People with heart disease, and the doctors who treat them, now have access to a new medical device to open blocked coronary arteries.  The FDA has just approved the Endeavor drug-eluting stent from Medtronic. Stents are tiny metal mesh tubes that enable a minimally-invasive alternative to open-heart bypass surgery.

Endeavor meets a significant unmet patient need by providing the effectiveness of a drug-eluting stent but with a safety profile more commonly associated with a bare-metal stent, the benchmark for stent safety.

Stents are used to prop open heart arteries that have been cleared of blockages resulting from heart disease. They are usually implanted as part of a minimally-invasive procedure called angioplasty, where the blockage is cleared using a miniature balloon.

Drug-eluting stents deliver medication to the artery wall to reduce the risk of the artery becoming blocked again, a process known as restenosis. The devices have revolutionized the treatment of coronary artery disease by reducing restenosis rates by more than 50 percent compared to bare-metal stents.  Worldwide, more than six million people have been treated with drug-eluting stents.

But use of the drug-coated versions of the devices has declined over the past year because of concern about their long-term safety, including the small but serious risk of potentially dangerous blood clots forming around the stent a year or more after being implanted.  Known as very-late stent thrombosis, these clots can lead to heart attack and death.

Extensive clinical evidence involving thousands of patients has shown the Endeavor stent to be associated with exceptionally low rates of stent thrombosis and no confirmed cases of very-late stent thrombosis. 

The U.S. market launch of the Endeavor stent begins immediately. In anticipation of considerable demand, the company expects to ship 100,000 units of the new stent to U.S. hospitals in the next 30 days.

This video is provided by Medtronic, Inc