Sapien 3 Approved for Use in Intermediate-Risk Patients in Europe

Edwards Lifesciences has received CE Mark approval for expanding the use of the Sapien 3 transcatheter heart valve to patients with severe, symptomatic aortic stenosis at intermediate risk for open-heart surgery.

Data to support the European intermediate-risk indication come from the SAPIEN 3 study, previously reported by TCTMD. In a propensity-score analysis that compared patients treated with Sapien 3 and patients treated with surgical valve replacement in the PARTNER 2A randomized trial, TAVR using the balloon-expandable device was superior to heart-valve surgery.

The Sapien 3 balloon-expandable device is also approved in Europe for use in inoperable patients and those at high risk for death and complications associated with surgery.

Just last month, the US Food and Drug Administration gave a similar green light to Edwards by approving expanded indications for the Sapien XT and Sapien 3 valves in patients at intermediate risk for death or complications associated with surgical valve replacement. The Edwards announcement of the expanded CE Mark indication for intermediate-risk patients in Europe lists only Sapien 3, the newest device.

Earlier in August, Medtronic became the first over the intermediate-risk hurdle, with the company gaining an expanded indication to use the CoreValve Evolut R system in intermediate-risk patients with aortic stenosis in Europe. CoreValve Evolut R is not yet approved for use in intermediate-risk patients in the United States.

The FDA has given their blessing for two trials testing Sapien 3 and CoreValve Evolut R in patients with aortic stenosis at low risk for open-heart surgery.

In PARTNER III, a trial using the Sapien 3 valve, investigators will enroll approximately 1,300 elderly patients identified by a heart team as being at low risk for mortality were they to undergo surgical valve replacement (STS score < 4). The Medtronic CoreValve study will include approximately 1,200 low-risk patients with severe aortic stenosis randomized to TAVR or surgery. In the Medtronic study, patients are considered low risk for surgery if they have a less than 3% risk of death from valve-replacement surgery.

Related Stories:

• Sapien 3 Superior to Surgery Among Intermediate-Risk Patients in Observational Trial
• FDA Approves Sapien XT and Sapien 3 for Intermediate-Risk Patients
• FDA Grants Go-Ahead for Low-Risk TAVR Study