FDA Okays Two Stellarex DCBs for Peripheral Artery Disease

Patrice Wendling

October 15, 2019

The 200 mm and 150 mm Stellarex 0.035 low-dose paclitaxel-coated balloons (Philips) have received US Food and Drug Administration (FDA) approval for the treatment of de novo and restenotic lesions in superficial femoral and popliteal arteries, the company announced today.

Stellarex drug-coated balloons (DCBs) feature a coating containing a polyethylene glycol excipient with amorphous and crystalline paclitaxel particles that "provides efficient drug transfer and effective drug residency coupled with high coating durability and minimal particulate loss, thereby enabling a low therapeutic drug dose," according to Philips.

The Stellarex balloon is now available in 40, 60, 80, 100, 120, 150, and 200 mm lengths to treat lesions in arteries with vessel diameters of 4 to 6 mm.

The safety of paclitaxel-coated devices to treat peripheral artery disease (PAD) has been the subject of intense scrutiny following a December 2018 meta-analysis by Katsanos and colleagues that identified an increased mortality risk beginning at 2 years with paclitaxel-coated balloon and stents versus uncoated devices.

The findings prompted a host of new research including a preliminary analysis by the FDA that found an approximate 50% increased mortality risk in persons treated with paclitaxel-coated devices at 5 years. An FDA advisory committee hosted a 2-day meeting this summer to address the controversy and suggested that labeling of paclitaxel-coated balloons and stents should reflect current evidence linking the devices to a late mortality signal.

A recent, independently performed patient-level meta-analysis of the ILLUMENATE trial program showed no difference in mortality at 3 years between patients with femoropopliteal artery disease treated with Stellarex paclitaxel-coated balloons in lengths less than 150 mm and those treated with percutaneous angioplasty, Philips noted in the release.

"We've already implemented the labeling updates requested by the FDA for our Stellarex portfolio, including for these new balloons," Philips senior press officer Mark Groves told theheart.org | Medscape Cardiology.

The label includes a brief statement on and overview of the available evidence, as well as a recommendation that physicians "discuss the late mortality signal and the benefits and risks of available treatment options with their patients."

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