DCB approved to treat US patients with PAD
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Spectranetics announced that the FDA approved its drug-coated balloon for endovascular treatment of patients with peripheral artery disease and superficial femoral or popliteal lesions.
The DCB (Stellarex) is the third approved for this indication in the United States. Approval was based on the results of the ILLUMENATE pivotal trial, which demonstrated high rates of patency and low rates of clinically driven target lesion revascularization in patients with a wide range of lesion complexity and comorbidities, according to a company press release.
“The Stellarex DCB has shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics and core-lab defined severely calcified lesions in the U.S. [investigational device exemption] trial,” Prakash Krishnan, MD, FACC, FSCAI, associate professor of medicine at Icahn School of Medicine at Mount Sinai and the co-principal investigator of the ILLUMENATE trial, said in the release. “These results, in combination with the cohort of patients studied in the European randomized controlled trial, demonstrate the Stellarex DCB is safe and effective in diverse patient populations when addressing symptomatic femoropopliteal disease.”
According to the release, the DCB’s hybrid paclitaxel crystallinity and durable excipient enable efficient drug transfer, enabling treatment with a low dose of paclitaxel.
Disclosure: Krishnan reports financial ties with Abbott Laboratories, C.R. Bard, Medtronic and Spectranetics.