Boston Scientific continues to solidify its presence in the transcatheter heart valve replacement (THVR) market with the recent CE Mark approval of the ACURATE Prime™ Aortic Valve System. This advanced transcatheter aortic valve replacement (TAVR) device, also known as transcatheter aortic valve implantation (TAVI), is now available for commercial use in Europe. TAVR and TAVI refer to the same procedure, with the terms often used interchangeably by clinicians and in the industry. This new device promises to deliver improved outcomes for patients with aortic valve disease, further driving the adoption of minimally invasive heart valve procedures over traditional open-heart surgery.
The ACURATE Prime™ Aortic Valve System builds on the legacy of Boston Scientific’s previous TAVI/TAVR solutions. The newly designed self-expanding valve and delivery system offer greater precision, ease of use, and enhanced patient safety. With the device designed to facilitate stable positioning, it aims to reduce the risk of paravalvular leak (PVL) and other procedural complications. This innovation reflects the growing trend in cardiovascular care, where minimally invasive solutions are increasingly preferred by clinicians and patients alike.
The Growing Preference for TAVI/TAVR and THVR Devices
In recent years, the preference for TAVI/TAVR has grown exponentially among healthcare professionals. Traditionally, aortic valve replacement required open-heart surgery, which comes with higher risks, longer recovery times, and increased discomfort for patients. TAVI/TAVR, by contrast, is a minimally invasive procedure where a replacement valve is inserted via a catheter through a small incision. This method is associated with shorter hospital stays, quicker recovery, and better overall outcomes.
In the context of the broader THVR market, devices are typically classified by the specific heart valve they replace, including transcatheter aortic valve replacement (TAVR/TAVI), transcatheter mitral valve replacement (TMVR), and transcatheter pulmonary valve replacement (TPVR). Among these, TAVR/TAVI holds the largest market share, driven by its higher volume of procedures and increasing adoption rates.
The nomenclature for these devices includes both transcatheter heart valve replacement (THVR) and percutaneous heart valve replacement. In this context, “percutaneous” is often used interchangeably with “transcatheter,” though both refer to the same minimally invasive approach. For the sake of this discussion, the term THVR will be used to encompass all such devices.
Boston Scientific’s Market Position and Strategic Moves
Boston Scientific has established itself as a formidable competitor in the transcatheter heart valve replacement (THVR) market, specifically in the TAVI/TAVR segment. By 2023, the company was the third-leading competitor in the European TAVI/TAVR market. Boston Scientific’s strategic moves and acquisitions have allowed it to gain significant traction in an increasingly competitive market.
Boston Scientific entered the THVR market in April 2022 with the approval of its LOTUS Edge™ aortic valve system. The LOTUS Edge™ was a game-changer, designed to give physicians greater control during the valve replacement procedure. This device is the first fully repositionable and retrievable TAVR system, which means that physicians can assess the final position of the valve before releasing it, reducing the risk of complications and ensuring precise placement. The LOTUS Edge™ is approved for use in high-risk patients, making it a valuable option for those who may not be candidates for traditional surgery.
However, Boston Scientific’s presence in the THVR market didn’t start with the LOTUS Edge™. In 2017, the company acquired the ACURATE™ and ACURATE neo™ valve systems from the Swiss company Symetis. These devices have since played a crucial role in bolstering Boston Scientific’s TAVI/TAVR portfolio, particularly in Europe, where they have become well-regarded for their ease of use and reliability. The acquisition of Symetis allowed Boston Scientific to stay competitive in the TAVI/TAVR market, even after the initial recall of the earlier Lotus platform.
As the TAVI/TAVR market continues to grow, driven by the increasing demand for minimally invasive heart valve replacement solutions, Boston Scientific is well-positioned to maintain and expand its market share. The company’s strategy of acquiring innovative technologies and introducing new devices like the ACURATE Prime™ ensures that it remains a key player in the evolving landscape of cardiovascular care. With its robust portfolio and ongoing commitment to innovation, Boston Scientific is poised to continue being a major competitor in the TAVI/TAVR market, offering solutions that improve patient outcomes and cater to the preferences of modern cardiologists and surgeons.
The Future of the TAVI/TAVR Market
The future of the TAVI/TAVR market looks bright, with significant growth on the horizon. As the population ages, the demand for aortic valve replacement procedures will continue to rise. TAVI/TAVR is expected to play an even more prominent role in treating aortic stenosis, further displacing traditional surgical methods.
In Europe, all segments of the THVR market, including aortic, pulmonary, and mitral valve replacements, are set to grow over the forecast period. While the aortic segment remains the largest, innovations in TMVR and TPVR devices will also contribute to overall market expansion. Additionally, advancements in device design, such as those seen in the ACURATE Prime™, will continue to improve patient outcomes and drive further adoption of transcatheter approaches.
Despite the growing competition, Boston Scientific’s strategic investments and innovations position the company as a key player in the TAVI/TAVR market. As more devices like the ACURATE Prime™ gain approval and enter the market, we can expect increased competition, leading to further price competition but also enhanced technology that benefits patients worldwide.
Conclusion
Boston Scientific’s ACURATE Prime™ Aortic Valve System marks an important advancement in the TAVI/TAVR space. With its CE Mark approval, the company is poised to increase its market share in Europe, where TAVI/TAVR is rapidly becoming the preferred method of valve replacement. As the TAVI/TAVR market continues to expand, fueled by an aging population and a growing preference for minimally invasive procedures, Boston Scientific’s continued innovation and strategic positioning could drive significant growth in the coming years.
To learn more about the European Cardiac Surgery market, which includes full chapters on THVR (TAVI/TAVR), visit our European Cardiac Surgery Report page to receive a complimentary executive summary. If you’re interested in a broader perspective, explore our insights on the global market by visiting the Global Cardiac Surgery Market page.
