Lotus Edge TAVR Device Recalled and Discontinued Worldwide

The Lotus Edge transcatheter aortic valve system is no longer. Boston Scientific, its manufacturer, announced a voluntary global recall yesterday of all unused inventory and the immediate discontinuation of the program.

The US Food and Drug Administration approved the Lotus Edge in 2019 for patients with symptomatic severe aortic stenosis at high risk for surgery; European regulators granted it CE Mark approval in 2016. But Boston Scientific said the valve design had challenges, specifically its delivery system, such that axing it was the only viable option.

"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, Boston Scientific chairman and chief executive officer, said in a press 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 Lotus device has been recalled a couple of times over the last few years. In 2016, Boston Scientific recalled several lots because of breaks in the release mechanisms of the delivery system. In 2017, the company again recalled the valve following problems with the device’s locking mechanism.

This latest and final recall is also related to valve delivery. However, given the time and money needed to develop and introduce a better delivery system, the company has decided to bail on Lotus, immediately stopping all commercial, clinical, and manufacturing activities. In its statement, Boston Scientific said there are no safety issues for patients who currently have an implanted Lotus Edge device.

The company will continue with clinical trials testing its other TAVR device, the Acurate neo valve. Recent results from SCOPE and SCOPE 2, which tested the first-generation Acurate neo against Sapien 3 (Edwards Lifesciences) and CoreValve Evolut (Medtronic), respectively, were underwhelming, however. The Acurate neo2, a second-generation transcatheter valve updated to reduce paravalvular leak, is currently being launched at select European centers.