MedAlliance has announced the award of its first CE mark approval: for SELUTION SLR, a novel sirolimus drug-eluting balloon (DEB), for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm.
This award was supported by two-year results from the SELUTION SLR first-in-human study, involving 50 patients enrolled across four German centres. SELUTION SLR is the first and only sirolimus drug-eluting balloon to have six months’ clinical follow-up demonstrating a 2.3% target lesion revascularisation (TLR) and a 0.19 late lumen loss (LLL). Two-year clinical results confirmed no deaths or amputations. Patients demonstrated clinical improvement as measured by Rutherford classification, ABI and walking distance at six months and one year, which was maintained out to two years. This evidence demonstrates that a sustained limus release drug-eluting balloon is both safe and effective for the treatment of femoropopliteal lesions over a prolonged period.
The study involved 50 patients enrolled across four German centres and achieved excellent freedom from TLR through to two years in 87.5% of subjects, with no primary TLR event observed after month 11. These figures are low compared to reported historical first-in-human studies. There were no incidences of death or the need for minor and/or major amputations over this period. These Patients demonstrated clinical improvement as measured by Rutherford classification, ABI and walking distance at six months and one year, which was maintained out to two years.
“We are very excited to have been awarded our first CE mark, which is testament to the documented efficacy and safety of our novel sustained limus release eluting balloon”, said MedAlliance Chairman and CEO Jeffrey B Jump. “We now anticipate that patients in all markets where the CE mark is recognised will be able to benefit from this breakthrough in drug-eluting technology.”
MedAlliance has recently announced completion of its below-the-knee (BTK) first-in-human study in Singapore. Studies in arterial venous fistula (AVF) and pedal arch are to start enrolling soon. A 500 patient post marketing clinical study will follow shortly.
