Saturday, April 20, 2024

Drug-Coated Balloon for In-Stent Restenosis Treatment by Boston Scientific Gets from FDA Green Light

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Boston Scientific has secured a significant win with the Food and Drug Administration (FDA) approval of its drug-coated balloon, a novel tool for treating coronary in-stent restenosis (ISR). This condition arises when a previously placed stent in a coronary artery narrows again due to plaque buildup or scar tissue.

Coronary artery disease (CAD) remains a leading cause of death and disability worldwide. It develops when fatty deposits build up inside the coronary arteries, the vessels responsible for delivering oxygen-rich blood to the heart muscle. This plaque buildup narrows the arteries, restricting blood flow and potentially leading to chest pain, shortness of breath, and even heart attack.

One of the mainstays of treatment for CAD is percutaneous coronary intervention (PCI). During a PCI procedure, a cardiologist inserts a thin, flexible tube into a blocked artery. A tiny balloon at the tip of the catheter is then inflated to open the blockage. Often, a stent, a small expandable metal tube, is placed within the artery to prop it open and prevent it from re-narrowing.

Boston Scientific Unveils a Drug-Coated Balloon to Revolutionize In-Stent Restenosis Treatments

While stenting offers a life-saving solution for many CAD patients, a significant challenge called in-stent restenosis can arise. ISR occurs when scar tissue or new plaque accumulation develops within or around the implanted stent, causing the artery to narrow once again. Studies suggest that roughly 10% of patients in the U.S. who undergo PCI experience in-stent restenosis within a year. This re-narrowing can lead to similar symptoms as the original blockage, putting patients at renewed risk of heart attack and other complications.

When in-stent restenosis occurs, cardiologists face a dilemma. Several treatment options exist, but each carries limitations: This approach involves re-inflating the balloon within the stented artery to try and widen the blockage. While minimally invasive, it may not be as effective as the initial procedure and carries a risk of further damaging the vessel wall. Placing another stent inside the existing one can sometimes re-establish blood flow. However, this increases the amount of foreign material in the artery and can potentially lead to future complications like stent thrombosis (blood clot formation within the stent). In some cases, radiation therapy may be used to prevent scar tissue growth from narrowing the stent. However, radiation carries potential side effects on surrounding tissues.

Boston Scientific’s Agent drug-coated balloon offers a promising alternative to traditional methods for treating in-stent restenosis. These methods include balloon angioplasty (re-inflating the balloon), adding more stents, or radiation therapy. The Agent balloon is coated with paclitaxel, a drug that helps prevent the vessel wall from narrowing again after treatment.

In-Stent Restenosis

Boston Scientific’s Agent Balloon Secures FDA Approval, Pioneering In-Stent Restenosis Therapy

The FDA approval was based on positive results from the Agent trial, a robust study enrolling 600 patients across 40 U.S. sites. The balloon demonstrated statistically significant superiority compared to uncoated balloon angioplasty. Notably, the Agent balloon achieved a 38% relative risk reduction in the primary endpoint (target lesion failure) at one year, highlighting its effectiveness.

Analysts project the Agent balloon to become a significant player in the global market, with Boston Scientific estimating a potential value of $500 million. Additionally, the company sees further expansion opportunities beyond the initial in-stent restenosis indication, potentially reaching a $1 billion market.

The FDA approval of Boston Scientific’s Agent drug-coated balloon marks a significant advancement in treating ISR. With its demonstrated effectiveness and potential for wider application, the Agent balloon is poised to become a valuable tool for cardiologists and improve patient outcomes. The coming months will see the launch of the Agent balloon in the U.S., offering new hope for patients struggling with ISR.


Resource: Med Tech Dive, March 01, 2024

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