MedAlliance announced on Monday that it received CE-mark approval for Selution SLR, a sirolimus drug-eluting balloon, for the treatment of peripheral arterial disease. CEO Jeffrey Jump remarked that "we are very excited to have been awarded our first CE mark."
The approval, which applies to sizes from 2.0 x 20mm to 7.0 x 150mm, was supported by two-year results from the 50-patient SELUTION SLR first-in-human study. The device "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," MedAlliance noted.
Results showed that 87.5% of participants achieved freedom from TLR through to two years, with no primary TLR event observed after month 11. According to MedAlliance, "these figures are low compared to reported historical first-in-human studies." In addition, patients achieved clinical improvement as measured by Rutherford classification, ankle-brachial index (ABI) and walking distance at six months and one year, which was maintained out to two years. There were also no incidences of death or the need for amputations, with MedAlliance suggesting that "a sustained sirolimus-release drug-eluting balloon is both safe and effective for the treatment of femoropopliteal lesions over a prolonged period."
The device features "micro-reservoirs," made from biodegradable polymer intermixed with sirolimus, which provide controlled and sustained release of the drug. Further, the company noted that its cell-adherent technology enables the micro-reservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
Last year, the FDA highlighted a "late mortality signal" that had been seen in patients treated for peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents, with the agency later advising that long-term safety and effectiveness data should continue to be collected on such devices. Study findings published in the European Heart Journal last October concluded that paclitaxel-coated devices are in fact safe for endovascular therapy of the lower limbs.
Meanwhile, MedAlliance recently announced that enrolment has been completed in the PRESTIGE below-the-knee clinical trial, evaluating six-month safety and performance outcomes of the Selution SLR for the treatment of long tibial occlusive lesions in patients with critical limb ischaemia. It added that trials in arteriovenous fistula and pedal arch are set to start enrolling soon, while a 500-patient post-marketing study will follow shortly.
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