         |
|
|
|
|
|
|
|||||
Abbott
XIENCE™ Drug-Eluting Stent Submitted for FDA Approval |
|||||
One unique fact about the XIENCE drug-eluting stent application is that it is the first one to show superiority over an existing system, in this case the TAXUS® Paclitaxel-Eluting Coronary Stent System, manufactured by Boston Scientific. Both SPIRIT II and III clinical trials showed better results for the XIENCE in keeping arteries from reclosing. Another unique fact is that this is the first submission to request simultaneous FDA approval for a private label version of the XIENCE stent, dubbed the PROMUS™ Everolimus Eluting Coronary Stent System, which will be distributed by Boston Scientific. This corollary marketing situation is a result of the agreement made between Abbott and Boston Scientific during Boston's January 2006 acquisition of Guidant, the company that invented the XIENCE stent. Abbott loaned to or purchased stock from Boston Scientific to the tune of $8 billion to finance the merger and in return received all of Guidant's vascular businesses, with the understanding that they would share the new XIENCE drug-eluting stent. Abbott has been selling the XIENCE stent in Europe and Asia Pacific since last October, where it has a market share in the low teens. Abbott expects this share to grow to the low 20% range by year-end. Boston Scientific also markets the PROMUS outside of the United States. With submission of this application, Abbott is hoping to be able to launch XIENCE V in the United States in the first quarter of 2008. Most observers believe that XIENCE will be the fourth drug-eluting stent available in the U.S. Currently only the Boston Scientific TAXUS and the Johnson & Johnson / Cordis CYPHER are FDA-approved. Medtronic's ENDEAVOR stent is a bit farther along in the FDA approval process and Medtronic hopes to market its ENDEAVOR by the end of 2007. Because both Medtronic and Abbott's stents are second-generation devices, it is hoped that they will overcome some of the recently publicized problems associated with the older stents. In fact Medtronic recently presented 3 and 4 year data on its ENDEAVOR stent, which showed zero percent stent thrombosis in a cohort of 1300 patients -- data which has impressed many interventional cardiologists. In a recent, albeit unscientific, poll of 214 interventionalists on the physician-only web site, CRTOnline.org, 43% voted Medtronic's ENDEAVOR as the safest drug-eluting stent, with the TAXUS, CYPHER and XIENCE each getting only about 15%. Abbott's SPIRIT FIRST clinical trial (actually started by Guidant in 2003) also showed no late stent thrombosis, but that trial was only of 60 patients. |
|||||
Angioplasty.Org Home • PatientCenter send comments & suggestions
to "info at angioplasty dot org" |
|||||