Boston Scientific's AGENT Paclitaxel-Coated PTCA Balloon Catheter Receives NMPA Approval for In-Stent Restenosis Treatment in China

It is reported that the number of coronary heart disease patients in China has exceeded 11 million.^[2], and with the aging population and changes in people's lifestyles, this number continues to grow. Percutaneous coronary intervention (PCI), a common treatment for coronary heart disease, has also seen a continuous rise in clinical application. In the past, PCI mainly involved the implantation of coronary artery stents to alleviate symptoms of coronary heart disease caused by vascular stenosis. However, in-stent restenosis due to complex reasons has severely affected the long-term prognosis of patients, becoming a major clinical challenge that needs urgent resolution.^[3]。

Drug-coated balloons, which do not leave permanent implants in the body, are considered another treatment strategy for PCI.^[2]The surface of the drug-coated balloon is covered with a layer of anti-proliferative drugs, whose active ingredients can rapidly penetrate into the vascular wall within the duration of a single balloon expansion. This helps inhibit the proliferation and migration of smooth muscle cells, thereby impeding the restenosis process. In the United States, ISR issues still occur in 10% of PCI procedures.^[4], the use of DCB can transfer therapeutic doses of medication to the vessel wall, helping to prevent the recurrence of ISR. Currently, DCB has been proven effective in addressing ISR and de novo lesions in small coronary arteries (SVD).^[2]。

As a global innovator in minimally invasive interventional medical devices, Boston Scientific has deep technical expertise and a diverse product portfolio in the field of coronary intervention. Previously, multiple PCI solutions from Boston Scientific have been widely used in clinical applications in China, covering the entire process of PCI diagnosis and treatment. The newly approved AGENT DCB has been innovatively designed to reach and navigate through distal complex lesions. In the AGENT IDE study, a multicenter, prospective, randomized controlled trial involving 600 patients, results showed that the target lesion failure rate at 12 months post-procedure was lower in the AGENT DCB group compared to the uncoated balloon angioplasty group (17.9% vs. 28.6%, P=0.003).^[5]So far, more than 100,000 patients worldwide have received AGENT DCB treatment in clinical trials and commercial settings. With the official launch of this product in China, it will further enrich Boston Scientific's coronary intervention product portfolio, serving the health needs of a large number of coronary heart disease patients.