Boston Scientific announced Tuesday that it has begun a voluntary global recall of its Lotus Edge Aortic Valve System, and retired the entire product line, because of problems associated with its delivery system.
The company emphasized in a news release that there is no safety issue for patients who have already received the bioprosthetic valve.
However, given the continued problems associated with the delivery system, Boston Scientific has opted to immediately retire the Lotus Edge product line. Moreover, the company will stop all related commercial, clinical, research and development, and manufacturing activities connected to the Lotus Edge.
In 2017, the company recalled both the Lotus and Lotus Edge, saying then that a pin in the tool that deploys the valve may get disconnected before the operator is ready to release the device.
“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 the 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. 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.”
Boston Scientific shares fell $2.54 to $35.50 per share in before-hours trading Tuesday.