Boston Scientific said it is voluntarily recalling all unused inventory of the Lotus Edge transcatheter aortic valve replacement system effective immediately.
In making the announcement today, Boston Scientific chair and chief executive officer Mike Mahoney said the company has been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve — key features of the system.
“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,” Mahoney said.
Instead, the company will focus on the ACURATE neo2 aortic valve system, the Sentinel cerebral embolic protection device, and other high-growth areas, he noted.
The decision is expected to result in a $225 million to $300 million pre-tax charge, with $100 million to $150 million of these charges to impact the company’s adjusted results.
The Lotus device was approved in the United States in April 2019 for use in patients with severe aortic stenosis at high surgical risk based on the REPRISE 3 trial.
The Lotus Edge valve was approved in Europe in 2016, but final testing and rollout of the valve in the United States were delayed following a 2017 global recall of all Lotus valves due to reports of premature release of a pin connecting the valve to the delivery system.
Issues with the delivery system led to other Lotus valve recalls in both 2016 and 2014.
“Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to retire the entire LOTUS product platform immediately. All related commercial, clinical, research & development and manufacturing activities will also cease,” the statement said.
There is no safety issue for patients who currently have an implanted Lotus Edge valve, the company said.
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