GAITHERSBURG, Maryland (Reuters) - Medtronic Inc’s drug-coated Endeavor heart stent won unanimous support on Wednesday from U.S. advisers who said the device appeared safe and effective based on current data.
The committee urged the Food and Drug Administration to approve Endeavor, but also recommended a large follow-up study to address concerns that drug-coated stents may lead to blood clots months after implantation.
The FDA usually follows panel recommendations, and Medtronic said it expected a final ruling by year’s end.
Medtronic shares rose 1.1 percent to $57.50 in extended trading from their $56.85 close on the New York Stock Exchange.
Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep the vessels from reclogging.
The market for drug-coated stents, once near $6 billion a year, contracted sharply in the past year amid safety concerns. Some patients developed blood clots months after having the devices implanted, and many doctors reverted to older and cheaper bare-metal stents.
If approved, Endeavor would compete with Boston Scientific’s Taxus and Johnson & Johnson’s Cypher, the two drug-coated stents on the U.S. market now.
Panel members felt Medtronic’s data provided “reasonable assurance” of safety and effectiveness, said committee chairman Dr. Clyde Yancy, medical director at the Baylor Heart and Vascular Institute in Dallas.
The panelists debated how Endeavor compared with other drug-coated stents.
In one Medtronic study, Endeavor was as effective as Taxus when the rate of heart attacks, deaths and repeat procedures was calculated. But Endeavor failed to prove equivalent to Taxus on a secondary measure of blood vessel renarrowing.
“I’m still a little unsure where this product fits in the grand scheme” of drug-coated stents, said panel member Dr. Norman Kato, a cardiovascular surgeon from Encino, California.
Committee members said rates of blood clots were low with Endeavor but more patients needed to be followed longer to determine the extent of the risk.
The committee said Medtronic, as a condition of approval, should commit to a post-approval study with at least 5,000 patients followed for five years to look for blood clots that might appear a year or later after the device is implanted, as well as rates of deaths and heart attacks.
Medtronic said the recommendation was consistent with its own proposal and it welcomed the panel decision.
“We believe Endeavor provides the optimal combination of safety, efficacy and deliverability,” Scott Ward, president of Medtronic’s cardiovascular business, said in a statement.
The panel vote was “largely what the market was expecting,” JP Morgan analyst Michael Weinstein said.
He said doctors still don’t have the answer to the key question, which is “is Endeavor safer than Cypher and Taxus?”
But with no new drug-coated stent approved in 3-1/2 years, surgeons might be looking for an easier-to-use option, he said.
Weinstein has predicted Endeavor could grab 18 percent of U.S. market share for drug-coated stents in 2008.
At the panel meeting, FDA officials said they had asked for updated instructions on the Cypher and Taxus labels explaining that professional societies now recommend 12 months of anti-clotting drugs, such as aspirin and Plavix, for drug-coated stent patients who can tolerate the medicines.
The panel said Endeavor should come with the same language. All of the labels would note that shorter anti-clotting therapy was studied in clinical trials and note that optimal duration is unknown.
Plavix is sold in the United States by Bristol-Myers Squibb Co and Sanofi-Aventis.
Reporting by Lisa Richwine and Kim Dixon