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Boston Scientific's ACURATE Prime Aortic Valve System Wins CE Mark
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Boston Scientific, Inc. (BSX - Free Report) has obtained a CE Mark for the ACURATE Prime Aortic Valve System — the newest transcatheter aortic valve replacement (TAVR) technology in its structural heart portfolio. The system builds upon the clinical performance of the ACURATE neo2 platform, featuring several enhancements, including an additional valve size, which expands the treatment range to patients with a larger anatomy.
The latest development is expected to boost the company’s Interventional Cardiology Therapies, a component of its Cardiology unit.
Significance of Boston Scientific’s Newest TAVR Option
The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes forces across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes.
The ACURATE Prime technology offers physicians a TAVR approach to streamline procedural preparation, improve performance in complex cases and simplify delivery for quick and controlled deployment. Clinical experience with the valve has demonstrated its ability for precise positioning across a broader population of patients, enabling more clinicians to consider this technology for treatment in challenging or larger heart structures.
Image Source: Zacks Investment Research
Additionally, the valve system will be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates andstrong hemodynamic performance,along with unrestricted coronary access for future procedures. Per a BSX representative, the ACURATE valve platform has been implanted in nearly 80,000 patients globally to date.
The company plans to launch the system in Europe in the coming weeks. The ACURATE neo2 Aortic valve system and the ACURATE Prime Aortic valve system have both earned the CE mark in Europe. However, in the United States, these are investigational devices and are restricted under federal law to investigational use only.
Prospects in the TAVR Market for BSX
Per a Grand View Research report, the global TAVR market was valued at $6.3 billion in 2023 and is projected to witness a compound annual growth rate (CAGR) of 7.2% by 2030. Several factors drive the demand for TAVR, including the rising prevalence of aortic valve stenosis, increasing preference for minimally invasive procedures and the expanding geriatric population. Innovations in valve design, imaging techniques and catheter technologies have improved the safety, efficacy and accessibility of TAVR, contributing to the upward growth trend.
Recent Updates Within BSX’s Cardiology Segment
Boston Scientific’s second-quarter 2024 financial report, released last month, showcased robust organic growth in the Cardiology business. Within Interventional Cardiology Therapies, growth in coronary therapies was driven by the continued strength in its global Imaging portfolio and Asia-Pacific Calcium business. The Structural Heart Valves franchise benefited from the increasing demand for Accurate neo2 in Europe and Latin America. In addition, WATCHMAN reported a strong contribution from the ongoing launch of the WATCHMAN FLX Pro in the United States and Japan.
In the Cardiac Rhythm Management business, the Diagnostic franchise outpaced the market driven by a broad cardiac diagnostic portfolio. The Electrophysiology business performed remarkably well due to the rapid adoption of the FARAPULSE Pulsed Field Ablation System. Strong sales were driven by solid commercial execution, robust supply, positive real-world outcomes and higher atrial fibrillation ablation volumes supported by the efficiency of the FARAPULSE workflow.
BSX Stock Price Performance
In the past year, BSX shares have rallied 46.5% compared with the industry’s rise of 12.7%.
BSX’s Estimate Trend and EPS Surprise
In the past 30 days, estimates for Boston Scientific’s 2024 earnings have remained constant at $2.40. The company beat estimates in each of the trailing four quarters, the average surprise being 7.2%.
BSX’s Zacks Rank & Other Top MedTech Stocks
Boston Scientific currently carries a Zacks Rank #2 (Buy).
Exact Sciences’ shares have declined 26.2% in the past year. Estimates for the company’s loss per share have improved from $1.09 to 95 cents in 2024 and from 26 cents to 6 cents in 2025 in the past 30 days. EXAS’ earnings beat estimates in three of the trailing four quarters and matched in one, delivering an average surprise of 56.2%. In the last reported quarter, it posted an earnings surprise of 75.7%.
Estimates for AxoGen’s 2024 loss per share have narrowed to 1 cent from 19 cents in the past 30 days. Shares of the company have surged 98% in the past year compared with the industry’s growth of 8.7%. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.
Estimates for SiBone’s 2024 loss per share have narrowed to 89 cents from 95 cents in the past 30 days. Shares of the company have dropped 23% in the past year against the industry’s 11.4% growth. SIBN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.4%. In the last reported quarter, it delivered an earnings surprise of 15.4%.
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Boston Scientific's ACURATE Prime Aortic Valve System Wins CE Mark
Boston Scientific, Inc. (BSX - Free Report) has obtained a CE Mark for the ACURATE Prime Aortic Valve System — the newest transcatheter aortic valve replacement (TAVR) technology in its structural heart portfolio. The system builds upon the clinical performance of the ACURATE neo2 platform, featuring several enhancements, including an additional valve size, which expands the treatment range to patients with a larger anatomy.
The latest development is expected to boost the company’s Interventional Cardiology Therapies, a component of its Cardiology unit.
Significance of Boston Scientific’s Newest TAVR Option
The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes forces across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes.
The ACURATE Prime technology offers physicians a TAVR approach to streamline procedural preparation, improve performance in complex cases and simplify delivery for quick and controlled deployment. Clinical experience with the valve has demonstrated its ability for precise positioning across a broader population of patients, enabling more clinicians to consider this technology for treatment in challenging or larger heart structures.
Image Source: Zacks Investment Research
Additionally, the valve system will be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates andstrong hemodynamic performance,along with unrestricted coronary access for future procedures. Per a BSX representative, the ACURATE valve platform has been implanted in nearly 80,000 patients globally to date.
The company plans to launch the system in Europe in the coming weeks. The ACURATE neo2 Aortic valve system and the ACURATE Prime Aortic valve system have both earned the CE mark in Europe. However, in the United States, these are investigational devices and are restricted under federal law to investigational use only.
Prospects in the TAVR Market for BSX
Per a Grand View Research report, the global TAVR market was valued at $6.3 billion in 2023 and is projected to witness a compound annual growth rate (CAGR) of 7.2% by 2030. Several factors drive the demand for TAVR, including the rising prevalence of aortic valve stenosis, increasing preference for minimally invasive procedures and the expanding geriatric population. Innovations in valve design, imaging techniques and catheter technologies have improved the safety, efficacy and accessibility of TAVR, contributing to the upward growth trend.
Recent Updates Within BSX’s Cardiology Segment
Boston Scientific’s second-quarter 2024 financial report, released last month, showcased robust organic growth in the Cardiology business. Within Interventional Cardiology Therapies, growth in coronary therapies was driven by the continued strength in its global Imaging portfolio and Asia-Pacific Calcium business. The Structural Heart Valves franchise benefited from the increasing demand for Accurate neo2 in Europe and Latin America. In addition, WATCHMAN reported a strong contribution from the ongoing launch of the WATCHMAN FLX Pro in the United States and Japan.
In the Cardiac Rhythm Management business, the Diagnostic franchise outpaced the market driven by a broad cardiac diagnostic portfolio. The Electrophysiology business performed remarkably well due to the rapid adoption of the FARAPULSE Pulsed Field Ablation System. Strong sales were driven by solid commercial execution, robust supply, positive real-world outcomes and higher atrial fibrillation ablation volumes supported by the efficiency of the FARAPULSE workflow.
BSX Stock Price Performance
In the past year, BSX shares have rallied 46.5% compared with the industry’s rise of 12.7%.
BSX’s Estimate Trend and EPS Surprise
In the past 30 days, estimates for Boston Scientific’s 2024 earnings have remained constant at $2.40. The company beat estimates in each of the trailing four quarters, the average surprise being 7.2%.
BSX’s Zacks Rank & Other Top MedTech Stocks
Boston Scientific currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are Exact Sciences (EXAS - Free Report) , AxoGen (AXGN - Free Report) and SiBone (SIBN - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.
Exact Sciences’ shares have declined 26.2% in the past year. Estimates for the company’s loss per share have improved from $1.09 to 95 cents in 2024 and from 26 cents to 6 cents in 2025 in the past 30 days. EXAS’ earnings beat estimates in three of the trailing four quarters and matched in one, delivering an average surprise of 56.2%. In the last reported quarter, it posted an earnings surprise of 75.7%.
Estimates for AxoGen’s 2024 loss per share have narrowed to 1 cent from 19 cents in the past 30 days. Shares of the company have surged 98% in the past year compared with the industry’s growth of 8.7%. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.
Estimates for SiBone’s 2024 loss per share have narrowed to 89 cents from 95 cents in the past 30 days. Shares of the company have dropped 23% in the past year against the industry’s 11.4% growth. SIBN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.4%. In the last reported quarter, it delivered an earnings surprise of 15.4%.