A CD&D

There may be a new way to improve survival and recovery rate after a heart attack, according to a report in the June issue of Stem Cell Research by scientists at the Institute of Medical Biology (IMB; Singapore) and Bioprocessing Technology Institute (BTI; also Singapore) and University Medical Center Utrecht in the Netherlands. The method, developed in laboratory research with pigs, is the first non-cell based therapeutic application of human embryonic stem cells, according to the scientists. It entails using secretions from stem cells.

In their studies with pigs, the researchers found that the administration of secretion from stem cells minimized heart injury by enhancing reperfusion therapy (angioplasty and cardiac bypass surgery) and reducing tissue death by another 60%. Heart function was also markedly improved, the scientists report in the paper.

By demonstrating the efficacy of this secretion in an experimental pig model, currently the best approximation to a human heart attack patient undergoing reperfusion therapy, the researchers say that they have addressed the longstanding problem of reperfusion injury in the most clinically relevant experimental setting.

"Using secretion instead of cells allows us to circumvent many highly intractable problems such as tumor formation, immune compatibility, cell viability, delivery, costs and timeliness," said IMB's Dr Lim Sai Kiang, who leads the collaboration.

Unlike the more common approach of directly administering stem cells for therapy, this new method carries negligible risk of tumor formation or rejection by the body, according to the report. In the pig research model, this approach minimized heart injury after a heart attack. The research was carried out on pigs because it is the closest animal approximation to the human heart in terms of size, structure and function, the researchers noted.

The scientists say the findings are important because they show that the new method can overcome the unwanted side effects of reperfusion, currently the best therapeutic option available to heart attack patients. Reperfusion is the restoration of blood flow to the oxygen-deprived heart after a heart attack.

"This is a major discovery of clinical significance. There are some problems and issues associated with the use of stem cells to treat heart attacks and blocked arteries in the heart, and with this new method, many of these issues are removed. Potentially, we may have an important way to treat heart attacks. More tests will need to be done and human trials planned," said advisor to the Singapore researchers, Lee Chuen-Neng, MD, who heads National University Hospital of Singapore's Department of Cardiac, Thoracic and Vascular Surgery. He also is chair of surgery at the National University Health System.

Tepnel launches DNA test for FH

Tepnel Life Sciences (Manchester, UK/Stamford, Connecticut) reported the launch of a DNA test for the early detection of familial hypercholesterolemia (FH), a genetic condition that predisposes individuals to high blood cholesterol levels and increased risk of cardiovascular disease.

The CE-marked Elucigene FH20 kit, validated for in vitro diagnostic use, can rapidly determine the 20 genetic mutations most commonly found in a UK-based population, that are responsible for the disease.

The company said the launch comes just prior to the expected release of clinical practice guidelines on familial hypercholesterolemia by the UK's National Institute for Clinical Excellence (NICE).

Tepnel said FH is a public health problem throughout the world, with an estimated 10 million people affected, the majority of who will suffer an adverse coronary event before they are 65 years old.

A common genetic disorder, the potentially lethal condition occurs in one of 500 people in Europe and North America. In the UK, it is estimated that up to 110,000 people are affected with FH and 75% of these cases are undiagnosed.

The NICE consultation on a draft of guidelines for use by the National Health Service in England and Wales is being finalized, with anticipated publication shortly. NICE is expected to recommend that all FH patients be offered a DNA test, with subsequent cascade screening to be performed where the mutation is identified in a patient. Following the confirmation of mutation status of an FH patient using the Elucigene FH20 assay, the Tepnel test can be used to detect other previously undiagnosed family members with FH through cascade screening programs.

In a recent UK pilot study, the test identified a 52% mutation detection rate in a sample of 110 FH heterozygous patients. "The study findings validate Elucigene FH20 as a valuable component for future FH screening programs in the United Kingdom, providing a cost-efficient and simple method for confirming a person has inherited this deadly condition," said Tepnel CEO Ben Matzilevich. "For effective treatment, early identification of persons with FH is essential and FH20 offers the NHS the right tool at the right time to implement the new clinical practice guidelines."

The company said that pre-symptomatic identification of FH individuals "can ensure the health risks of high cholesterol are minimized through appropriate modifications to diet and lifestyle."

Six-month data show gains with CardioFit

BioControl Medical (Yehud, Israel) last month reported the publication of six-month data for eight of the more than 30 patients who participated in the European pilot study of its CardioFit device for congestive heart failure (CHF).

All eight patients were enrolled at the Fondazione IRCCS Policlinico San Matteo and the University of Pavia in Italy. The results were published in the September issue of the European Journal of Heart Failure.

The article was authored by the study's principal investigator, Peter Schwartz, MD, along with his research associates. The article, titled "Long-Term Vagal Stimulatyion in Patients with Advanced Heart Failure-First Experience in Man," describes the use of CardioFit's implantable vagal stimulation system in a pilot study designed to assess, for the first time ever, the feasibility and safety and possible efficacy of chronic vagal stimulation in CHF patients.

"A significant 40% improvement was observed in the commonly used Minnesota Living with Heart Failure Quality of Life questionnaire and in left ventricular end-systolic volume," Schwartz said. A favorable trend toward reduction was also observed in end-diastolic volume [and] despite their difficult baseline condition, the patients' NYHA functional class improved significantly."

The eight patients, all with advanced CHF, had a mean age of 54 years. Two to four weeks after implantation of CardioFit, vagal stimulation was initiated and intensity increased according to a prospective protocol. "It is our opinion as investigators that the CardioFit's novel approach to the treatment of patients with heart failure is feasible, and appears safe and tolerable," Schwartz said. "The preliminary efficacy results support the commencement of a controlled multi-center study in a larger population to confirm the seeming efficacy of the system."

"[Our] implantable neuromodulation technology has a wide range of applications," said Dr. Ehud Cohen, CEO of BioControl Medical. "To date, it is being applied to develop therapeutic devices in urology and for the treatment of congestive heart failure. In parallel with the development of these products, the company is also investigating applications for other indications."

He added, "The main focus of the company today is the initiation of an international, multi-center, pivotal study of the CardioFit system, which we believe will likely make a significant impact on existing clinical protocols once approved in the U.S. and Europe."

The company said details pertaining to the six-month data on the first 20 patients in the pilot study will be addressed in a presentation at the American Heart Association's (Dallas) annual scientific sessions in New Orleans in November.

Hansen reports use of Sensei for AAA repair

Hansen Medical (Mountain View, California), a developer of flexible robotics and robotic technology for accurate 3-D control of catheter movement, reported that a team of physicians led by Professor Nick Cheshire at St. Mary's Hospital (London), part of the Imperial College Healthcare NHS Trust in London, used its Sensei robotic catheter system and Artisan control catheter to aid deployment of stent grafts used to treat an abdominal aortic aneurysm in a 78-year old patient.

The company said it believes this is the world's first procedure in which any robotic medical technology has been used to repair an aortic aneurysm through a patient's vascular system.
"We have always believed vascular surgery would provide a very natural application for our Sensei and Artisan robotic technology, and the recent advancement at St. Mary's Hospital demonstrates what is already within reach for our technology in this field," said Fred Moll, MD, co-founder and CEO of Hansen. "Just as important, the recent experience of clinicians at St. Mary's Hospital clearly demonstrates what physicians can accomplish when they use Hansen Medical's advanced technology to provide more precise movement and control during different types of surgery."

"The time taken to correctly position a stent graft during the treatment of an aneurysm is highly variable and depends on the complexity of the vascular anatomy," explained Professor Nick Cheshire. "By providing increased catheter stability and accurate navigation, the Sensei system has the potential to greatly simplify the procedure and make it more predictable. In this case, it only took a few minutes to drive the Artisan catheter to the location where the stent was to be deployed."

An abdominal aortic aneurysm results from weakening and swelling of the artery's walls, often as people age, and is frequently fatal if it ruptures. When positioned across the weakened section, stent grafts act as scaffolding that can help prevent the aneurysm from bursting. This surgery was performed through accessing the patient's vascular system at the groin and using Hansen Medical's Sensei system to accurately navigate the Artisan catheter up into the weakened section of the aorta, where the stent grafts were placed.

French distributor for Hemotase MPH

CryoLife (Kennesaw, Georgia), a biomaterials, medical device and tissue processing company, reported that it has begun distribution in France, through Laboratoire Gamida, of Hemostase MPH for use in general, cardiac and vascular surgery.

CryoLife began distributing Hemostase MPH in the U.S., the UK and Germany in the 2Q08, and distribution in other markets is planned for later in 2008 and in 2009.

Hemostase MPH is developed using CryoLife's Microporous Polysaccharide Hemospheres technology (MPH), which yields a plant-based powder engineered to rapidly dehydrate blood, enhancing clotting on contact. This hemostatic agent facilitates the formation of a resilient, natural clot within just a few minutes.

Hemostase MPH received CE-mark approval in 2003 and FDA approval in September 2006.

Unlike many hemostatic agents, Hemostase MPH does not require additional operating room preparation or special storage conditions.

The company said pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24 to 48 hours of application at the wound site, compared to other surgical hemostats that can take three to eight weeks or more to fully break down.

"As a complement to CryoLife's BioGlue product line, Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, and we are pleased to begin offering this product in France," said Steven Anderson, president/CEO.

Stereotaxis reports catheter use reintroduced

Stereotaxis (St. Louis) reported that the first atrial fibrillation (AF) procedures using its re-introduced partnered magnetic irrigated catheter were successfully performed in Europe last week.

The catheter received CE-mark approval in the last week of August following its resubmission to European regulators by the company's partner in July, and these first cases are part of the standard pre-release evaluation.

Also in July, the company's partner submitted a PMA supplement to the FDA for use of the magnetic catheter in the U.S. with the expectation that U.S. approval would be obtained subsequent to the CE mark.

Carlo Pappone MD, PhD, performed the first procedures last month at San Raffaele University Hospital (Milan, Italy).

Pappone said he was "delighted with the results of my first procedures performed successfully with the newly available Biosense magnetic irrigated catheter. I am extremely happy with its performance, and believe that Biosense did an excellent job. Contact stability, lesion quality and overall mechanical performance are excellent, and I believe safety is likely to be exemplary."

Bevil Hogg, CEO of Stereotaxis, said, "We are very pleased with the successful initial experience of our partnered magnetic catheter following its recent re-introduction in Europe. Most importantly, we anticipate that the commercial re-introduction of this catheter, which is used primarily for complex procedures in the left atrium of the heart, will mark a point of inflection in the utilization of our installed base of Niobe systems, resulting in a substantial increase in procedure volume over time and a concomitant acceleration of system sales."

Israel's Hadasit tests double lumen catheter

Hadasit (Ein Kerem, Israel) reported the successful pre-clinical testing of a prototype of the Double Lumen PCI Guiding Catheter for use in the treatment of coronary artery disease.

Unlike conventional catheters, the Double Lumen PCI Guiding Catheter has two lumens rather than one. The second lumen allows for a continuous medication infusion to the coronary artery during percutaneous coronary intervention (PCI), the part of the procedure when the narrowed coronary artery is dilated.

"The potential impact of this device is far-reaching," said Dr. Rafi Hofstein, Hadasit president/CEO. "The Double Lumen PCI Guiding Catheter has potential to change existing coronary artery PCI protocol for the better and to positively affect millions of patients worldwide."

He said the next step is to build a prototype for use in a proof-of-concept study in man and added that Hadasit is seeking partners to help finance the initiative.

Hadasit is the technology transfer company of Hadassah Medical Organization in Jerusalem, and promotes and commercializes HMO's continuously generated intellectual property and R&D capabilities.

CoveValve completes ReValving system cases

CoreValve (Irvine, California) reported that five clinical evaluation sites - two in New Zealand and three in Australia - have completed their first series of proctored cases using the company's proprietary ReValving system for percutaneous aortic valve replacement, featuring a porcine pericardium valve mounted in a self-expanding frame.

During a 12-day period, 24 patients at hospitals in Auckland, Brisbane, Melbourne, Sydney and Hamilton underwent successful percutaneous aortic valve replacement with the system. These hospitals are participating in a clinical evaluation registry as required for market clearance in Australia and New Zealand.

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