Surmodics’ Sundance DCB Evaluated in SWING BTK First-in-Human Trial

October 11, 2022—Surmodics, Inc. announced that 6-month data from its SWING first-in-human study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at AMP Europe, the European program of the Amputation Prevention Symposium held October 9-11 in Lugano, Switzerland.

According to the company, the SWING study is a prospective, multicenter, single-arm, feasibility study to evaluate the safety and performance of the Sundance sirolimus DCB when used to treat occlusive disease of the infrapopliteal arteries.

The SWING trial enrolled 35 patients at eight sites in Australia, New Zealand, and multiple locations in Europe for treatment with the Sundance DCB. The patients had 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. The patients will be followed for 36 months after the index procedure.

Surmodics reported that the study’s primary safety endpoint data showed no perioperative deaths or major amputations at 30 days with one major re-intervention in the 35 trial patients. Data for the primary efficacy endpoint show a 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 6 months post-treatment.

Professor Ramon Varcoe, MBBS, and Professor Andrew Holden, MD, are colead investigators of the SWING trial.

“At 6 months, we observed a consistent improvement in Rutherford category and functional measures, as well as an excellent primary patency of 88.5%, which compares favorably to other DCBs used in the infrapopliteal circulation,” commented Prof. Varcoe in Surmodics’ press release.

Prof. Holden added, “The novel coating on the Sundance sirolimus DCB was evaluated in a challenging, predominantly critical limb ischemia population with a high proportion of diabetes and moderate-severe calcification. This first-in-human study demonstrates that the Sundance sirolimus DCB could be a safe and promising treatment for occlusive disease of the infrapopliteal arteries.”

Surmodics stated that the Sundance DCB utilizes a next-generation coating technology consisting of microcrystalline sirolimus and the company’s excipient to maximize drug transfer, enhancing sirolimus delivery and sustaining therapeutic levels in the artery. The Sundance sirolimus DCB currently is for investigational use only and is not available for sale anywhere in the world.