Boston Scientific has been granted a CE mark from the European Union (EU) for its ACURATE Prime Aortic Valve System, a transcatheter aortic valve replacement (TAVR) aimed at patients living with severe aortic stenosis.
Indicated to restore function and normal blood flow through a narrowed aortic valve, the new system is equipped with a self-expanding, supra-annular design, which the company claims has an enhanced frame that equalises forces across the valve for a stable fit against the native, diseased valve.
The valve system will now be available to patients undergoing treatment with an aortic annulus diameter between 20.5mm and 29mm. Intended as a follow-on to the company’s previous ACURATE neo2 platform, ACURATE Prime similarly carries over its selection of additional valve sizes, expanding the treatment range to patients with larger anatomies.
Janar Sathananthan, chief medical officer of Boston Scientific’s interventional cardiology therapies arm, said: “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.
“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."
Boston Scientific says that it plans to launch the ACURATE Prime valve system in Europe in the coming weeks. GlobalData’s Medical Device Database details how by the end of this year, the TAVR is set to be worth an estimated $7.2bn, with that figure predicted to rise to $11.8bn by the end of 2030.
Boston Scientific senior vice-president Lance Bates added: “Built on the ACURATE valve platform, which has been implanted in nearly 80,000 patients globally to date, the ACURATE Prime valve system is engineered to improve long-term cardiac function and provide access for future treatment needs, thereby supporting the lifetime management of these patients."
The announcement comes after the medtech giant acquired US-based carotid artery device specialist Silk Road Medical for around $1.26bn in a bid to expand its cardiac offerings. Last month, Boston’s TAVR competitor Edwards Lifesciences announced the complete acquisition of TAVR specialist Innovalve BioMedical.
