A Medical Device Daily

Coherex Medical (Salt Lake City) reported completing the first human cases with its Coherex FlatStent PFO Closure System.

Horst Sievert, MD, principal investigator for the COHEREX-EU study conducted procedures at Sankt Katharinen Hospital (Frankfurt, Germany), last week to close the common heart defect known as a patent foramen ovale (PFO).

A common heart defect that occurs in roughly 25% of the population, PFOs allow blood to bypass the lungs and shunt directly from the right side of the heart to the left, thus increasing the likelihood that blood clots in the heart flow directly to the brain and preventing the filtration of chemicals out of the blood that occurs in the lungs.

Joining Sievert in those cases were Brian Whisenant, MD, Coherex founder and chairman, and an interventional cardiologist with the Utah Heart Clinic at LDS Hospital (also Salt Lake City); Robert Somner, MD, director of the Adult Invasive Congenital Heart Services Center at New York-Presbyterian Hospital/Columbia University Medical Center and associate professor of clinical medicine and pediatrics at Columbia University (both New York); and Jonathon Tobis, MD, professor of medicine and director of interventional cardiology at the David Geffen School of Medicine at UCLA (Los Angeles).

“The Coherex FlatStent PFO Closure System worked flawlessly during each of our procedures,” Sievert said. “The device was extremely easy to use and there have been no complications from its use in any of the cases. The Coherex FlatStent marks the beginning of a new era of medical device technology and significantly raises the bar by providing a simple and safe alternative in PFO closure for physicians and their patients.”

“These results are the product of many years of research and hard work by Coherex’ employees,” said Richard Linder, company president and CEO. “Our assertion that the Coherex FlatStent is a new breed of stent to treat heart defects has now been successfully validated in patients and confirms the confidence our investors have had in our vision. We look forward to additional clinical research in Europe as part of the COHEREX-EU Study.”

Coherex said it expects to include data from the Frankfurt cases in its application for CE-mark clearance.

“The FlatStent technology was straightforward and extremely easy to use,” Sommer said. “The device is unique in its construction and is designed to sit almost entirely within the PFO tunnel, with minimal mass and minimal left atrial exposure.”

Tobis called the FlatStent technology “an exciting new advance in PFO closure, since nearly the entire device is embedded within the inter-atrial tunnel. My expectation is that the scar tissue will remain within the tunnel and effectively close the right to left shunt. This should have a significant effect in preventing paradoxical emboli in stroke patients, and hopefully we can demonstrate in future clinical trials that migraine headaches will also be reduced with the Coherex FlatStent.”

Coherex noted that there are at least two medical conditions that may benefit from PFO closure: stroke and migraine. According to the American Heart Association (Dallas), some 500,000 strokes each year worldwide may be attributable to the presence of a PFO, which represents a potential annual market size of close to $2 billion. And multiple retrospective studies have demonstrated a marked reduction in migraine symptoms following PFO closure. The worldwide market potential for PFO closure to treat migraine patients has been estimated to be more than $15 billion a year.

Perlegen in license for breast cancer markers

Perlegen Sciences (Mountain View, California) said it has obtained an exclusive license from Cambridge Enterprise, the commercialization office of the University of Cambridge in the UK, to the breast cancer markers identified through collaborative research between the parties that was previously reported in February 2005.

The study identified breast cancer susceptibility markers that are present in about 20% of UK breast cancer cases. By comparison, previously identified genetic variants such as in the genes BRCA1 and BRCA2 are much rarer, occurring in less than 5% of breast cancer cases.

Although common, these risk alleles — forms of DNA sequenced at a specific location — confer somewhat less overall risk than other described markers, doubling breast cancer risk in cases which have two copies of the variants vs. those with none.

Perlegen will commercialize a diagnostic test, either directly or through a sub-license agreement with a third party. Cambridge University and Cancer Research Technology (CRT), whose parent organization is Cancer Research UK (London), will share in any financial returns. Cambridge University also may provide non-commercial licenses to academic researchers.

The results of the collaboration were published in June in the journal Nature in a study reported by Douglas Easton et al. That study, termed “the most comprehensive study of breast cancer genetics ever conducted,” was based on reading the DNA of more than 50,000 women.

The samples used in the study were coordinated by the researchers at Cambridge University through a variety of clinical collaborators around the globe. Perlegen genotyped the samples to determine the genetic variation in each sample. Funding was provided by Cancer Research UK.

In announcing Perlagen’s receipt of a license for commercialization, the parties said that more than 1 million women are diagnosed annually with breast cancer. “The near-term diagnostic, and possibly longer-term therapeutic, application of these findings could benefit breast cancer patients through improvements in prevention, earlier detection and ultimately treatment of breast cancer,” the statement said.

“The next step for this research is to translate our greater understanding of the genetic basis of the disease into new technologies that will directly benefit breast cancer patients,” said Keith Blundy, CEO of CRT.

“We look forward to further developments in this field, which ... will hold the promise of improving the healthcare for the many women with these novel susceptibility genetic markers,” said Bryan Walser, CEO of Perlegen Sciences.

Dr. Iain Thomas, head of life sciences at Cambridge Enterprise Ltd., added: “One in nine women in the UK will be diagnosed with breast cancer. We hope the results of this study will make an important difference for many of these women.”