Surmodics’ Sundance Sirolimus-Coated Balloon With Crystalline Drug Release Platform Evaluated in SWING Trial

January 19, 2023—Surmodics, Inc. announced that the differentiated capabilities of its crystalline drug release (CDR) platform for sirolimus-coated balloons (SCBs) were discussed by Professor Ramon Varcoe, MBBS, in his presentation of 12-month data that reinforced key findings from SWING, the first-in-human trial of the company’s Sundance SCB.

According to Surmodics, the data showed no perioperative deaths or major amputations at 30 days. One major reintervention was reported among the trial patients. Use of the Sundance SCB was associated with primary patency maintained at 12 months in 80% of the per-protocol analysis population.

Prof. Varcoe, Colead Investigator of SWING, delivered the findings at ISET, the 35th annual International Symposium on Endovascular Therapy held January 16-19 in Miami Beach, Florida.

As summarized in the press release, rather than using the traditional mode of encapsulation for drug delivery to achieve sustained therapeutic levels of the drug in arterial tissue, the Sundance SCB delivers drug to target tissue via a coating of stable crystalline sirolimus with the company’s excipient on the balloon surface—which the company calls “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.

In the company’s press release, Prof. Varcoe commented, “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. The positive 12-month data from SWING suggest that the Sundance SCB’s CDR platform holds significant promise for treating real-world PAD patients.”

The SWING trial is a prospective, multicenter, single-arm, feasibility study to evaluate the safety and performance of the Sundance SCB when used to treat occlusive disease of the infrapopliteal arteries. The trial enrolled 35 patients with stenotic or occluded lesions of the infrapopliteal arteries, a reference vessel diameter of 2 to 4 mm, and a total lesion length of ≤ 230 mm for treatment with the Sundance SCB at eight sites in Australia, New Zealand, and/or Europe. The patients will be followed for 36 months post–index procedure.

The primary safety endpoint was defined as the number of patients with a composite of freedom from a major adverse limb event and perioperative death at 30 days after the index procedure. Primary safety endpoint data showed no perioperative deaths or major amputations at 30 days, and one major reintervention was reported among the 35 trial patients. The per-protocol population reported an 8% rate of major adverse events (two clinically driven target limb revascularizations) at 6 months, with no additional adverse events reported for per-protocol patients in the 12-month data.

The primary efficacy endpoint was late lumen loss at 6 months, as assessed by quantitative vascular angiography. Primary efficacy data showed late lumen loss of 1 mm (± 0.79 mm) across 35 lesions at 6 months, indicating that the large luminal gain achieved immediately after the procedure was sustained postprocedure.

Both primary endpoints of the SWING trial were achieved.

Target lesion primary patency rate, defined as freedom from target vessel occlusion or target lesion revascularization associated with deterioration of Rutherford classification and/or increase in size of preexisting wounds (or occurrence of new wounds), and lesion restenosis > 50%, was 80% at 12 months in the per-protocol population.

Prof. Varcoe’s presentation of SWING is available on the company’s website here. Prof. Varcoe previously presented the SWING 12-month findings at the 49th annual VEITHsymposium held November 15-19 in New York, New York.

The Sundance SBC is not available for sale anywhere in the world and currently is for investigational use only, advised the company.