The U.S. Food and Drug Administration (FDA) has approved the AGENT drug-coated balloon (DCB) to treat coronary in-stent restenosis (ISR), marking the first time a DCB is available for commercial use in the U.S. Boston Scientific Corp., the device’s manufacturer, announced the approval in a news release issued Friday. DCBs have been commercially available in Europe for 15 years, but until now, U.S. clinicians were only able to use them in FDA-approved premarketing trials. “With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S,” said Lance Bates, the president of Interventional Cardiology Therapies at Boston Scientific, in the news release. “The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering U.S. physicians the opportunity to treat their patients with this novel device.” The FDA had granted the DCB the Breakthrough Device Designation in 2021. The approval comes after the preliminary results of the AGENT investigational device exemption (IDE) randomized trial showed that the paclitaxel-coated balloon was superior to plain old balloon angioplasty (POBA) in treating coronary ISR lesions. These results were released at the Transcatheter Cardiovascular Therapeutics (TCT) conference in October In the trial, the primary endpoint was target lesion failure (TLF), defined as the composite of recurrent ISR, target vessel myocardial infarction or cardiac-related death at 1 year. The news release issued Friday said the rate of TLF at 1 year was 17.9% in the DCB arm and 28.7% in the POBA arm (p=0.006). The interim trial results also no definite or probably stent thrombosis in the device arm compared to 3.9% in the POBA arm (p=0.001), a 49% reduction of target vessel myocardial infarction (6.4% vs. 12.3%, p=0.03), and low rates of adverse events at 1 year. “The AGENT IDE trial demonstrated that the AGENT DCB is an effective and safe treatment option for coronary in-stent restenosis, even in a high-risk population, which included many individuals with multi-layer stents or diabetes,” said principal investigator Robert W. Yeh, MD, the section chief of interventional cardiology at the Beth Israel Deaconess Medical Center, Boston, in the news release. “Treating ISR has been challenging in the U.S. with limited therapies available, and this new technology will help physicians reduce the risk of restenosis without radiation or introducing additional metal layers, which do not provide an adequate result for some patients.” Boston Scientific said it plans to market the device in the U.S. “in the coming months.” Image Credit: Courtesy of Boston Scientific Corp.