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Boston Scientific states after initiating a voluntary recall for the LOTUS and LOTUS Edge Aortic Valve Systems earlier this year, Boston Scientific implemented manufacturing process and design specification changes to the LOTUS Edge delivery system with the intent of re-introducing the product in Europe by the first quarter of 2018 and filing the final Pre-Market Approval (PMA) module with the U.S. Food and Drug Administration by January 2018.
The company now expects to provide an update on the status of the LOTUS Edge Valve during its fourth quarter 2017 earnings conference call on February 1, 2018, as it continues to focus on manufacturing and regulatory milestones to support the long-term success of the Lotus platform.
Mike Mahoney, chairman and chief executive officer, Boston Scientific, “We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients with aortic stenosis.” He concluded, “While we are disappointed in this delay to our timelines, we are working to carefully analyze and implement necessary modifications to pass our rigorous internal quality standards.”
Boston Scientific will continue to work closely with the U.S. and European regulatory bodies to share pertinent updates about these delays and impact to submission timing.
Today’s announcement is not expected to have a material financial impact to Boston Scientific fourth quarter or full year 2017 guidance.
Conference Call and Webcast Information
Boston Scientific will be hosting a conference call for investors on Wednesday, November 29, at 8:30 a.m. EST to discuss the announcement. To participate in the conference call, please dial (800) 230-1096 or (612) 234-9959. The live webcast and archived replay of this call will be available at our Investor Relations website investors.bostonscientific.com in the Events section.