Edwards Sapien 3 TAVI Granted European Approval to Treat Low-risk Patients

TAVR cleared for low-risk patients in Europe with aortic stenosis using 

minimally invasive transcatheter valve

November 6, 2019 — Edwards Lifesciences announced it received European CE mark to expand use of the Edwards Sapien 3 transcatheter aortic valve replacement (TAVR) device for the treatment of patients diagnosed with aortic stenosis who are at low risk for open-heart surgery. The Edwards Sapien 3 valve is the first transcatheter aortic valve implantation (TAVI) system to have this indication in Europe.

"Now, all European patients diagnosed with aortic stenosis can be considered for TAVI with the Sapien 3 valve based on factors such as anatomical considerations or other individual needs rather than risk scores," said Prof. Helge Möllmann, director, Clinic for Internal Medicine (Cardiology) at St. Johannes Hospital, Dortmund, Germany. "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 Sapieen 3 valve."

This indication expansion in Europe follows on the publication earlier this year of data from the pivotal PARTNER 3 trial, an independently evaluated, randomized clinical trial comparing outcomes between TAVI and open-heart surgery in patients with a low surgical risk. TAVI with the Sapien 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and re-hospitalization at one year. The data were published in the New England Journal of Medicine. 

An additional study examining quality of life in the PARTNER 3 patients, which was published online in the Journal of the American College of Cardiology,[1] demonstrated significant early and sustained advantages for low-risk patients treated with the Sapien 3 valve. When the treatment strategies of TAVI and surgery were compared for low-risk patients, the TAVI patients improved more rapidly than surgery patients. This study showed, for the first time, patients treated with the Sapien 3 valve experienced a better quality of life even one year after the procedure.

In August 2019, the U.S. Food and Drug Administration (FDA) also approved the Sapien 3 and the Medtronic CoreValve Evolut TAVR systems for use in low-risk patients in the United States. This move is widely seen as opening the floor gates for TAVR procedural volume. Several experts in the field predict TAVR will take over 75 percent of aortic valve replacement procedural volume by 2025 in the U.S., and reduce open-heart surgical volumes to about 25 percent for patients who do not qualify for TAVR for various reasons.

The Sapien TAVR valves are the most widely studied transcatheter valves, with more than 30,000 patients treated in clinical trials and registries in over 65 countries around the world.  Since the first commercial approval of the Sapien transcatheter valve in Europe in 2007, the Sapien family of valves have treated hundreds of thousands of patients worldwide. The more advanced Sapien 3 TAVI system, first approved in Europe in January 2014 for the treatment of high-risk patients and then expanded to intermediate-risk patients, builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards Sapien valves. While prior experience demonstrates that it takes some time for clinical practice to evolve, this new low-risk indication for the SAPIEN 3 valve in Europe should facilitate changes in clinical practice guidelines and reimbursement, to improve future access for patients.

For more information: www.edwards.com

Related TAVR Content:

FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology

VIDEO: The Expansion of TAVR Following the FDA Clearing its Use in All Patients — Interview with Torsten Vahl, M.D. at TCT 2019

Study Finds Sustained Benefit for TAVR vs. SAVR at One Year - Results from the PARTNER Quality of Life Substudy

Edwards Recalls Sapien 3 Ultra Delivery System Due to Burst Balloons During Surgery

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VIDEO: TAVR for Degenerated Surgical Valves - Valve-in-Valve TAVR Procedures — Interview with Sammy Elmariah, M.D.

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Reference:

1. Suzanne J. Baron, Elizabeth A. Magnuson, Michael Lu, et al. Health Status after Transcatheter vs. Surgical Aortic Valve Replacement in Low-Risk Patients with Aortic Stenosis. Journal of the American College of Cardiology. September 2019. DOI: 10.1016/j.jacc.2019.09.007.