The FDA has issued approval for Edwards Lifesciences to introduce its SAPIEN XT trascatheter heart valve for aortic valve-in-valve procedures. The indication will help those already living with an aging prosthetic valve receive a new one without having to undergo an open heart surgery. The device has had FDA and CE approval since last year for transcatheter aortic valve replacements and has had European approval for aortic and mitral valve-in-valve implantation .
The new approval is based on a study involving 197 patients that showed a high one-year rate of survival (86.6%) and a low chance of stroke (3.7%) in patients who are already at high mortal risk. Moreover, at 30 days all 100 high risk patients were alive following the valve-in-valve procedure with the SAPIEN XT.
Flashbacks: Edwards SAPIEN XT Transcatheter Heart Valve FDA Approved…; Edwards SAPIEN XT Approved in Europe for Valve-in-Valve Aortic, Mitral Procedures…
Product page: Edwards SAPIEN XT…
Source: Edwards Lifesciences…