FDA Approves Edwards' Sapien 3 Ultra TAVR System

January 4, 2019—Edwards Lifesciences announced FDA approval for its Sapien 3 Ultra system for transcatheter aortic valve replacement (TAVR) in patients with severe symptomatic aortic stenosis who are determined to be at immediate or greater risk of open heart surgery.

In its announcement, Edwards explained the Sapien 3 Ultra system features valve enhancements and a new delivery system that address the needs of patients and clinicians. The system builds on the company’s years of experience in the development of tissue heart valves and on the proven benefits of Sapien valves, noted Edwards.

In November of 2018, Edwards announced European CE Mark approval for the Sapien 3 Ultra system, along with a controlled rollout and training to ensure high procedural success of the valve and delivery system in Europe, excluding Germany. Edwards looks forward to now introducing the system to United States patients as well.

John Webb, MD, commented in the company's announcement, “The Edwards SAPIEN 3 Ultra system provides meaningful technology improvements that help further optimize the [TAVR] procedure, adding simplicity and advancing patient care.” Dr. Webb is the Director of Interventional Cardiology and Cardiac Catheterization Laboratories at St. Paul’s Hospital in Vancouver, Canada, and Professor of Cardiology at the University of British Columbia in British Columbia, Canada.