November 5, 2019
Edwards' Sapien 3 TAVR System Approved in Europe for Low-Risk Patients
November 6, 2019—Edwards Lifesciences announced that it has received CE Mark approval to expand use of the Sapien 3 transcatheter heart valve for the treatment of patients with aortic stenosis who are at low risk for open heart surgery.
According to the company, this indication expansion in Europe is supported by data from the pivotal PARTNER 3 randomized clinical trial comparing outcomes between transcatheter aortic valve replacement (TAVR) and open heart surgery in patients with a low surgical risk. In the trial, TAVR with the Sapien 3 system achieved superiority, with a 46% reduction in the event rate for the primary endpoint, which was a composite of all-cause mortality, all stroke, and rehospitalization at 1 year.
The data were presented in March 2019 by Martin B. Leon, MD, at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans, Louisiana, and published by Michael J. Mack, MD, et al in The New England Journal of Medicine (2019;380:1695–1705).
An additional study examining quality of life in PARTNER 3 patients demonstrated significant early and sustained advantages for low-risk patients treated with the Sapien 3 valve. Patients improved more rapidly and experienced a better quality of life at 1 year after the procedure compared with surgery patients.
In September, Suzanne J. Baron, MD, presented the results from the PARTNER 3 Quality-of-Life Substudy at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California. Dr. Baron et al published the findings online in Journal of the American College of Cardiology.
In the company’s announcement, Professor Helge Möllmann, MD, commented, “Now, all European patients diagnosed with aortic stenosis can be considered for TAVR with the Sapien 3 valve based on factors such as anatomical considerations or other individual needs rather than risk scores. This is particularly important for patients at low risk for surgery, whose only serious health issue may be aortic stenosis and who want to return to their lives more safely and quickly. Previously, their only treatment option was open heart surgery, and this approval will expand access to the proven Sapien 3 valve.” Prof. Möllmann is Director of the Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital in Dortmund, Germany.