United States
Company name: Boston Scientific Corporation
Brand name: LOTUS Edge™ Aortic Valve System
Product recalled: LOTUS Edge™ Aortic Valve System
Reason of the recall: Delivery System Issues Potential inability to release the delivery system
FDA Recall date: January 11, 2021
Recall details: Boston Scientific Corporation (NYSE: BSX) 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. Conference Call and Webcast Information Boston Scientific will be hosting a conference call for investors on November 17, 2020 at 8:00 a.m. EST to discuss the announcement. To participate in the conference call, please dial (833) 685-0550 or (412) 317-5733. The live webcast and archived replay of this call will be available at our Investor Relations website investors.bostonscientific.com in the Events section.
Check the full recall details on
www.fda.gov
Source: FDA
