Differentiated Capabilities of Surmodics’ Crystalline Drug Release Platform for Sirolimus-Coated Balloons Presented at ISET Conference
Surmodics, Inc. (NASDAQ:SRDX) announced the successful 12-month results of its SWING trial for the Sundance™ Sirolimus-Coated Balloon (SCB) at the ISET symposium in Miami. The trial, which included 35 patients, reported no perioperative deaths and only one major re-intervention. Notably, the primary patency rate remained at 80% after a year, demonstrating the efficacy of the company's Crystalline Drug Release (CDR) platform. CDR enhances sirolimus delivery and retention in tissues compared to traditional methods. The SWING trial marks a significant step in advancing medical technology for peripheral artery disease treatment.
- 80% primary patency rate at 12 months in the trial's per protocol population.
- No perioperative deaths or major amputations among the trial subjects.
- Only one major re-intervention reported in 12 months.
- The CDR platform shows enhanced drug transfer and retention compared to competitors.
- None.
Surmodics’ proprietary Crystalline Drug Release (CDR) platform enhances sirolimus stability, transfer, and retention in tissue CDR discussed in connection with 12-month data from Surmodics’ SWING trial of the Sundance™ Sirolimus-Coated Balloon
At ISET, SWING co-lead investigator Professor
“The technical benefits of CDR are clearly evident via in vivo animal models, which show that the Sundance SCB provides enhanced drug transfer and enables longer drug retention in tissue at therapeutic levels compared with competitor SCBs,” said
As noted by
Rather than using encapsulation, the Sundance™ SCB delivers drug to target tissue via a coating of stable crystalline sirolimus with a proprietary excipient on the balloon surface, a method the Company describes as Crystalline Drug Release, or CDR. When inflated, the Sundance™ SCB transfers this crystalline drug form to the vessel wall, whereupon the crystalized drug itself serves as the drug depot in a process that eliminates the need for a polymer depot. CDR is new in the SCB space.
About the SWING Trial
The SWING Trial is a 35-subject prospective, multi-center, single-arm, feasibility study to evaluate the safety and performance of the Sundance SCB 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 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 of Rutherford Clinical Classification and/or increase in size of pre-existing wounds (or occurrence of new wounds), and lesion restenosis >
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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