MedAlliance has announced that it now has the CE mark for the Selution SLR—a sirolimus drug-eluting balloon for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm. According to a press release, this award was supported by two-year results from the SELUTION SLR first-in-human study, which involved 50 patients enrolled across four German centres.
The press release states that 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 rate and a 0.19 late lumen loss rate. Furthermore, two-year clinical results confirmed no deaths or amputations. Patients demonstrated clinical improvement as measured by Rutherford Classification, ankle-brachial index and walking distance at six months and one year, which was maintained out to two years. This evidence, the press release notes, 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 freedom from target lesion revascularisation through to two years in 87.5% of patients, with no primary target lesion revascularisation event observed after 11 months. 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.
Selution SLR’s technology involves microreservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These micro-reservoirs are designed to provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
Jeffrey B Jump, MedAlliance chairman and CEO, says: “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. 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.”