SurModics’s drug-coated balloon met primary safety and efficacy endpoints in a first-in-human study for the treatment of occlusive disease of infrapopliteal arteries.
US-based Surmodics announced the 24-month data at the VEITH Symposium held in New York from 14 to 18 November, according to a 16 November press release.
The study, called SWING, involved 35 subjects with stenotic or occluded lesions of the infrapopliteal arteries – the vessels below the knee – being treated with Surmodics’s Sundance sirolimus drug-coated balloon.
Results from the prospective, multi-centre, single-arm, feasibility study demonstrated no perioperative deaths or major amputations at 30 days, meeting the primary safety endpoint. Surmodics reported that one major re-intervention was needed, and an 8.3% rate of major adverse events at six months. In the one-year and two-year data, no additional adverse events were reported.
The primary efficacy endpoint, as measured by the rate of lumen loss at six months, was also met. Surmodics reported late lumen loss of 1mm across 35 lesions. The company said this indicates sustained luminal gain post-procedure. Surmodics additionally reported a 71.4% target lesion primary patency rate.
The therapy works by using a balloon to enhance and maximise the transfer of sirolimus – an anti-restenotic drug.
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The study’s co-lead investigator Andrew Holden said: “The two-year safety and performance results of the SWING trial continue to show promise for the Sundance Sirolimus drug-coated balloon in treating below-the-knee disease in a challenging chronic limb-threatening ischemia patient population where options are currently limited.”
Sirolimus-coated balloons are gaining popularity in investigational trials for the treatment of cardiovascular indications. In August 2023, MedAlliance completed enrolment for a trial investigating its balloon in the treatment of arteriovenous fistulas. MedAlliance was acquired by Cordis for $1.1bn last month.