November 17, 2020
Boston Scientific Recalls and Discontinues Lotus Edge Aortic Valve System
November 17, 2020—Boston Scientific Corporation announced it has initiated a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system because of complexities associated with the product delivery system.
The company advised that the voluntary recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance postimplant. There is no safety issue for patients who currently have an implanted Lotus Edge valve.
According to Boston Scientific, because of the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire Lotus product platform immediately. All related commercial, clinical, research and development, and manufacturing activities will also cease.
Mike Mahoney, Chairman and Chief Executive Officer of Boston Scientific, stated in the company’s press release, “While we have been pleased with the benefits the Lotus Edge valve has provided to patients, we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve. The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform. We will instead focus our resources and efforts on our Acurate Neo2 aortic valve system, Sentinel cerebral embolic protection system, and other high-growth areas across our portfolio.”
On September 28, Boston Scientific launched the CE Mark-approved Acurate Neo2 transcatheter aortic valve replacement (TAVR) system in Europe. In the United States, the Acurate Neo2 valve system is an investigational device being assessed in the ACURATE IDE investigational device exemption clinical trial. The Sentinel system, which is designed to protect patients against the risk of stroke during TAVR procedures, received CE Mark approval in 2014 and FDA clearance in 2017.