Will Late Loss Debate Stifle Device Start-Up Innovation?
The failure of Medtronic's Endeavor stent to hit its primary clinical trial goals has again spurred debate over surrogate endpoints, a poetntially big issue for small companies.
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A look back at the biggest devices stories of the decade, in capsule form.
Late stent thrombosis (LST) concerns associated with drug-eluting stents (DES) dominated sessions at the 2006 Transcatheter Cardiovascular Therapeutics (TCT) annual conference, with additional long-term data presented on this topic. The general feeling expressed was one of relief that the expanded dataset presented at TCT showed the LST problem was not as bad as some had feared when the issue was discussed at the World Congress of Cardiology (WCC).
Most medical device start-ups seeking to tap into the enormous drug-eluting stent market have focused on novel stent or stent platform design, on the theory that drug efficacy is a given. But X-Cell Medical is betting that they've come up with a better drug. And they're making their case by stressing the importance of safety.