6-Month Data from the Surmodics SWING BTK First-in-Human Trial Presented at AMP Europe
Surmodics, Inc. (NASDAQ:SRDX) announced promising 6-month results from the SWING study of its Sundance™ Sirolimus drug-coated balloon (DCB) at the Amputation Prevention Symposium in Lugano, Switzerland. The study reported an 88.5% primary patency rate and a Late Lumen Loss (LLL) of 1.0 mm across 35 lesions, indicating sustained efficacy. No major amputations or perioperative deaths were observed, and only one major re-intervention was needed among participants. The Sundance DCB employs innovative coating technology to enhance sirolimus delivery, aiming to reduce restenosis.
- 88.5% primary patency rate for Sundance Sirolimus DCB.
- Only one major re-intervention among 35 subjects.
- No major amputations or perioperative deaths reported.
- Sustained efficacy with a Late Lumen Loss of 1.0 mm at 6 months.
- None.
Sundance™ Sirolimus DCB demonstrates lowest binary restenosis at 6 months compared to relevant BTK clinical trials
Excellent safety profile observed with no major amputations and low rates of MAE
The SWING study is a 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 study’s 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. Data for the primary efficacy endpoint show a Late Lumen Loss (LLL) 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 six months post-treatment.
“At 6 months we observed a consistent improvement in Rutherford category and functional measures, as well as an excellent primary patency of
The Swing Trial enrolled subjects with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter (RVD) 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 novel coating on the Sundance Sirolimus DCB was evaluated in a challenging, predominantly CLI population with a high proportion of diabetes and moderate-severe calcification,” said trial co-lead investigator Professor
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 beliefs and expectations regarding the Sundance™ Sirolimus DCB, 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 proprietary 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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