LOTUS Edge Aortic Valve System Voluntary Recall and Product Discontinuation

UltraSight Raises $13 million to Bring AI Guidance for Cardiac Ultrasound to Patient Point of Care

The Yozma Group Korea, Atain Specialty Insurance Company and the Weizmann Institute of Science participated in the round.

Jon Hopkins New Senior Vice President-Chief Development Officer of Legion Healthcare Partners

Over the past 23 years, Jon has held various positions at Varian Medical Systems including Director of Sales, Americas West & Latin America, Varian Proton Solutions and prior Director of Worldwide Sales, Varian Particle Therapy.

Sinan Batman Appointed CTO of TeraRecon

Batman brings rich industry experience to TeraRecon, including Chief Engineer at Carestream/Kodak Health Group, where he defined the vision for image-centric workflow information systems.

November 17, 2020

LOTUS Edge Aortic Valve System Voluntary Recall and Product Discontinuation: Boston Scientific Corporation has announced it has initiated a global, voluntary recall of all unused inventory of the LOTUS Edge Aortic Valve System due to complexities associated with the product delivery system.

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

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.

“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 chief executive officer, Boston Scientific. “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.”

This decision is expected to result in estimated total pre-tax GAAP charges of approximately $225 million to $300 million due to inventory, fixed asset, intangible asset and certain other exit charges and approximately $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.

 

spot_img

DON'T MISS

Subscribe to Medical Device News Magazine here.

Related Articles