Posts Tagged ‘FDA approval’

November 3rd, 2011

Sapien Transcatheter Aortic Heart Valve Gains FDA Approval

After much anticipation and drama, the FDA has approved the Sapien transcatheter heart valve (THV). The news was announced late Wednesday afternoon by the FDA and by Edwards Lifesciences, the manufacturer of the device. Details about the approval are scarce. The FDA said the Sapien THV has been “approved for patients who are not eligible for […]