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Boston Scientific (BSX) Posts Positive Post-Market Study Data

Boston Scientific Corporation BSX recently announced the first results from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study, which evaluated the performance of the ACURATE neo2 Aortic Valve System. The favorable findings were presented during a late-breaking clinical trial session at PCR London Valves 2022 and were published simultaneously in EuroIntervention.

The ACURATE neo2 Aortic Valve System, which received the CE Mark in 2020, is being assessed in the currently enrolling ACURATE Investigational Device Exemption trial in the United States and Canada. However, the system is an investigational device and not available for sale in the United States.

The latest positive PMCF study outcome of ACURATE neo2 Aortic Valve System in patients is a significant stepping stone for Boston Scientific’s Structural Heart Therapies business (under the broader Cardiovascular segment) across the world.

Significance of the Result

Per Boston Scientific, the primary safety endpoint of all-cause mortality was very low at 30 days in this European study. The data also demonstrated that paravalvular leak (PVL) in patients were lower side.

Per an expert associated with the PMCF study, the foundational data set now presents post-market surveillance results that validate the use of the current-generation ACURATE neo2 valve for the management of patients with severe aortic stenosis. The expert also added that the data suggest that the annular sealing technology of the current-generation ACURATE neo2 valve will likely minimize leakage around the valve, thus providing greater improvement in PVL than with the prior-generation ACURATE neo valve.

The current-generation neo valve will also likely maintain single-digit permanent pacemaker rates, thereby leading to improved long-term patient outcomes.

Per management, the trial data illustrate the success of meaningful and differentiated enhancements included in the design of the ACURATE neo2 valve, which includes low rates of PVL, excellent hemodynamic performance and high rates of procedural success and safety, among others.

Industry Prospects

Per a report by Blueweave Consulting, the global structural heart devices market was worth $11.63 billion in 2021 and is anticipated to reach $24.16 billion by 2028 at a CAGR of 11.2%. Factors like the increase in the number of life-threatening heart diseases and technological advancements in medical devices are likely to drive the market.

Given the market potential, the latest positive study outcome is likely to provide a significant boost to Boston Scientific’s business globally.

Notable Developments in Cardiovascular Arm

Last month, Boston Scientific announced its third-quarter 2022 results, where it registered better-than-expected revenues. The company also registered a year-over-year improvement in organic sales, indicating a strong rebound in the legacy business amid several macroeconomic issues.

The Cardiovascular segment also recorded robust revenue improvement, where sales from its sub-segments, Cardiology and Peripheral Interventions, were solid.

In September, Boston Scientific announced results from the PROTECTED TAVR (transcatheter aortic valve replacement) clinical trial evaluating the SENTINEL Cerebral Protection System. The outcomes were presented during a late-breaking clinical science session at the Transcatheter Cardiovascular Therapeutics in Boston.

Also in September, Boston Scientific received the FDA’s approval to expand the instructions for use labeling for the current-generation WATCHMAN FLX Left Atrial Appendage Closure Device to include a 45-day dual anti-platelet therapy option as an alternative to 45-day oral anticoagulation plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation.

Price Performance

Shares of the company have gained 14.4% in the past year against the industry’s 43.8% decline and the S&P 500's 15.1% fall.

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Zacks Rank & Key Picks

Currently, Boston Scientific carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. AMN, ShockWave Medical, Inc. SWAV and McKesson Corporation MCK.

AMN Healthcare, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 3.3%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 10.9%.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AMN Healthcare has gained 5.9% against the industry’s 31.2% decline in the past year.

ShockWave Medical, carrying a Zacks Rank #2 at present, has an estimated growth rate of 23.6% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 146.1%.

ShockWave Medical has gained 45.4% against the industry’s 25.2% decline over the past year.

McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.1%. MCK’s earnings surpassed estimates in two of the trailing four quarters and missed the same in the other two, the average beat being 4.8%.

McKesson has gained 71.7% against the industry’s 8.9% decline over the past year.

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