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.

Because of its construction, it adapts to a PFO's individual shape in terms of length and width. It's intended for the hearts of adults 18-65. Besides pulling the opening closed, it has a sponge polymer that encourages tissue to grow into it and integrate it into the heart's structure.

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.

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E-mail: lois@desnews.com