MedAlliance has enrolled the first US patient in the SELUTION4SFA study of SELUTION SLR for the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
Led by Dr. Arthur Lee at the Cardiac & Vascular Institute in Florida, the study will evaluate SELUTION SLR, a limus release drug-eluting balloon (DEB).
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The study will enroll 300 patients to demonstrate the superiority of SELUTION SLR over balloon angioplasty (POBA).
It is being conducted in around 30 centres in the US with an additional 10 centres across the globe.
Primary patency of the target lesion at 12 months is the primary efficacy endpoint of the study and the primary safety endpoint is freedom from death at 30 days.
The study is expected to be completed by the end of this year.
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By GlobalDataMedAlliance chairman and CEO Jeffrey Jump said: “We are pleased to be enrolling our third IDE study in US patients, and look forward to the results of these three studies as well as future IDE studies to come.”
SELUTION SLR is available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries.
In May 2020, SELUTION SLR received CE Mark approval to treat coronary artery disease.
