Surmodics Announces 12-Month Data from the SWING Trial Presented at VEITHsymposium
Surmodics, Inc. (NASDAQ:SRDX) announced promising results from the SWING Trial of its Sundance™ Sirolimus drug-coated balloon (DCB), a treatment for occlusive infra-popliteal disease. Presented at the VEITHsymposium in New York, 12-month data showed an 80% primary patency rate in the per protocol population. The trial, which followed 35 subjects, reported no perioperative deaths and only one major re-intervention. The efficacy endpoint of late lumen loss was measured at 1.0 mm at six months, indicating sustained results. The DCB is currently for investigational use only and not yet available for sale.
- 80% primary patency rate at 12 months in the per protocol population.
- No perioperative deaths and only one major re-intervention in the SWING Trial.
- Efficacy demonstrated with late lumen loss of 1.0 mm at 6 months indicating sustained results.
- None.
Sundance™ Sirolimus Drug-Coated Balloon exhibits excellent safety profile
Primary patency maintained at 12 months in
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 infra-popliteal 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
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
Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration or Rutherford Clinical Classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >
“Patient-reported outcome measures have continued to improve from baseline throughout the first 12 months for our modified intent to treat subject population,” said SWING Trial co-lead investigator Professor
“Improvement in Rutherford Clinical Classification increased between the 1-month, 6-month, and 12-month endpoints, with significant clinical improvement demonstrated in
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 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 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.
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Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about the promise of the Sundance™ Sirolimus Drug-Coated Balloon and that it warrants evaluation in a large-scale pivotal trial, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including (1) our ability to successfully develop, obtain regulatory approval for, and commercialize our drug-coated balloon products; and (2) the factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended
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