Lisa Salberg
03-11-2003, 03:20 PM
This may be interesting for those in need.
FDA ADVISORS RECOMMEND APPROVAL FOR CATHETER
The FDA should approve CryoCath Technologies' Freezor Cryoablation System to treat atrioventricular node reentry tachycardia, the agency's Circulatory System Devices Panel recommended last week. The Freezor is a flexible, single-use, minimally invasive cryoablation catheter designed to create focal lesions to treat high-risk arrhythmias near the atrioventricular node.
The panel's recommendation came with conditions, none of which CryoCath believes will delay the product's launch. The devicemaker said it expects a final FDA decision in June, and plans to launch the product later this year.
FDA ADVISORS RECOMMEND APPROVAL FOR CATHETER
The FDA should approve CryoCath Technologies' Freezor Cryoablation System to treat atrioventricular node reentry tachycardia, the agency's Circulatory System Devices Panel recommended last week. The Freezor is a flexible, single-use, minimally invasive cryoablation catheter designed to create focal lesions to treat high-risk arrhythmias near the atrioventricular node.
The panel's recommendation came with conditions, none of which CryoCath believes will delay the product's launch. The devicemaker said it expects a final FDA decision in June, and plans to launch the product later this year.