Boston Scientific’s new TAVR valve gains CE mark approval
Boston Scientific has received European CE mark approval for its newest transcatheter aortic valve replacement (TAVR) device, the self-expanding Acurate Prime Aortic Valve System.
According to Boston Scientific, the Acurate Prime system represents an evolution of its structural heart portfolio. The company’s last TAVR offering, the Acurate neo2 platform, gained CE mark approval in 2020, but was never approved by the U.S. Food and Drug Administration (FDA) for use in the United States. Acurate Prime is a next generation design with an updated frame and a new top-down deployment mechanism for improved valve positioning. In addition, it will be available in another size, providing treatment options for aortic annulus diameters from 20.5 to 29 mm. Other key features include the valve’s supra-annular leaflets and 360° dynamic sealing skirt.
“The introduction of the Acurate Prime technology offers physicians a TAVR option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment,” Janar Sathananthan, MD, Boston Scientific’s chief medical officer of interventional cardiology therapies, said in a statement. “Further, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients, allowing more clinicians to consider this technology for treatment in challenging or larger heart structures.”
“We are thrilled to offer physicians a new valve with meaningful improvements for the treatment of an increasing number of patients with aortic valve disease,” added Lance Bates, a senior vice president and president of interventional cardiology therapies.
Boston Scientific plans to officially launch the new-look TAVR device to its European customers in the weeks ahead. This device, like the Acurate neo2, has not gained FDA approval. It is only available in the United States for investigational use.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.