Dive Brief:

• Boston Scientific has received a CE mark for its newest transcatheter aortic valve replacement (TAVR) technology, the company said Tuesday.
• The device, Acurate Prime, is an update to Boston Scientific’s older Neo2 valve system. Changes include the addition of a larger valve size that company executives have said will open up 25% of the market that Neo2 is unable to serve.
• Boston Scientific has yet to receive approval for Neo2 or Prime in the U.S. The company dropped plans to win authorization this year to await one-year results of its clinical trial.

Dive Insight:

Boston Scientific has made inroads into the European TAVR market despite competition from Edwards Lifesciences and Medtronic. CEO Michael Mahoney said at a TD Cowen event in March that the company has “over 20% share in most accounts that we’re launched in.” However, Mahoney also said the lack of a large Neo2 valve size meant Boston Scientific “probably missed 25% of the market in Europe.”

Acurate Prime is designed to unlock that 25% of the market. On an earnings call in July, Mahoney said the device is the “next-generation Acurate Neo2 that has all risk indications and the full-size matrix, which has been the challenge for us to date, with an optimized delivery in the valve frame.” 

The new system covers aortic annulus diameters between 20.5 and 29 mm, compared to a maximum of 27mm for Neo2. Edwards Sapien 3 TAVR valve is available in sizes up to 29mm. Medtronic sells a 34mm version of its Evolut R valve. Other changes include a redesigned deployment mechanism intended to enable accurate valve positioning.

Boston Scientific has retained the self-expanding design of its older Neo2 device for the Prime system. The company said it expects Prime to provide the benefits seen in Neo2 trials, “including low pacemaker and paravalvular leak rates, strong hemodynamic performance, as well as unrestricted coronary access for future procedures.”

Boston Scientific said it expects to launch Prime in Europe “in the coming weeks.” Mahoney said the company was targeting the fourth quarter of 2024 or first quarter of 2025 when he discussed the launch on the earnings call in July.

Boston Scientific is also working to bring the device to the U.S. market. The company was aiming to win Food and Drug Administration approval this year. However, Boston Scientific dropped that goal in January in response to an interim analysis of clinical data. The company has completed enrollment in the 1,500-patient cohort and, as of July, was aiming to present data at the American College of Cardiology meeting in March 2025.