MARLBOROUGH, Mass. - Boston Scientific Corporation (NYSE:BSX) announced today the U.S. Food and Drug Administration (FDA) has approved its AGENT Drug-Coated Balloon (DCB) for treating coronary in-stent restenosis (ISR), a condition characterized by the narrowing of a stented vessel due to plaque or scar tissue. This marks the introduction of the first drug-coated coronary balloon in the United States.
The AGENT DCB is designed to deliver a therapeutic dose of the drug paclitaxel to the vessel wall, aiming to prevent the reoccurrence of ISR. It serves as an alternative to other treatments like balloon angioplasty, additional stenting, or radiation.
The FDA's approval follows the positive outcomes from the AGENT IDE clinical trial, which involved 600 patients across 40 U.S. sites. The interim analysis of the first 480 patients showed the AGENT DCB to be statistically superior to uncoated balloon angioplasty in reducing target lesion failure (TLF) at 12 months. The trial also reported zero cases of definite/probable stent thrombosis and a 49% reduction in heart attack risk at the target vessel with the AGENT DCB.
Dr. Robert W. Yeh, the principal investigator of the trial, highlighted the effectiveness and safety of the AGENT DCB, especially in high-risk populations, including individuals with multi-layer stents or diabetes. He emphasized the importance of this new technology in providing physicians with an additional option to treat ISR without radiation or adding more metal layers.
Boston Scientific has already made the AGENT DCB available in Europe, parts of Asia Pacific, and Latin America for the treatment of ISR and previously untreated small vessel coronary disease. The company plans to launch the technology in the U.S. market in the coming months.
This news is based on a press release statement from Boston Scientific Corporation.
InvestingPro Insights
Boston Scientific Corporation (NYSE:BSX) has recently celebrated a significant milestone with the FDA approval of its AGENT Drug-Coated Balloon, a treatment set to impact the coronary in-stent restenosis market. As investors and stakeholders look to understand the potential financial implications of this development, InvestingPro provides valuable insights into the company's financial health and market position.
InvestingPro Data highlights Boston Scientific's robust market capitalization of $97.14 billion, underscoring the company's significant presence in the healthcare equipment and supplies industry. The data also reveals a P/E Ratio of 61.68, which, when adjusted for the last twelve months as of Q4 2023, stands at 58.04. This P/E ratio is relatively high, indicating that investors may expect substantial earnings growth in the near term, which aligns with the company's latest innovation in coronary treatment.
One of the key InvestingPro Tips for Boston Scientific is the anticipation of net income growth this year, which could be fueled by the introduction of the AGENT DCB in the U.S. market. Additionally, the company is recognized as a prominent player in its industry, which may provide a competitive edge as it rolls out this new technology. However, it's worth noting that 11 analysts have revised their earnings expectations downwards for the upcoming period, suggesting that investors should keep a close eye on the company's performance relative to these projections.
For those seeking a more in-depth analysis, InvestingPro offers additional tips, including insights on the company's valuation multiples, debt levels, and stock volatility. With 15 additional InvestingPro Tips available at https://www.investing.com/pro/BSX, investors can gain a comprehensive understanding of Boston Scientific's financial landscape.
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