Surmodics Sundance Sirolimus DCB Evaluated at 12 Months in SWING Trial

November 17, 2022—Surmodics, Inc. announced the presentation of 12-month data from the SWING trial, a first-in-human study of the company’s Sundance sirolimus drug-coated balloon (DCB). The 35-patient prospective, multicenter, single-arm, feasibility study is evaluating the safety and performance of the Sundance DCB when used to treat occlusive disease of the infrapopliteal arteries.

Professor Ramon Varcoe, MBBS, Colead Investigator of the SWING trial, presented the findings at the 49th annual VEITHsymposium held November 15-19 in New York, New York.

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

The company stated that the primary efficacy and safety endpoints of the SWING trial were achieved.

As summarized in Surmodics’ press release, the study’s primary efficacy endpoint was defined as the rate of late lumen loss at 6 months, as assessed by quantitative vascular angiography. The data showed late lumen loss of 1 mm (± .79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained postprocedure.

The primary safety endpoint was defined as the number of patients with a composite of freedom from major adverse limb event (MALE) and perioperative death at 30 days after the index procedure. The data showed no perioperative deaths or major amputations at 30 days. One major reintervention was reported in the 35 trial patients. In the per-protocol population, there was an 8% rate of MALE (two clinically driven target limb revascularizations) at 6 months, with no additional adverse events reported for per-protocol patients in the 12-month data.

The target lesion primary patency rate was 80% at 12 months in the per-protocol population. Target lesion primary patency was 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%.

“Patient-reported outcome measures have continued to improve from baseline throughout the first 12 months for our modified intent-to-treat subject population,” commented Prof. Varcoe in the Surmodics press release. “The SWING trial demonstrates that the Sundance sirolimus DCB has tremendous promise and warrants evaluation in a large-scale pivotal trial.”

Professor Andrew Holden, MD, Colead Investigator of the trial, added, “Improvement in Rutherford clinical classification increased between the 1-month, 6-month, and 12-month endpoints, with significant clinical improvement demonstrated in 76% of per-protocol subjects at 12 months.”

The Sundance sirolimus DCB is not available for sale anywhere in the world and currently is for investigational use only, advised Surmodics.