Abbott Xience V stent trials
This article was originally published in The Gray Sheet
Company commences enrollment for its 1,125-patient, SPIRIT IV clinical trial to evaluate the everolimus-eluting coronary stent system against Boston Scientific's Taxus Express paclitaxel-eluting stent Aug. 14. The single-blinded, 40-site U.S. study will enroll more complex patients than evaluated in previous studies and include treatment of "up to three de novo...native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation," Abbott says. Patients will be randomized at a 2:1 ratio for treatment with either Xience V or Taxus. The primary endpoint will be "ischemia-driven target vessel failure at 270 days." Xience V, based on the Multi-Link Vision stent platform, will debut in Europe this year (1"The Gray Sheet" July 24, 2006, p. 9)...
You may also be interested in...
Abbott kicked off the premarket approval submission process July 19 for the Xience everolimus-eluting coronary stent, taking a step closer to capitalizing on its recent acquisition of Guidant's vascular business
Amunix’s XTEN technology for half-life extension and precise drug delivery has been used by multiple partners over the past 15 years, but now the firm is building its own cancer therapy pipeline.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.