Conor Medsystems, Biotronik DES Would Compete With Established Players
This article was originally published in The Gray Sheet
Executive Summary
Conor Medsystems expects technological characteristics - not price - will successfully position its CoStar drug-eluting stent against offerings from Johnson & Johnson and Boston Scientific
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Financings In Brief
Xtent: Menlo Park, Calif.-based firm will use proceeds of $25 mil. financing led by Morgenthaler Ventures to finish development and launch its Custom Nx coronary stent - which elutes Biosensors' Biolimus A9 drug - in the European market by Q4 2006 (1"The Gray Sheet" May 31, 2004, p. 17). Xtent will commence enrollment of a 100-person clinical trial this summer to support a CE mark. The DES system is meant to treat long, diffuse lesions and multiple lesions more rapidly and accurately than currently available devices by using a delivery system that deploys a divisible stent to different parts of the vessel, thereby minimizing catheter exchange, Xtent explains. Following EU marketing, the 48-person company will begin a 1,500-subject pivotal trial to support U.S. approval, expected in 2008. President & CEO Greg Casciaro joined Xtent last September. He previously served as CEO of Healos bone graft substitute manufacturer Orquest, which J&J/DePuy acquired in 2003 (2"The Gray Sheet" Feb. 3, 2003, In Brief)...
Financings In Brief
Xtent: Menlo Park, Calif.-based firm will use proceeds of $25 mil. financing led by Morgenthaler Ventures to finish development and launch its Custom Nx coronary stent - which elutes Biosensors' Biolimus A9 drug - in the European market by Q4 2006 (1"The Gray Sheet" May 31, 2004, p. 17). Xtent will commence enrollment of a 100-person clinical trial this summer to support a CE mark. The DES system is meant to treat long, diffuse lesions and multiple lesions more rapidly and accurately than currently available devices by using a delivery system that deploys a divisible stent to different parts of the vessel, thereby minimizing catheter exchange, Xtent explains. Following EU marketing, the 48-person company will begin a 1,500-subject pivotal trial to support U.S. approval, expected in 2008. President & CEO Greg Casciaro joined Xtent last September. He previously served as CEO of Healos bone graft substitute manufacturer Orquest, which J&J/DePuy acquired in 2003 (2"The Gray Sheet" Feb. 3, 2003, In Brief)...
Transcatheter Cardiovascular Therapeutics 2004 Meeting In Brief
Guidant SPIRITed by study results: MACE rate of 7.7% at six months for Guidant's drug-eluting stent is slightly higher - but statistically comparable - to rates associated with J&J/Cordis' Cypher and Boston Scientific's Taxus. At the Sept. 27-Oct. 1 TCT 2004 conference in Washington, D.C., Guidant releases six-month data from the 60-patient, randomized, single-blind SPIRIT-FIRST trial, showing angiographic in-stent late loss of 0.10 mm for the everolimus-elutingversion of the MultiLink Vision stent, versus 0.84 mm for bare-metal. Both of the major adverse cardiac events (2/23) linked to the DES occurred within the first 30 days, with no new events out to six months, Guidant notes. SPIRIT-FIRST tests a cobalt-chromium, durable-polymer stent system - a departure from Guidant's FUTURE trials assessing a stainless-steel stent platform with bioabsorbable-polymer. The study supports an IDE filing for a pivotal trial (1"The Gray Sheet" Sept. 20, 2004, p. 6)...