CDRH Director Daniel Schultz said approval was granted after the center reviewed "a substantial amount of clinical evidence." Nothing less would have flown in today's climate. Indeed, Medtronic showed the agency data from a whopping seven trials. Their findings included positive data on the device's performance in regards to heart attack, cardiac death, and repeat procedures to re-open the coronary artery. Also importantly, blood-clot risk was similar to that for bare-metal stents. However, the agency advises patients to take blood-thinning medication for at least six months after the procedure. Also good news for Medtronic is that the DES market appears to have bottomed out. The Wall Street Journal reports that the market share for drug-eluting stents is no longer falling. It held steady for all four quarters of 2007.
