Coronary drug-coated medical device receives US FDA approval

Boston Scientific announced the FDA approval of their medical device AGENT Drug-Coated Balloon (DCB) for the indication of coronary in-stent restenosis in coronary artery disease patients.  

Though stenting has contributed to a significant improvement in quality of life for coronary artery disease patients, ISR continues to occur in 10% of percutaneous coronary interventions in the US. Traditional therapies include balloon angioplasty, more layers of stenting, or radiation. The AGENT DCB offers an alternative through the transfer of a therapeutic dose of paclitaxel to the vessel wall through a balloon coated in the drug, helping to prevent ISR reoccurrence.  

Lance Bates, President, Interventional Cardiology Therapies at Boston Scientific commented in a press release: “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 US. 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 US physicians the opportunity to treat their patients with this novel device.” 

Currently, the AGENT DCB is available in Europe and certain part of the APAC and LATAM regions for the treatment of ISR and untreated small vessel coronary disease. Principal investigator Robert W Yeh, Section Chief of interventional cardiology at the Beth Israel Deaconess Medical Center stated in a press release: “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. Treating ISR has been challenging in the US 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.” 

Source 

Boston Scientific Receives FDA Approval for the AGENTTM Drug-Coated Balloon [Accessed March 4, 2024] https://news.bostonscientific.com/2024-03-01-Boston-Scientific-Receives-FDA-Approval-for-the-AGENT-TM-Drug-Coated-Balloon