Low-dose DCB receives FDA approval to treat lesions in patients with PAD
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Key takeaways:
- A low-dose paclitaxel-coated balloon has been approved for treatment of lesions in patients with peripheral artery disease.
- The device was noninferior to a higher-dose balloon at 24 months.
Surmodics announced that the FDA has approved its low-dose paclitaxel-coated balloon for certain patients with peripheral artery disease.
The balloon (SurVeil) has a drug load of 2 µg/mm2, lower than the 3.5 µg/mm2 drug load of an existing device (IN.PACT Admiral, Medtronic), according to a press release from Surmodics.
Image: Adobe Stock
The device is indicated for percutaneous transluminal angioplasty after appropriate vessel preparation of de novo or restenotic lesions 180 mm or less in length in femoral and popliteal arteries with reference vessel diameters of 4 mm to 7 mm, according to the release.
The approval was based on the results of the TRANSCEND trial, in which, as Healio previously reported, the SurVeil balloon was noninferior to the IN.PACT Admiral balloon at 12 months; those results were sustained out to 24 months.
“I am excited that the Surveil DCB will be available to treat patients in the U.S.,” Kenneth Rosenfield, MD, MHCDS, FACC, FAHA, MSCAI, section head of vascular medicine and intervention at Massachusetts General Hospital and co-principal investigator of the TRANSCEND trial, said in the release. “The Surveil DCB is the next-generation DCB as established by results from the TRANSCEND trial, which is the only head-to-head pivotal study that has been conducted vs. the market-leading DCB. The Surveil DCB successfully demonstrated noninferior safety and effectiveness at 2 years posttreatment with a substantially lower drug dose.”
The product will be commercialized by Abbott, according to the release.
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