Cordis’ Selution SLR Drug-Eluting Balloon Receives US FDA Approval for In-Stent Restenosis

Shots:

• The US FDA has approved the Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR)
• Approval was supported by data from the SELUTION4ISR trial assessing Selution SLR DEB vs SoC, incl. 80% drug-eluting stents, in pts (n >400) with coronary ISR across the US, Canada, Brazil, & Europe
• The study met its 1EP, showing non-inferiority to SoC in the target populationat 12mos., with target lesion failure rates of 15.2% vs 13.5%

Ref:  Businesswire  |   Image: Cordis  |  Press Release

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