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First US patient enrolled in below-the-knee trial for DCB

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Philips announced that the first U.S. patient has been enrolled in the investigational device exemption trial of its drug-coated balloon designed to treat below-the-knee lesions.

The trial, ILLUMENATE BTK, will compare the DCB (Stellarex 0.014) to percutaneous transluminal angioplasty in patients with critical limb ischemia, according to a press release issued by the company.

The company stated that the investigators plan to enroll 354 patients at 45 sites in the U.S., Australia and Europe in the next 12 to 18 months.

“Several studies have shown the safety and durability benefits of the Stellarex balloon,” Mahmood K. Razavi, MD, FSIR, FSVM, from St. Joseph’s Hospital in Orange, California, co-principal investigator of the trial, said in the release. “This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK peripheral artery disease (PAD) and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation.”

The first U.S. patient was enrolled at the Cardiovascular Institute of the South in Houma, Louisiana, by Craig Walker, MD.

The device has a CE mark for use in Europe but is not yet approved for use in the United States.

Disclosure: Razavi reports he has consulted for Abbott Vascular, Biomet/Zimmer, Boston Scientific, Medtronic, Mercator Medsystems, Philips/Spectranetics, Terumo/Microvention and Veniti.