The first two patients have been enrolled in the PRISTINE registry with MedAlliance’s SELUTION SLR™ 018 Drug Eluting Balloon (DEB) for the treatment of patients with Below The Knee disease (Chronic Limb Threatening Ischemia).
SELUTION SLR™ 018 is the first DEB accepted by the FDA for its “Breakthrough Program”. SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).
SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been proven 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.
The PRISTINE registry is a follow up to the encouraging results seen in the PRESTIGE clinical trial (Below The Knee, Chronic Limb Threatening Ischemia) at 6 months.
PRISTINE is a Prospective Registry to Investigate the Safety and efficacy of Treatment with SELUTION SLR™ Sirolimus Drug Coated Balloon in TASC C and D athero-occlusive Infra-iNguinal disease in patients with chronic limb threatening ischemia from SingaporE.
The objective of the registry is to evaluate over 12 months safety and performance outcomes in 75 patients, with SELUTION SLR DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb threatening ischemia (CLTI) at Singapore General Hospital.
The clinical primary safety endpoint of the registry is freedom from Major Adverse Events through 30 days and the performance primary endpoint is freedom from cd-TLR within 6 months. The secondary endpoints are primary patency at 6 & 12 months follow-up, freedom from cd-TLR at 12 months, clinical success at follow-up in Rutherford score by one class or more, wound healing at 6 months and freedom from major target limb amputation within 6 and 12 months post index procedure.
“We are excited about the commencement of this large single-centre prospective study focusing on patients with chronic limb threatening ischemia receiving the novel sirolimus drug eluting balloon (Selution SLR DEB) from MedAlliance”, said Associate Professor Chong Tze Tec, Head & Senior Consultant, Department of Vascular Surgery, Singapore General Hospital. “We believe this registry will give us detailed insight into the efficacy & safety of this new balloon technology which will benefit this challenging group of patients.”
“This is a particularly important study for MedAlliance”, explained Chairman and CEO Jeffrey B. Jump. Our breakthrough technology has shown to be effective & safe in below the knee diseases in highly complex patients in Singapore as seen in the PRESTIGE trial. We are expecting similar observations in the PRISTINE registry. SELUTION SLR is designed to deliver the same safety and performance as best-in-class DES technology with the added benefit of leaving nothing behind.”
Source: MedAlliance SA