Medtronic Gets Approval for Drug-Coated Stent
Medtronic on Friday received federal approval to sell its drug-coated stent, the first to hit the U.S. market since safety concerns sank their popularity two years ago.
The Food and Drug Administration said it cleared the company's Endeavor stent for use in patients with clogged arteries. Medtronic said it expects to ship 100,000 units to hospitals in February.
Endeavor is one of a new generation of stents the industry hopes can rejuvenate U.S. demand for the drug-oozing devices, sales of which plummeted to $2 billion last year, down from a peak of $3.1 billion in 2005.
Stents are tiny, mesh-wire tubes that prop open arteries after they have been surgically cleared of fatty plaque. They became one of the most lucrative medical devices in modern history after companies began adding drug coatings to stents in 2003 to prevent blood clotting.
An estimated 6 million people worldwide have had one implanted.