Boston Scientific Recalls LOTUS Edge Aortic Valve System

Boston Scientific Corp. has initiated a global recall of all unused inventory of the LOTUS Edge Aortic Valve System due to complexities associated with the product delivery system.

The company has also decided to retire the entire LOTUS product platform immediately, and to stop all related commercial, clinical, research & development and manufacturing activities. The decision to stop the production was due to the additional time and investment required to develop and reintroduce an enhanced delivery system.

According to the company, the recall is solely related to the delivery system. There is no safety issue for patients who currently have an implanted LOTUS Edge valve, which continues to achieve positive and clinically effective performance post-implant.

The company estimates the recall and the discontinuation of the production would result in total pre-tax GAAP charges of approximately $225 million to $300 million. Around $100 million to $150 million of these charges will impact the company’s adjusted results. The vast majority of these charges will be recorded during the fourth quarter of 2020.

The decision is expected to be accretive to GAAP and adjusted earnings per share in 2021 by approximately one to two cents and neutral thereafter.

Mike Mahoney, chairman and chief executive officer, Boston Scientific, said, “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 said it will now focus on ACURATE neo2 Aortic Valve System, Sentinel Cerebral Embolic Protection System and other high growth areas across its portfolio.

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