Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA

November 4, 2020 Auto Bot approval, Boston Scientific, MedTech, patients, receives, Treatment, Us FDA 0

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

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: Forbes

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