The FDA cleared Edwards Lifesciences‘ SAPIEN transcatheter heart valve for transfemoral replacement of the aortic valve in patients not suitable for traditional open heart surgery.
Transcatheter Aortic-Valve Implantation (TAVI) from Edwards has been shown to reduce mortality in certain patient groups compared with open surgery, a factor that led to the approval of the valve system.
In performing the TAVR procedure, the valve is crimped onto the catheter-based transfemoral delivery system, which is inserted into the body through a small cut in the leg. Once delivered to the site of the patient’s diseased valve, the Edwards SAPIEN valve is expanded with a balloon and immediately functions in place of the patient’s native valve.
The Edwards SAPIEN valve is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.
The safety and effectiveness of the Edwards SAPIEN transcatheter valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. The name of the trial signifies the important partnership between cardiac surgeons and interventional cardiologists, who were brought together to collaborate in patient evaluation, treatment and follow-up. Additional analyses of data from The PARTNER Trial demonstrated that patients receiving the SAPIEN valve experienced substantially better quality of life as compared to the control group patients, and also that TAVR was cost effective.
As part of this approval, FDA has requested the implementation of two substantial post-approval studies. One study will follow patients already enrolled in The PARTNER Trial, and the second study will track new U.S. patients. The company anticipates the second study will be incorporated into a new national patient registry.
Product page: Edwards SAPIEN Transcatheter Heart Valve
Flashbacks: SAPIEN Transcatheter Cardiac Valve Trial Going Ahead; Edwards Touts Results of SAPIEN Valve Study; Edwards Sapien Transcatheter Aortic Valve Makes Human Debut; Edwards Trials Company’s Minimally-Invasive Pulmonic Valve; Transcatheter Aortic-Valve Implantation (TAVI) Reduces Mortality Rate Compared to Standard Therapy