Medtronic stent clears major FDA hurdle

.WASHINGTON (AP) – Medtronic’s drug-coated stent Endeavor cleared a major regulatory hurdle Wednesday, as government advisers recommended approval for the artery-opening device.

A panel of outside experts unanimously recommended the Food and Drug Administration approve the device with certain follow-up requirements for Medtronic, according to agency spokeswoman Karen Riley. Panelists said the company should be required to track the health of 5,000 patients with the device for at least five years.

While the FDA is not required to follow the panel’s advice, most analysts expect the agency to give Medtronic approval later this year to compete in the roughly $2 billion U.S. market for drug-delivering stents. Currently Boston Scientific Inc. and Johnson and Johnson are the only companies who currently market the products.

Physicians use the mesh-metal tubes to prop open clogged arteries. The drug coatings are meant to stop blood vessels from reclosing, though studies in the last year have suggested they may also lead to deadly blood clots after nine months.

As a result, use of drug-coated stents has fallen to about 65 percent of the market from more than 85 percent at this time last year. Bare metal stents make up the remainder.

Minneapolis-based Medtronic has tried to position Endeavor as a safer alternative to products now on the market, reporting there have been almost no instances of late-forming blood clots in patients.