Shots:

• The approval is based on the RANGER II SFA pivotal study assessing the Ranger DCB vs standard PTA for the treatment in patients with PAD in the SFA & PPA
• The study met its both 1EPs @12mos. i.e. MAE (94.1% vs 83.5%); lesion revascularization rate (5.5% vs 16.5%); Binary primary patency (82.9% vs 66.3%); primary patency by Kaplan-Meier estimate (89.8% vs 74.0%). The DCB has demonstrated 90% primary patency in COMPARE trial
• The company expects to initiate a registry of the Ranger DCB and the Eluvia stent in the coming months to gather additional RWE and plans to launch the device in the US

  Ref: PRNewswire | Image: Forbes