Boston Scientific recalls all Lotus Edge TAVR systems, halts research, manufacturing
Boston Scientific announced it has initiated a global voluntary recall of all unused inventory of its transcatheter aortic valve replacement system due to complexities linked to the product delivery system, according to a press release.
The voluntary recall is only for the delivery system (Lotus Edge, Boston Scientific), not the valve, and the company reports no safety issue for patients currently implanted with the valve.
According to the release, due to time and investment needed to develop and reintroduce an enhanced delivery system, Boston Scientific retired the TAVR system immediately, and all research and development and manufacturing of the product platform will cease.
“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,” Mike Mahoney, chairman and CEO of Boston Scientific, said in the release. “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.”