Surmodics Sundance Sirolimus DCB Evaluated in 24-Month SWING Data

November 16, 2023—Surmodics, Inc. announced 24-month data from the SWING trial, a first-in-human study of the company’s Sundance sirolimus drug-coated balloon (DCB). The prospective, multicenter, single-arm, feasibility study is evaluating the safety and performance of the Sundance DCB in treating occlusive disease of the infrapopliteal arteries.

Professor Ramon Varcoe, MBBS, presented the findings at the 50th annual VEITHsymposium held November 14-18 in New York, New York. Prof. Varcoe and Professor Andrew Holden, MBChB, are colead investigators of the SWING trial.

According to the company, the SWING trial enrolled 35 patients with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2 to 4 mm, and a total lesion length ≤ 230 mm for treatment with the Sundance sirolimus DCB at eight sites in Australia, New Zealand, and Europe. Patients in the study will be followed for 36 months post–index procedure.

The primary safety endpoint is defined as the number of patients with a composite of freedom from major adverse limb events and perioperative death at 30 days after the index procedure. The primary efficacy endpoint is the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography.

The trial achieved both primary endpoints.

As summarized in the company’s press release, the primary safety endpoint data showed no perioperative deaths or major amputations at 30 days. One major reintervention was reported among the 35 trial patients. In the per-protocol (PP) population, there was 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 patients in the 12- or 24-month data.

The primary efficacy data showed late lumen loss of 1.0 mm (± 0.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained postprocedure.

The target lesion primary patency rate was 71.4% at 24 months in the PP population. Target lesion primary patency was defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration of Rutherford class and/or increase in size of pre-existing wounds (or occurrence of new wounds) and lesion restenosis > 50%.

“The 2-year safety and performance results of the SWING trial continue to show promise for the Sundance sirolimus DCB in treating below-the-knee disease in a challenging chronic limb-threatening ischemia patient population where options are currently limited,” commented Prof. Holden in the Surmodics press release. Prof. Holden is Director of Northern Region Interventional Radiology Service at Auckland City Hospital in Auckland, New Zealand.

Prof. Varcoe added, “We need to continue to strive for better treatments for treating infrapopliteal disease. These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.” Prof. Varcoe is a vascular surgeon at Prince of Wales Hospital in Sydney, Australia, where he is Director of Operating Theatres and Director of Surgery and Anesthetics for the South East Sydney Health District.