Bear Stearns 2003 Healthcare Conference In Brief
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences R&D: LifeStent biliary stent will launch within weeks, heralding series of peripheral stent offerings over next six months, Edwards VP-Technology Stuart Foster says at Bear Stearns annual healthcare conference in New York Sept. 8. Edwards is assembling a dedicated sales team to support the line, developed through agreements with Orbus and Syntheon (1"The Gray Sheet" Nov. 18, 2002, p. 23). Foster also notes that Perimount Magna should obtain FDA clearance by year-end. To be priced at a premium to Perimount, the next-gen mitral valve will feature improved hemodynamics and durability. Regarding catheter-based valve repair, Edwards expects the first clinical implants of its "edge-to-edge" procedure to begin in 2004. In 2005, Edwards anticipates clinical trials of a catheter-based replacement system for aortic valves. Also in Edwards' valve repair pipeline is the Thermafix anti-calcification method, which could be approved by FDA later this year. Edwards is preparing a modular PMA submission for the Lifepath AAA endograft, based on Phase II pivotal study data, to be presented at the VEITHsymposium in New York Nov. 21-24...