Carotid stent offerings grow
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/Cordis receives PMA approval for its Precise carotid stent with the AngioGuard embolic protection system, joining Abbott in the U.S. market. Cordis will launch Precise nationwide in about two weeks, the firm said Sept. 26. It will market the product using data from SAPPHIRE, the only randomized controlled trial comparing carotid stenting to endarterectomy. A 2004 FDA corporate warning letter delayed the application for years, but a recent inspection at a Cordis facility in Florida with no adverse observations allowed it to proceed, according to Cordis (1"The Gray Sheet" Sept. 11, 2006, p. 6). Meanwhile, Medtronic filed the first of three PMA modules in early September for its Exponent carotid stent with the GuardWire system with an eye on late 2007 approval. Boston Scientific hopes to get approval for the Carotid WallStent Monorail carotid stent and FilterWire in early 2007...
You may also be interested in...
J&J/Cordis expands Precise stent offerings
Rapid exchange versions of Cordis' Precise nitinol carotid stent and Angioguard emboli capture guidewire system debut following FDA approval late last year. Compared with the previously available, over-the-wire versions that debuted last autumn, the Precise RX and Angioguard RX facilitate single-operator use and "more efficient manipulation of the catheter and guidewire," the Johnson & Johnson subsidiary explains. The devices are indicated for carotid artery disease in patients at high risk for adverse events from surgical removal of carotid artery plaque (1"The Gray Sheet" Oct. 2, 2006, In Brief). Cordis' 10,000-patient Sapphire global registry will assess the 30-day major adverse event rate following use of Precise RX and Angioguard RX...
Carotid Stent Firms See Another Step Into Market With Expanded Coverage
Carotid artery stent manufacturers hope to maintain momentum in an evolving market in which they see significant potential for growth
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.