension treatment.

Earlier clinical studies demonstrate that the isometric handgrip therapy could provide “a significant reduction in blood pressure levels for the majority of hypertensive patients,” according to Zona Health. According to earlier data, 135 out of 136 study participants achieved significant blood pressure drops in eight weeks or less.

From the announcement:

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

BOISE– 1/18/2012 – Zona Health, developer of non-invasive, non-drug treatments for hypertension, announced that the U.S. Food and Drug Administration (FDA) conditionally approved an Investigational Device Exemption (IDE) for a pivotal clinical trial to evaluate the Company’s patented isometric handgrip therapy technology (ZonaRx™) for use in the treatment of resistant hypertension (high blood pressure in the presence of two or more medications), an especially dangerous disease affecting hundreds of millions of people worldwide. FDA approval of the IDE makes Zona Health’s study the first pivotal trial of isometric handgrip therapy for hypertension treatment.

The investigatory team for the study includes JoAnn Lindenfeld, M.D., Director of the Cardiac Transplant Program at University Hospital in Aurora, Colorado, and a member of the FDA Devices Committee; Suzanne Oparil, M.D., Professor of Medicine and Director of the Vascular Biology and Hypertension Program in the Division of Cardiovascular Disease at the University of Alabama at Birmingham, and Co-chair of The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8); and Kenneth Kronhaus, M.D., Ph.D., Cardiologist, and American Heart Association Spokesman.

“We are very pleased with the IDE approval and look forward to commencing the pivotal study to provide longer term safety and efficacy data of our ZonaRx™ hypertension treatment technology in this set of resistant hypertensive patients,” said Steven Wood, President and CEO of Zona Health. “We believe this innovative treatment has the potential to provide patients with an effective way to control their blood pressure when other treatment options are insufficient.”

The pivotal trial is a double-blind, randomized, controlled study designed to evaluate the safety and effectiveness of isometric handgrip therapy with the ZonaRx™ in patients who are taking two or more medications but cannot reach their blood pressure goals. The study will enroll approximately 200 patients in several medical centers across the U.S.

The ZonaRx™ is a medical device which enables patients to easily perform isometric handgrip therapy in the comfort of their homes. The device uses patented technology to accurately customize the therapy for each individual patient in order to trigger a specific physiological response that leads to lower blood pressure. The ZonaRx does not require a permanent implant or invasive surgery.

Clinical research shows that Zona Health’s isometric handgrip therapy may provide a significant reduction in blood pressure levels for the majority of hypertensive patients. Across several earlier studies, 135 out of 136 participants achieved significant blood pressure drops in eight weeks or less.

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. High blood pressure is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are sometimes not effective for all patients. As a result, despite lifestyle changes and the availability of modern antihypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled, and approximately 15-20 percent of those are resistant.

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TLT announces yet another blood pressure breakthrough from its Sapphire programme

TLT announces yet another blood pressure breakthrough from its Sapphire programme

Tarilian Laser Technologies, a Hertfordshire, UK firm claims it has developed the “greatest technological advance in blood pressure measurement for 130 years”  Unlike direct pressure measurement that every other BP meter does, the company’s Sapphire device uses an optical sensor to continuously measure blood pressure at the wrist. Keeping the Sapphire stationary will provide beat-to-beat readings and Tarilian says the device can effectively be used to detect white coat hypertension (raised blood pressure due to patient being in a clinical setting).

The company believes this technology can be translated for non-contact measurement of intraocular pressure, fetal heart monitoring, and for blood pressure monitoring using small mobile devices at different spots on the body.

A cuffless device that delivers a high fidelity signal from which accurate and powerful haemodynamic biometric readings can be made.

  • An sensor that delivers results within nanoseconds – The TLT device delivers a continuous blood pressure within nanoseconds of being applied to the body
  • No energy enters the body and there is no need for calibration
  • Can be applied anywhere on the body; the neck, the eye, arms and legs etc ( we have even successfully developed an eye blood pressure monitor for example!)
  • A continuous monitor that generates a unique waveform
  • Beat-to-beat BP monitoring: generates a blood pressure every heart beat
  • Carotid artery beat-to-beat BP monitoring
  • Can even measure blood pressure directly in the eye
  • Averaged BP monitoring (so the user can see a single SBP and DBP which can be updated every 5 heart beats)
  • blood flow monitoring
  • and also heart monitoring irregularities of the ventricles: can detect ventricular heart beat irregularities

Optoelectronic sensor can detect white coat hypertension and blood pressure variability

20 December 2011. Welwyn Garden City, UK. – Tarilian Laser Technologies (TLT) have confirmed, from early studies, the ability of its Sapphire sensor technology to detect white coat hypertension (WCH) during measurement of blood pressure in a clinical setting and to create a novel platform from which WCH can be distinguished from background stress and anomalous baseline variability.

White coat hypertension, which is commonly called white coat syndrome, is the term used to describe the raised blood pressure shown by patients when their blood pressure is measured in a clinical setting that is not shown elsewhere, such as at home. This raised pressure is significant for medical diagnosis as it may lead to inappropriate management of the hypertensive patient — which increases risk, distress and costs to the healthcare system.

Commenting on this new discovery, Dr Sandeep Shah, CEO of TLT stated: “Yet again we are uncovering new capabilities of our optoelectronic blood pressure sensor and the very rich signal that it generates. This new pivotal development further distinguishes the TLT technology from other technologies on the market in that we can further validate potential false positives within the clinical process and avoid the situation where the patient receives unnecessary treatments.”

Variability in baseline blood pressure

Blood pressure can sometimes fluctuate in humans as a result of a complex interactions between external stimuli and the response of cardiovascular control mechanisms in the body. This is now suspected to be an important factor to measure and where possible to try and control. Blood pressure variability is mainly detected using 24-hour ambulatory blood pressure monitoring – ie using cumbersome and often inaccurate oscillometric measurements.

The TLT Sapphire sensor now offers a new powerful dynamic in that it can accurately and directly determine beat-to-beat blood pressure using an optical microsensor that is very small, innocuous and comfortable to wear, avoiding the discomfort of the current systems.
Until a few years ago, the variability in blood pressure had been dismissed as a ‘background noise’ that dilutes the prognostic effects of average blood pressure. Recent research now indicates that blood pressure variability is in itself an important phenomenon to track and control as it is associated with morbidity and mortality.

Blood pressure variability is an important risk factor for stroke and this is substantiated by evidence from various clinical trials around the world. Systolic blood pressure varies to a greater degree than diastolic blood pressure. Early death or neurologic deterioration, and recurrent stroke are associated independently with high systolic blood pressure, mean arterial pressure, pulse pressure, and blood pressure variability.

Commenting on this new development, TLT CEO Dr Sandeep Shah stated: “ At TLT, we are excited by the further progression of our understanding of how the TLT Sapphire waveform — which with its high fidelity and rich data — can give a better and more accurate assessment of blood pressure variability. Blood pressure variability is something that has become a key topic for discussion at several major international medical conferences. Having the robust non-invasive TLT sensor that can directly monitor beat-to-beat blood pressure variability allows us to uncover even more useful information that will help us to protect the patient further. Within the next few weeks, we now expect to develop a new Sapphire sensor platform focussed on detailed beat-to-beat analysis and thus open up a paradigm for the utility of the TLT sensor around the world.”

About Tarilian Laser Technologies
Tarilian Laser Technologies (TLT) was established in 2006 by Dr Sandeep Shah, CEO, and Nita Shah, Programme Director, to further develop optical technology that they had discovered could measure blood pressure in a unique way. Following completion of the research programme the company filed a series of patents and set up an international R&D team to progress with the development of the sensor technology. TLT has already successfully completed its international FDA and MHRA pivotal regulatory clinical trial, working with global experts in clinical medicine and clinical trials, including from Barts Hospital, London and the William Harvey Institute, London. TLT is now completing the manufacturing scale-up and translation programme for its first product — a highly innovative consumer blood pressure device that is cuff-based and has unique features including superior accuracy and ease of use. TLT expects that its Homecare division will enter significant sales revenue by 2012. It has already secured advanced sales interest in this device, with first year volumes expected to reach about 1 million units.

Source:http://www.tarilian-lasertechnologies.com/press/pr111203.htm

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