MedAlliance, a medical technology company, has reportedly announced the enrollment of the 1st two patients in the Prospective Registry, PRISTINE, with SELUTION SLR™ 018 DEB. The PRISTINE trial will be conducted among patients with BTK (below-the-knee) disease, which is a chronic limb-threatening ischemia.

SELUTION SLR™ 018 DEB is the 1st drug-eluting balloon accepted by the U.S. FDA for the breakthrough program. It is a sirolimus-eluting balloon that offers a controlled and sustained release of drugs. The PRISTINE registry is a further examination, which is encouraged by the results from the PRESTIGE clinical trial.

PRISTINE will investigate the efficacy & safety of SELUTION SLR™ Sirolimus DCB (drug-coated balloon) for the treatment of the TASC C/D athero-occlusive infrainguinal disease in Singapore. The main objective of the registry is to examine the safety & performance outcomes among 75 patients for over 12 months.

The registry’s clinical primary endpoint is to evaluate whether the patients develop major adverse events in a period of 30 days, while the performance primary endpoint is to achieve freedom from cd-TLR in 6 months. On the other hand, the secondary endpoints include primary patency at 6 and 12 months follow-up, clinical success at follow-up in Rutherford by 1 or more class, freedom from cd-TLR in 12 months, wound healing in 6 months, as well as freedom from the major target limb amputation in 6-12 months after index exposure.

SELUTION SLR DEB provides an effective treatment for NIH. It has shown low target lesion revascularization, good target lesion patency, and relatively high amputation-free survival, which is evident from the 6-month results of the PRESTIGE trial.

MedAlliance received the CE marking for its SELUTION SLR in February 2020, which can be used in the peripheral artery disease treatment. It is the 1st global DEB company to have received the FDA breakthrough device designation status. Currently, SELUTION SLR can be adopted in a range of indications such as the treatment of AV-Fistula. This technology involves MicroReservoirs, developed from a biodegradable polymer that is intermixed with anti-restenotic drug sirolimus.

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https://www.prnewswire.com/in/news-releases/enrolment-of-first-two-patients-in-pristine-study-with-selution-slr-tm-sirolimus-drug-eluting-balloon-869624278.html