This morning Boston Scientific Corp. announced that it is permanently pulling all unused inventory of its Lotus platform—a transcatheter aortic valve repair system—from the market and issued a global recall. Retirement of the product comes as a result of “complexities” related to the product delivery system. Effective immediately, all commercial, clinical, R&D and manufacturing related to the Lotus product will also 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,” said Mike Mahoney, chairman and CEO of Boston Scientific in a company news 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.”
The company will shift its investment and resources to its Acurate neo2 aortic valve system, Sentinel cerebral embolic protection system and other “high growth” areas.
Patients who currently have an implanted Lotus valve are at no safety risk, according to Boston Scientific.