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# Boston Scientific Ranger Balloon OK’d for PAD
- URL: https://www.fdaweb.com/boston-scientific-ranger-balloon-okd-for-pad/
- Published: 2020-11-02T12:00:00.000Z
- Updated: 2026-09-14T16:34:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147999

FDA has approved Boston Scientific’s Ranger Drug-Coated Balloon for treating patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The company says the device was designed with a “low therapeutic drug dose and proprietary coating which efficiently transfers the drug into the tissue, resulting in high primary patency rates and low systemic drug exposure for patients.” Its low-profile platform of the balloon also assists clinicians in performing streamlined procedures and navigating through challenging anatomy in order to deliver consistent therapy, it says.

Approval was based on results from the RANGER II SFA pivotal trial, which evaluated the safety and effectiveness of the device versus standard percutaneous transluminal angioplasty (PTA) for treating patients with PAD in the SFA and PPA. In the randomized controlled trial, both primary endpoints were met. The primary safety endpoint of 12-month freedom from major adverse events was 94.1% for those treated with the Ranger DCB versus 83.5% for standard PTA, the company says. The primary efficacy endpoint of 12-month binary primary patency – a measure of the target vessel remaining unobstructed – was 82.9% for the Ranger DCB and 66.3% for standard PTA.