Boston Scientific Corporation (NYSE: BSX), a leading medical device manufacturer in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Agent paclitaxel coated PTCA balloon catheter (AGENT DCB). This product is designed for the treatment of coronary in-stent restenosis (ISR) and is the world’s first such product to receive both a CE mark and a China marketing nod.
The AGENT DCB is innovatively designed to navigate and treat complex distal lesions. Its efficacy was demonstrated in a multicenter, prospective, randomized controlled AGENT IDE study involving 600 patients. The study results indicated that the target lesion failure rate for the Agent DCB group was significantly lower than that of the uncoated balloon angioplasty group at 12 months post-surgery (17.9% vs. 28.6%, P=0.003).- Flcube.com
