trial rather than the long-term data it has required for TAVR systems in the past.
Monday, June 22, 2015
FDA Approves Edwards' Sapien 3 TAVR System Earlier Than Expected
FDA Approves Edwards' Sapien 3 TAVR System Earlier Than Expected-graysheet:FDA has approved Edwards Lifesciences Corp.'s Sapien 3 third-generation balloon-expandable transcatheter aortic valve replacement (TAVR) for high risk and inoperable aortic stenosis patients based on short-term data from the PARTNER II trial rather than the long-term data it has required for TAVR systems in the past.
trial rather than the long-term data it has required for TAVR systems in the past.