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Medtronic so thoroughly addressed safety and efficacy issues in its pre-market approval application for the Endeavor Zotarolimus stent that it could raise the bar for other drug-coated stents under review by the Food and Drug Administration, said Dr Clyde Yancy, chairman of an FDA panel that voted in favor of Endeavor.
“The amount of data necessary for approval has increased,” Yancy said, following the panel’s unanimous endorsement of the Endeavor drug-eluting stent, DES. “What we saw today was an evolution of DES data.”
“The bar needs to be raised. We need to continue the evolution of this information,” said Yancy, who is medical director of Baylor Heart and Vascular Institute in Texas.
Medtronic spokesman Daniel Beach said the pre-market data for the Endeavor stent was the largest data set for a drug-eluting stent to be presented to an FDA panel. “We know we had good data,” Beach said.
Abbott Labs has a pending submission before the FDA for its Xience V Everolimus Eluting Coronary Stent System, while dozens of other drug-coated stents are in late-stage testing.
There is not yet sufficient data to compare the Endeavor stent to other drug-coated stents, Yancy said. Medtronic has compared its Endeavor Stent to Boston Scientific’s Taxus, but not to Johnson & Johnson’s Cypher. Data comparing Endeavor to Cypher will come from a post-market study that Medtronic initiated in anticipation of the panel’s decision, Beach said.
Based on two separate clinical studies, Endeavor would appear to have a lower rate of late-stent thrombosis than either Taxus or Cypher, Beach said. That assumption is based on two different clinical programs, so direct comparisons cannot be made, he said. Still, “it gives us a good guideline” of how Endeavor might compare to its potential rivals, Beach said.
The target completion date for the post-market study is December 2013, Beach said. Medtronic plans to enroll 8,800 patients in several countries and randomize them to either Endeavor or Cypher. Currently, the study is only recruiting in countries outside the US where the Endeavor stent has been approved, but will begin recruiting US patients immediately, if the FDA grants approval of Endeavor.
The FDA, which typically follows the advice of its panels, still must make a final decision on whether to approve Endeavor. If approved, the product could be launched prior to completion of the post-market study, Beach said.
While Yancy seemed comfortable with the safety and efficacy of Endeavor, he said more information is needed to fully assess the need for additional anti-clotting medication after a stent procedure. Draft labeling language presented by a Medtronic representative states that longer antiplatelet therapy may be beneficial, and notes that the American Heart Association suggests using this therapy for at least a year. This language is likely to be used for other marketed drug-eluting stents, Taxus and Cypher, the Medtronic official told reporters.
The FDA’s Circulatory System Devices Advisory Committee addressed these issues by calling for labeling changes and a post-marketing study of at least 5,000 patients to assess the rate at which arteries get re-clogged at the stent site in the years following the procedure - a condition known as late-stent thrombosis. The study also would assess cardiac death and heart attack.
Medtronic had anticipated that the panel would recommend approval of Endeavor, under certain conditions, Beach said. The Minnesota-based company already has initiated the post-market approval study called Protect. The study would need additional US study patients to fulfill the panel’s recommendation, and is expected to enroll quickly, Beach said.
Medtronic has a current market cap of USD 63.96bn.
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