DePuy Spine’s Charite Artificial Disc for Replacement of Spinal Discs
October 26, 2004 by admin · Leave a Comment
On October 26, 2004 DePuy Spine Inc. announced that the FDA had approved the Charite™ Artificial Disc. The Charite Artificial Disc, a device made of two metallic endplates and a movable high-density plastic center, is the first FDA approved artificial replacement for spinal discs. The standard surgical intervention for this indication is lumbar fusion surgery [...]
Cordis Carotid System for Carotid Artery Disease
On April 21, 2004 Cordis Corporation announced that the FDA’s Circulatory System Devices Panel had recommended approval of the Cordis Carotid System. Cordis’ pre-market approval application drew upon results of the SAPPHIRE Study, which included 334 high-risk surgical patients randomized to receive the stent with embolic protection vs. the traditional carotid endarterectomy. According to [...]
Taxus Express
March 5, 2004 by admin · Leave a Comment
On March 4, 2004, Boston Scientific announced that Taxus Express, its paclitaxel-eluting stent system for the treatment of coronary artery disease, had received FDA approval. The company indicated that it planned to launch Taxus Express in the United States immediately. Cordis Corporation’s Cypher™ stent (see Week and the newly approved Taxus stent are currently [...]
CYPHER Sirolimus-eluting Stent
February 20, 2004 by admin · Leave a Comment
On February 18, 2004, Cordis Corporation announced completion of patient enrollment in the first randomized head-to-head coronary stent trial comparing its new CYPHER sirolimus-eluting coronary stent with the Taxus Express (2) paclitaxel-eluting coronary stent. This trial is expressly designed to compare performance differences between the two drug-eluting stents, particularly in high-risk patient group subsets such [...]