LOTUS Edge Aortic Valve System Voluntary Recall and Product Discontinuation

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.

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Led by researchers at NYU Grossman School of Medicine, the study results add to evidence that neighboring brain regions, the inferior frontal gyrus and the motor cortex, play an important role in such planning before words are said aloud. Both are part of the folded top layers of the brain, or cerebral cortex, which has long been known to control the muscle (motor) movements in the throat and mouth needed to produce speech. Less clear until now was how closely these regions determine the mix of sounds and words people want to say aloud, the authors report.
PolarisAR describes STELLAR Knee as a mixed-reality surgical navigation platform that guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The mixed-reality system acts as a spatial computer, creating continuous data exchange between the surgeon and the software to help enhance surgical decision-making while simplifying operating room workflow.
This February, the first enrolled patient underwent open surgical aortic arch reconstruction at the University of Pennsylvania, Presbyterian Medical Center, Philadelphia, PA.  During the surgery, the Duett Vascular Graft System was successfully deployed to connect the native left common carotid artery to the surgical graft.
"Our ultra low insertion loss Athermal AWG Multiplexers along with temperature-hardened low-drift AAWG specifically designed for the industrial temperature applications will be marketed aggressively through partnership companies in the East Asia and EU regions after its success in the North America," says Dr. Donald Yu, CMO of POINTek, who runs global marketing operations from Los Angeles, California.
AUX-001 is an innovative, once-daily, extended-release formulation of Nicorandil. For decades, immediate-release, twice daily Nicorandil has been a cornerstone treatment for chronic angina symptoms outside the US, distinguished by its dual mechanism of action that targets both the micro- and macrovascular coronary artery flow bed, and providing sustained angina symptom relief without the common issue of tachyphylaxis seen with other anti-anginal vasodilators like long-acting nitrates. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.

By using this website you agree to accept Medical Device News Magazine Privacy Policy