FDA's First Stent Approval Since 2004 (MDT, JNJ, BSX, ABT)

Medtronic, Inc. (NYSE: MDT) has just announced that it has received formal approval from the FDA to market its Endeavor Zotarolimus-Eluting Coronary Stent System for the treatment of coronary artery disease.

This had been under study for some time and had been used in more than 4,100 patients that had been followed-up for up to four years.  Medtronic noted that this affects an estimated 13 million people in the United States and is the country’s leading cause of death.  Medtronic will begin marketing of these stents immediately and said it EXPECTS TO SHIP 100,000 units to hospitals in the U.S. over just the next 30 days.

Boston Scientific (NYSE: BSX) and Johnson & Johnson (NYSE: JNJ) are competitors in this stent market, although stents have been under more scrutiny than in say 2003 to 2006.  Abbott (NYSE: ABT) is still waiting on a yeah or nay out of the FDA on its new stent.

Jon C. Ogg
February 1, 2008