Guidant Awaits SPIRIT Trial Data For Clear Vision Of Future Stent Business
This article was originally published in The Gray Sheet
Executive Summary
Feasibility data on the Multi-Link Vision cobalt-chromium, durable-polymer, everolimus-eluting stent will be key to predicting the stability of Guidant's DES technology platform in the post-Dollens era
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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)...