Dive Overview:
Boston Scientific announced Tuesday that it has received CE Mark for its latest transcatheter aortic valve replacement (TAVR) technology. The device, called the Acurate Prime, is an improved version of Boston Scientific's older Neo2 valve system. Changes include adding a larger valve size, which company executives say will open up 25 percent of the market that the Neo2 does not address. Boston Scientific has not yet approved the Neo2 or Prime in the U.S. The company has abandoned plans to seek approval this year as it waits for a year of clinical trial results.
Dive Insights:
Boston Scientific has received CE Mark for its latest TAVR system, the Acurate Prime.
Courtesy of Boston Scientific
Boston Scientific has made inroads in the European TAVR market despite competition from Edwards Lifesciences and Medtronic. CEO Michael Mahoney said at a TD Cohen event in March that the company has “more than 20% share in most of our customers that we've launched with.” But Mahoney also said that without the larger Neo2 valve, Boston Scientific “may have missed out on 25% of the European market.”
Acurate Prime is designed to unlock 25% of the market. During a July earnings call, Mahoney said the device is “the next generation of Acurate Neo2 with all the risk indications and the full-size matrix that has historically challenged us, and optimized delivery within the valve frame.”
The new system accommodates aortic annulus diameters from 20.5 to 29 mm, compared to the Neo2's maximum size of 27 mm. The Edwards Sapien 3 TAVR valve is available in sizes up to 29 mm. Medtronic sells a 34 mm version of the Evolut R valve. Other changes include a redesigned deployment mechanism to allow for precise positioning of the valve.
Boston Scientific is retaining the self-expanding design of its older Neo2 device in the Prime system. The company said it expects Prime to deliver the benefits seen in the Neo2 trials, including “low pacemaker and paravalvular leak rates, robust hemodynamic performance and unrestricted coronary access for future procedures.”
Boston Scientific said it plans to launch Prime in Europe “in the coming weeks.” Speaking about the launch on an earnings call in July, Mahoney said the company was targeting the fourth quarter of 2024 or the first quarter of 2025.
Boston Scientific is also working to bring the device to the U.S. market. The company had been hoping to get Food and Drug Administration approval this year. But Boston Scientific withdrew that goal in January following an interim analysis of clinical data. The company has completed enrollment in a 1,500-patient cohort and, as of July, was aiming to present data at the American College of Cardiology meeting in March 2025.
