Boston Scientific announced a global, voluntary recall of the LOTUS Edge™ Aortic Valve. This voluntary recall is related solely to the complexities of the delivery system and is not related to the implanted valve. At this time, there are no known safety concerns for patients who have the LOTUS Edge valve implanted. The valve continues to show clinically effective performance post-implant.
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. This led us to the difficult decision to discontinue the LOTUS Edge platform.
Moving forward, we will be prioritizing and focusing our time and financial resources with a single valve platform –the ACURATE neo2 system which offers customers’ ease of use, low rates of PVL, best-in-class pacemaker rates, exceptional hemodynamics and better access to coronary arteries. We are encouraged by our ongoing launch in Europe and confident that this is the platform that will best serve patients, physicians and shareholders over the long term.
Read the full press release here.
Download a letter for patients here.