Boston Scientific Discontinues Aortic Valve System over Delivery System Issues
Boston Scientific has announced a worldwide recall of all unused LOTUS Edge aortic valve systems and said it will discontinue the product due to “complexities” related to its delivery system.
The transcatheter aortic valve replacement platform is being recalled and discontinued because the delivery system poses challenges to physicians when they need to fully reposition and recapture the valve, Boston Scientific said. The company will now focus on its ACURATE neo2 aortic valve system.
The FDA said that there are no safety issues for patients who have already been implanted with the valve system.