Medtronic receives FDA recommendation for Endeavor stent

The US Food and Drug Administration (FDA) advisory committee has recommended that Medtronic’s Endeavor drug-eluting stent is given conditional approval as a treatment for coronary artery disease.

The decision will mark the first new drug-eluting stent to be introduced to the US since 2004 if the FDA follows the recommendations of its advisory committee.

Scott Ward, president of Medtronic’s cardio-vascular business, expressed his delight over the announcement and welcomed the careful consideration that was given to the data relating to the Endeavor stent.

“We will continue to work with the FDA to bring the Endeavor stent to the US market as soon as possible so that patients and physicians in the US can benefit from this next-generation technology,” he said.

The stent is currently available in over 100 countries outside the US but still remains an investigational device in America.

However the data presented to the FDA advisory committee showed that following clinical studies the Endeavor reduced restenosis in patients by more than 60 percent over its bare metal stent comparator ? Medtronic’s bare metal stent.

The data, taken from a clinical trial involving 2,100 patients, also demonstrated a reduction in the need for repeat procedures while maintaining an excellent long-term safety profile.

In October 2006, Medtronic announced the initiation of the Protect study involving 8,000 patients, comparing the Endeavor stent to the Cypher sirolimuseluting stent from Johnson & Johnson.