MARLBOROUGH, Mass. – Boston Scientific Corporation (NYSE: NYSE:BSX) today disclosed the primary endpoint results from its ACURATE IDE clinical trial, which assessed the ACURATE neo2™ Aortic Valve System for patients with severe aortic stenosis across various surgical risk categories. The findings were unveiled during the Transcatheter Cardiovascular Therapeutics® (TCT®) 2024 symposium.
The trial, which compared the second-generation ACURATE neo2 valve to a control valve—either the SAPIEN™ valve or the Evolut™ transcatheter aortic valve—did not meet the prespecified threshold for non-inferiority. The one-year composite rate of mortality, stroke, or rehospitalization was 16.16% for the ACURATE neo2 group, against 9.53% for the control group, with a posterior probability for non-inferiority at 77.9%, below the required 97.5%.
Michael Reardon, M.D., of Houston Methodist DeBakey Heart & Vascular Center, and co-principal investigator of the trial, emphasized the trial's scale and the insights it provides for procedural optimization in transcatheter aortic valve replacement (TAVR).
An additional post-hoc analysis within the trial indicated that around 20% of the ACURATE neo2 valves were under-expanded. However, when proper valve expansion was achieved, the outcomes were comparable to the control group.
Janar Sathananthan, M.D., chief medical officer at Boston Scientific's Interventional Cardiology Therapies, commented on the significance of procedural refinement for improving TAVR outcomes and indicated that future trials would incorporate these enhancements.
While the ACURATE neo2 Aortic Valve System is CE-marked in Europe, it remains investigational in the U.S., with ongoing discussions with the FDA regarding its approval strategy.
Boston Scientific, a pioneer in medical technology, focuses on developing solutions that address patient needs and reduce healthcare costs. This report is based on a press release statement.
In other recent news, Boston Scientific has been making significant strides in its business operations. The company reported an impressive 18% year-over-year organic growth in its third-quarter financial results, surpassing market expectations. This robust performance also led to a 26% year-over-year increase in earnings per share. In light of these results, Boston Scientific revised its 2024 guidance upwards, forecasting a 15% organic sales growth by year-end.
The company also announced an upcoming acquisition of Axonics, indicating a commitment to expanding its capacity and efficiency across various medical segments. Meanwhile, TD Cowen maintained its Buy rating and $100.00 price target for Boston Scientific, following evaluation of issues surrounding the Farawave catheter's insertion process. Similarly, RBC Capital Markets increased its price target for Boston Scientific to $98, reaffirming its Outperform rating on the stock, while CL King maintained its Buy rating with a steady price target of $90.00.
These recent developments underscore Boston Scientific's ongoing initiatives and strong performance. The company is anticipating 14% to 16% organic growth in the fourth quarter and expects full-year reported revenue growth to be around 16.5%.
InvestingPro Insights
Despite the setback in the ACURATE IDE clinical trial, Boston Scientific Corporation (NYSE: BSX) remains a formidable player in the healthcare equipment and supplies industry. According to InvestingPro data, the company boasts a substantial market capitalization of $121.04 billion, reflecting its significant presence in the medical technology sector.
The company's financial performance has been robust, with revenue growth of 15.66% over the last twelve months as of Q3 2024, reaching $15.91 billion. This growth trajectory aligns with an InvestingPro Tip indicating that net income is expected to grow this year. Additionally, the company's gross profit margin stands at an impressive 68.95%, underscoring its operational efficiency.
Investors should note that BSX is trading near its 52-week high, with a strong one-year price total return of 68.95%. This performance is consistent with another InvestingPro Tip highlighting the company's high return over the last year. However, potential investors should be aware that the stock is trading at a high P/E ratio of 68.41, which may suggest a premium valuation.
For those seeking a more comprehensive analysis, InvestingPro offers 17 additional tips for Boston Scientific, providing a deeper understanding of the company's financial health and market position. These insights could be particularly valuable in light of the recent clinical trial results and their potential impact on the company's future prospects in the TAVR market.
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