FDA Proposes Stent Guidelines

-Wall Street Journal

03/27/2008 - The Food and Drug Administration proposed tougher clinical-trial guidelines for drug-coated stents in response to concerns about blood clotting in the artery-opening devices long after implantation.

The move is the first concrete change since the FDA held a two-day meeting in December 2006 about whether such stents increase the risk of clots compared with bare-metal stents years after the procedure. Coated stents don't appear to increase deaths or blood clots overall; whether they increase late clots years after implantation is still debated.

Instead of assessing patients' progress and health in trials nine months after a stent is implanted, the agency will now require companies to submit trial data on patients' health one and two years after the procedure, before stents can be approved. The new draft guidelines appear to codify standards that the FDA used to assess trials for new stents from Medtronic Inc. and Abbott Laboratories.

The FDA's proposals are "relatively broad in nature and conform to the way the industry has already been thinking about product design," said Phil Nalbone, an analyst at RBC Capital Markets in San Francisco.

About a million people each year in the U.S. undergo procedures to treat heart-artery blockages. Stents prop open clogged arteries. Models coated with drugs to reduce reclogging, from Boston Scientific Corp., of Natick, Mass., and Johnson & Johnson, of New Brunswick, N.J., account for most of the U.S. market.

The guidelines aren't expected to affect coated stents already on the market, or cause further delays at Boston Scientific, which is still under a new-product probation from the FDA that has held up introduction of its next-generation heart stent in the U.S., said Mr. Nalbone.

The guidelines could affect up-and-comers such as medical-device company Xtent Inc., a Menlo Park, Calif., development-stage firm that is working to commercialize its stent. Gregory Casciaro, Xtent's chief executive, said the company had been planning for the new standards. "We've accounted for everything that we have seen" in the proposed guidelines, he said. Xtent's shares fell 5.2%, or 27 cents, to $4.90 in 4 p.m. composite trading on the Nasdaq Stock Market.

The FDA said that after a stent is approved, companies should continue monitoring, preferably for five years after implantation, for blood clots, heart attack or other complications. The guidelines are an effort to "minimize risks while preserving for patients the benefits of drug-eluting stents," the agency's device chief, Daniel Schultz, said in a statement. The FDA guidelines aren't legally binding, but most companies follow them to ensure approval of devices

If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possiblilty of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Call us toll free at 1-800-856-6405.