Boston Scientific announced Tuesday, Nov. 17, that it was initiating a voluntary recall of its LOTUS Edge Aortic Valve System. The global recall is due to “complexities associated with the product delivery system,” the company said, and there are no safety issues for patients who already have a LOTUS Edge valve.
Instead of developing a new delivery system from scratch, Boston Scientific has chosen to retire its LOTUS platform altogether. The company will now focus that attention on the marketing and development of other solutions.
“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 a prepared statement. “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.”
The global TAVR system recall and subsequent platform requirement are expected to cost Boston Scientific approximately $225 million to $300 million overall.