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# Surmodics Drug-Coated Balloon Approved
- URL: https://www.fdaweb.com/surmodics-drug-coated-balloon-approved/
- Published: 2023-06-20T12:00:00.000Z
- Updated: 2026-09-14T18:39:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154724

FDA has approved Surmodics’ SurVeil drug-coated balloon (DCB) and its use in percutaneous transluminal angioplasty. The device is intended to be used for treating *de novo* or restenotic lesions (less than 180 mm in length) in femoral and popliteal arteries having reference vessel diameters of 4 mm to 7 mm.

Approval is based on 24-month clinical trial data showing that the device remained non-inferior to Medtronic’s IN.PACT Admiral DCB at a substantially lower drug dose (paclitaxel). Surmodics says data showed that at 24 months, 81.8% of subjects treated with the SurVeil DCB “met the secondary safety endpoint, a composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically driven target vessel revascularization (CD-TVR) vs. 83.2% of subjects treated with the IN.PACT Admiral DCB.” Less than 15% of patients in both arms of the trial required repeat revascularization procedures, it added.

Surmodics says that Abbott has exclusive worldwide commercialization rights for the SurVeil DCB.