Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today 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 VEITHsymposium 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 the Sundance 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 DCB 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.
“The two-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 CLTI patient population where options are currently limited,” said Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service (Auckland City Hospital, Auckland, New Zealand), co-lead investigator.
“We need to continue to strive for better treatments for treating infrapopliteal disease,” added Professor Varcoe. “These results are promising and will inform future trials, which we hope will continue to advance improved treatments for our patients.”
About the Sundance™ Sirolimus Drug Coated Balloon
The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline Sirolimus and a proprietary excipient designed to maximize drug transfer, enhancing Sirolimus delivery and sustaining therapeutic levels in the artery. Sirolimus, 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 balloon dilatation provides an ancillary action of inhibiting the proliferation of cells, with the intended purpose of reducing restenosis. The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.