The approval gives US cardiologists access to a new medical device for safely and effectively treating patients with narrowed coronary arteries. Clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile. The Endeavor stent is said to be the first new drug-eluting stent approved by the FDA since 2004. The US market launch of the Endeavor stent will begin immediately.
Scott Ward, president of the CardioVascular business at Medtronic, said: “We expect to ship 100,000 units to US hospitals in the next 30 days to assure full availability of this next-generation technology.”