The US Food and Drug Administration (FDA) has approved Boston Scientific's Ranger drug-coated balloon (DCB) for the treatment of peripheral artery disease, the company announced Monday.
The paclitaxel-coated balloon is indicated for percutaneous transluminal angioplasty of de novo or restenotic lesions up to 180 mm in length located in native superficial femoral and proximal popliteal arteries (SFA/PPA) with reference vessel diameters of 4 mm to 7 mm.
"The Ranger DCB 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," the release states.
The approval comes nearly 2 years after a meta-analysis from Greek researchers identified an increased mortality signal about 3 years after treatment with paclitaxel-coated balloons and stents, compared with non–drug-coated devices.
In 2019, the FDA called on device makers to revise their labels to reflect the mortality signal after its own assessment of randomized controlled trial data also showed a consistent late mortality signal.
Several device makers, however, have published postmarket studies showing no such added risk with DCB use in the periphery, including recent 4-year findings from the ILLUMENATE study of the Stellarex (Philips) DCB.
Still, the Ranger DCB label includes this warning: "There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients."
The approval is based on results from the RANGER II SFA trial, in which the primary safety endpoint of 12-month freedom from major adverse events was 94.1% of patients treated with the Ranger DCB and 83.5% of those treated with standard angioplasty (P for noninferiority, < .0001).
The primary efficacy endpoint of 12-month binary primary patency was 82.9% for the Ranger DCB and 66.3% for standard angioplasty (P = .0017). The 12-month clinically driven target lesion revascularization rate was 5.5% and 16.5%, respectively, the release notes.
In the COMPARE trial, the first head-to-head comparison of two DCBs, the Ranger DCB had a primary patency rate of 88.4%, vs 89.4% for the IN.PACT Admiral DCB (Medtronic), by Kaplan-Meier estimate (P = .81), but with a significantly lower paclitaxel dose density (2 µg/mm2 vs 3.5 µg/mm2).
Boston Scientific plans to launch a registry of the Ranger DCB and its Eluvia stent in the coming months. It will include 5-year patient follow-up with an emphasis on enrolling patient populations who have been historically underrepresented in PAD clinical trials, according to the release.
The Ranger DCB earned CE mark in 2014 and is expected to be launched immediately in the United States, the company noted.
Cite this: FDA Okays Ranger Drug-Coated Balloon for PAD - Medscape - Nov 04, 2020.