|
Utah company's new stent may help repair heart defects A device designed to close a common heart defect was implanted for the first time in humans Tuesday in several heart patients in Frankfurt, Germany. The surgeries mark the launch of a European clinical study of the device, called the Coherex FlatStent PFO Closure System, the brainchild of Salt Lake-based Coherex Medical Inc. If all goes well, the device then will begin the long FDA approval process in the United States as well, according to CEO and president Richard Linder. But first, the company plans to complete a global randomized trial to see its impact on closing the heart defect, called Patent Foramen Ovale, or PFO. Like fingerprints and snowflakes, each PFO heart defect is unique. And they are so common it is estimated that one-fourth of all mammals — people, pandas and pigs — have one. PFOs have been linked to strokes and to migraine headaches. The foramen ovale is a tunnel-like opening between a fetus' upper heart chambers that lets blood bypass the lungs, a good thing in the womb but not after birth, when it's supposed to close. Those that don't are called "patent." Because a PFO lets blood skip the lungs and shunt directly from the right side of the heart to the left, clots formed in the body can get into the arteries that feed the brain and result in a cryptogenic stroke. A half-million cryptogenic strokes worldwide every year are directly attributed to PFOs. Even more often, researchers believe, PFOs are directly responsible for some migraine headaches, although the "how" and "how many" are unknown. Various companies have tried different things, from one that focuses on sutures to a variety of implantable devices, but it hasn't been easy, Linder said. The FlatStent implanted this week is Coherex's third-generation device, although it's the first one the company has tried in humans. It was determined to devise something interventional cardiologists could use and tried a couple of different approaches, including radio-frequency-based technology. When that didn't work, the company opted to try something new. Calling it a stent may seem confusing, admits Dr. Brian Whisenant, an interventional cardiologist at LDS Hospital who founded Coherex and chairs its board. People are used to thinking of stents as the little circular rings that are inserted in veins and arteries to keep them open, not a flat device used to close a heart defect. But it is similar in function to those self-expanding vascular stents so widely deployed by interventional cardiologists. "It's just a very different kind of stent," says Linder. And unlike a more typical stent, where the coating that forms in reaction to having foreign material in the body is bad (a process called restenosis that renarrows the blood vessels), the FlatStent for PFOs relies on that coating to help seal the defect. Linder predicts it will soon be clear whether the German surgeries are effective. The patients will be followed for six months and trans-thoracic echocardiograms used to see that the PFO is entirely closed. The surgeries at Sankt Katarinen Hospital in Frankfurt were led by Dr. Horst Sievert, an internationally renowned interventional cardiologist and principal investigator for the European study. Others involved included Whisenant; Dr. Robert Sommer, director of the Adult Invasive Congenital Heart Services Center at New York-Presbyterian Hospital/Columbia University Medical Center; and Dr. Jonathan M. Tobis, professor of medicine and director of Interventional Cardiology at the David Geffen School of Medicine at the University of California Los Angeles. Information about the new stent is online at www.coherex.com. |
09/22/09
08/20/09 07/08/09 10/13/08
10/03/07 10/01/07
05/10/07
|
Notice: The Coherex FlatStent EF PFO Closure System has been CE Marked and is currently distributed outside the U.S.A. and Japan by Abbott Vascular. It is not available for investigational use or for commercial distribution at this time in the U.S.A.
