Edwards Reports Strong LifeStent Leg Artery Data, But PMA Will Wait Till ’08
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences reported positive clinical results for its LifeStent femoral/popliteal stent, but FDA is asking for more bench test data for the product's PMA for the femoral indication
You may also be interested in...
Edwards Sells LifeStent Peripheral Business To Bard For $140 Million
Edwards Lifesciences is giving up on the peripheral vascular market to focus its resources on its heart valve and critical care businesses
Edwards Sells LifeStent Peripheral Business To Bard For $140 Million
Edwards Lifesciences is giving up on the peripheral vascular market to focus its resources on its heart valve and critical care businesses
FDA Rounds Up Biliary Stent Makers On Off-label Promotion
FDA gathered biliary stent manufacturers to discuss how to prevent off-label marketing for peripheral vascular disease while it clarifies the regulatory pathway for vascular stents