Boston Scientific has achieved a significant milestone by receiving a CE mark for its latest transcatheter aortic valve replacement (TAVR) system, Acurate Prime. This new device represents an important improvement over its predecessor, the Neo2 valve system. Among the notable enhancements are the inclusion of a larger valve size, designed to cater to an additional 25% of the market which was previously inaccessible with the older Neo2 model. Primarily, these market limitations stemmed from the lack of availability in larger valve sizes necessary for certain patient groups.
Despite not having received U.S. approval for either Neo2 or Acurate Prime, Boston Scientific has made considerable progress in the European TAVR market. The company reports having secured over a 20% share in most accounts where their systems have been introduced in Europe. This penetration into the market, however, highlighted the gap caused by the absence of a larger valve option in the Neo2 system, prompting the development of Acurate Prime.
Acurate Prime is specifically designed to overcome these prior limitations by expanding the range of treatable aortic annulus diameters to between 20.5 and 29 mm, compared to Neo2’s upper limit of 27 mm. It directly competes with other major players like Edwards Lifesciences, whose Sapien 3 TAVR valve also reaches up to 29mm, and Medtronic, which offers a 34mm version through its Evolut R valve. This broadening of applicable sizes intends to capture the segment of the market Boston Scientific previously missed. Additionally, the Acurate Prime features a revamped deployment mechanism that seeks to facilitate highly accurate valve positioning during procedures, maintaining the self-expanding design characteristic of the earlier Neo2 system.
Boston Scientific has emphasized that the Prime system is slated to bring forward all the benefits observed during Neo2 trials, such as low rates of pacemaker necessity and paravalvular leaks, robust hemodynamic performance, and unrestricted coronary access for potential future treatments. This continuation of successful features is a cornerstone of the Prime system’s market appeal.
The commercial launch of Acurate Prime in Europe is anticipated to happen in the upcoming weeks, with the company targeting a broader introduction either in the fourth quarter of 2024 or the first quarter of 2025. Meanwhile, efforts are ongoing to navigate the regulatory landscape for U.S. market entry. Initially, Boston Scientific planned to obtain Food and Drug Administration (FDA) approval within the year. However, the company adjusted its timeline after an interim analysis of the clinical data led them to postpone this goal in January to a later date. Currently, Boston Scientific has finished enrolling patients in a large-scale, 1,500-patient clinical trial and is preparing to present these findings at the American College of Cardiology meeting in March 2025.
This development aligns with Boston Scientific’s strategic responses to market demands and technological advancements within the TAVR market, showcasing a concerted effort to not only enhance patient outcomes but also to solidify and expand their market share in this competitive field.
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