Boston Scientific Reports the US FDA’s Approval of AGENT Drug-Coated Balloon (DCB) to Treat Coronary In-Stent Restenosis (ISR)
Shots:
- The US FDA has approved AGENT DCB, a paclitaxel-coated balloon catheter, for treating coronary in-stent restenosis (ISR) in coronary artery disease patients based on the AGENT IDE study (n=600) of the device vs balloon angioplasty across the US
- The study’s prespecified interim analysis in the first 480 patients showed failure in the target lesion (TLF) at 12mos. with superiority in 17.9% vs 28.7% patients, definite/probable cases of clotting within the stent were 0.0% vs 3.9% & a 49% risk reduction in heart attack at the target vessel was seen in 6.4% vs 12.3%
- The AGENT DCB is available in the EU, certain Asia Pacific regions & Latin America while the US launch is anticipated in the coming months
Ref: Boston Scientific | Image: Boston Scientific
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
