Surmodics, Inc. announced that 24-month data from the SWING Trial, a first-in-human study of the safety and performance of the Sundance?? Sirolimus Drug-Coated Balloon (DCB) was presented at the 50th annual VEITH Symposium in New York, New York. The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of theSundance Sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

The SWING Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteAL arteries, a reference vessel diameter of 2 mm to 4 mm, and a total lesion length of 230 mm for treatment with the Sundance Sirolimus DC B at eight sites in Australia, New Zealand, and/or Europe. Study subjects will be followed for 36 months post index procedure. The primary safety endpoint is defined as the number of subjects with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death at 30 days following the index procedure.

The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography. Both primary endpoints of the SWING Trial were achieved. Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and just one major re-intervention was reported among the 35 trial subjects.

The per protocol (PP) population reported an 8.3% rate of major adverse events (two clinically driven target limb revascularizations) at 6 months, with no additional adverse events reported for PP subjects in the 12 or 24-month data. Primary efficacy data show late lumen loss of 1.0 mm (+-.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained post procedure. Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration of Rutherford Clinical Classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >50%, was 71.4% at 24 months in the PP population.

The Rutherford Clinical Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings, and is used to assess disease progression.