Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention Symposium (AMP) held Oct. 9–11 in Lugano, Switzerland.
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 study’s primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major reintervention was reported among the 35 trial subjects, a Surmodics press release reports. Data for the primary efficacy endpoint show a late lumen loss (LLL) of 1mm (±0.79mm) across 35 lesions at six months, indicating that the large luminal gain achieved immediately after the procedure was sustained six months post-treatment.
“At six 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,” said SWING trial co-lead investigator Ramon Varcoe, MD, a vascular surgeon at the Prince of Wales Hospital and associate professor of vascular surgery at the University of New South Wales in Sydney, Australia.
The SWING trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter (RVD) of 2mm to 4mm, and a total lesion length of ≤230mm for treatment with the Sundance sirolimus DCB at eight sites in Australia, New Zealand, and multiple locations in Europe. They will be followed for 36 months following the index procedure.
“The novel coating on the Sundance sirolimus DCB was evaluated in a challenging, predominantly CLTI [chronic limb-threatening ischemia] population with a high proportion of diabetes and moderate-severe calcification,” said trial co-lead investigator Andrew Holden, MD, director of interventional radiology at the University of Auckland in Auckland, New Zealand. “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.”
The Sundance sirolimus DCB utilizes a “next-generation” coating technology consisting of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, which, according to Surmodics, enhances sirolimus delivery and sustains therapeutic levels in the artery.
In a press release, Surmodics notes that sirolimus is a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. “The delivery of sirolimus to the vessel wall during mechanical dilatation provides an ancillary action of inhibiting the proliferation of cells, with the intended purpose of reducing restenosis,” the company adds. Surmodics advises that the Sundance sirolimus DCB is not available for sale anywhere in the world, and currently is for investigational use only.