Surmodics’s drug-coated balloon met main security and efficacy endpoints in a first-in-human research for the therapy of occlusive illness of infrapopliteal arteries.
US-based Surmodics introduced the 24-month information on the VEITH Symposium held in New York from 14 to 18 November, in keeping with a 16 November press release.
The research, known as SWING, concerned 35 topics with stenotic or occluded lesions of the infrapopliteal arteries – the vessels beneath the knee – being handled with Surmodics’s Sundance sirolimus drug-coated balloon.
Outcomes from the possible, multi-centre, single-arm, feasibility research demonstrated no perioperative deaths or main amputations at 30 days, assembly the first security endpoint. Surmodics reported that one main re-intervention was wanted, and an 8.3% price of main adversarial occasions at six months. Within the one-year and two-year information, no extra adversarial occasions had been reported.
The first efficacy endpoint, as measured by the speed of lumen loss at six months, was additionally met. Surmodics reported late lumen lack of 1mm throughout 35 lesions. The corporate mentioned this means sustained luminal acquire post-procedure. Surmodics moreover reported a 71.4% goal lesion main patency price.
The remedy works by utilizing a balloon to boost and maximise the switch of sirolimus – an anti-restenotic drug.
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The research’s co-lead investigator Andrew Holden mentioned: “The 2-year security and efficiency outcomes of the SWING trial proceed to indicate promise for the Sundance Sirolimus drug-coated balloon in treating below-the-knee illness in a difficult power limb-threatening ischemia affected person inhabitants the place choices are at present restricted.”
Sirolimus-coated balloons are gaining reputation in investigational trials for the therapy of cardiovascular indications. In August 2023, MedAlliance completed enrolment for a trial investigating its balloon within the therapy of arteriovenous fistulas. MedAlliance was acquired by Cordis for $1.1bn final month.