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 [...]
Visudyne
February 13, 2004 by admin · Leave a Comment
On January 29, 2004, U.S. health authorities expanded patient reimbursement for QLT’s Visudyne therapy to treat Wet Age Related Macular Degeneration (AMD). The changes, which could take effect by October 2004, will make 40,000 to 60,000 new patients eligible for reimbursement, potentially doubling QLT’s current patient pool of about 60,000. Until now, Medicaid [...]