The company said that there is no safety with those currently implanted in patients
Boston Scientific's Corporate Headquarters in Marlborough, MA. (Credit: Boston Scientific Corporation.)
Boston Scientific has commenced the voluntary recall of all the unused LOTUS Edge Aortic Valve Systems, due to the complexities related to the product delivery system.
The company noted that the voluntary recall is entirely related to the delivery system, while the valve delivers positive and clinically effective performance post-implant.
The patients who are already implanted with LOTUS Edge valve are not prone to any safety issues, said the company.
Boston Scientific chairman and chief executive officer Mike Mahoney said: “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.
“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.”
Boston Scientific to retire entire LOTUS product platform immediately
Boston Scientific said that it has decided to retire the entire LOTUS product platform right away, ceasing all related commercial, clinical, R&D and manufacturing activities.
The firm has made the decision after taking into account the additional time and investment needed to develop and reintroduce an enhanced delivery system.
The LOTUS Edge aortic valve system was approved by the US Food and Drug Administration (FDA) in April 2019. The system was developed to treat patients with severe aortic stenosis.
According to the company, aortic valve stenosis is the process of thickening and stiffening in the valve, which may result in an abnormal narrowing of the aortic valve opening and reduction in blood flow.
For Boston Scientific, the voluntary recall is expected to result in around $225m to $300m estimated total pre-tax GAAP charges, due to inventory, fixed asset, intangible asset and certain other exit charges.