Medtronic, Inc. has received approval from the US FDA for the Endeavor Zotarolimus-Eluting Coronary Stent System to be used for the treatment of coronary artery disease, which affects an estimated 13 million people in the US and is considered to be the country's leading cause of death.

Based on the most compelling and comprehensive body of scientific evidence submitted to the FDA for a drug-eluting stent, the approval gives US cardiologists access to a new medical device for safely and effectively treating patients with narrowed coronary arteries.

The Endeavor data encompasses the largest, most wide-ranging patient population submitted to the FDA in support of a drug-eluting stent, including more than 4,100 patients, followed up for as long as four years. This extensive 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 the first new drug-eluting stent approved by the FDA since 2004.

Endeavor is a next-generation drug-eluting stent because of its design, which combines an advanced stent platform with the potent drug zotarolimus and a biocompatible polymer, said Dr Martin B Leon, professor of medicine at Columbia University Medical Centre in New York, cardiologist at New York-Presbyterian Hospital/Columbia University Medical Centre, founder and chairman emeritus of the Cardiovascular Research Foundation, and principal investigator of the ENDEAVOR III and IV clinical trials.

The US market launch of the Endeavor stent begins immediately. "We have been strengthening our field and manufacturing capabilities in anticipation of considerable demand for the Endeavor stent in the US. We expect to ship 100,000 units to US hospitals in the next 30 days to assure full availability of this next-generation technology", said Scott Ward, president of the CardioVascular business at Medtronic.

The Endeavor clinical programme includes seven studies: three randomized controlled trials and four registries. Medtronic FDA submission included clinical data on more than 2,100 patients treated with the Endeavor stent, 1,287 of whom were studied to two years and 675 to three years.

The Endeavor stent offers clinical effectiveness that is consistent with the current market-leading drug-eluting stent in the United States. Endeavor IV, the randomized controlled trial comparing the Endeavor stent with Boston Scientific†s Taxus stent, met its primary endpoint, with a target vessel failure (TVF) rate in Endeavor patients of 6.6 per cent at nine months. The TVF rate for Taxus patients at nine months was 7.2 per cent. Importantly, Endeavor had similar efficacy compared to Taxus for all lesion subsets analyzed, and there were no statistically significant differences in target lesion revascularization (TLR), the clinical measure for repeat procedures.

Compared to a bare-metal stent in the Endeavor II clinical trial, the stent has been shown to reduce the need for repeat procedures by more than 61 percent in nine months. This treatment effect is sustained, with only 7.3 per cent of Endeavor patients in this randomized controlled trial requiring a repeat procedure out to three years of follow-up.

Ultimately, the Endeavor clinical programme will enrol more than 22,500 patients followed to five years; approximately 16,630 of these patients will receive an Endeavor stent. As a condition of US FDA approval, Medtronic will continue its extensive post-market clinical program, which will now add sites in the US to ensure that at least 5,000 patients are followed to a minimum of five years. In addition, it will collaborate with the FDA to conduct or participate in a study intended to identify the optimal duration of dual antiplatelet therapy following percutaneous intervention with the Endeavor drug-eluting stent.