October 12, 2020
PRISTINE Study with SELUTION SLR Sirolimus Drug Eluting Balloon Update: MedAlliance has announced the enrolment of the first two patients in the PRISTINE registry with SELUTION SLR™ 018 DEB for the treatment of patients with Below The Knee disease (Chronic Limb Threatening Ischemia). This is the first DEB (drug-eluting balloon) 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).
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.”
“We are delighted to report enrolment of the first two patients in the exciting PRISTINE Registry”, added Associate Professor Tjun Tang, lead Investigator and a senior consultant in the Department of Vascular Surgery, Singapore General Hospital, Singapore. “CLTI represents the worse part of the spectrum of peripheral artery disease and patients are at an increased risk of limb loss and mortality. The incidence is likely to increase in Singapore because of the rising trend in diabetes and end stage renal disease in the country and these patients are a challenging and frail population of patients. We currently do far too many major lower limb amputations: in fact the rate in Singapore is two to three times higher than in western countries. We seriously need to address this issue. One of the cornerstones of treatment is to re-establish pulsatile blood flow to the foot to promote wound healing and although percutaneous lower limb angioplasty has become the favoured option of revascularization, its Achilles heel is vessel recoil and restenosis from neointimal hyperplasia”.
The SELUTION Sustained Limus Release DEB offers an effective treatment for NIH in CLTI and has shown good target lesion patency, low target lesion revascularisation & relatively high amputation free survival as evidenced from the 6 months results of the completed PRESTIGE Trial, which was an exploratory study investigating the efficacy and safety of the same balloon in below the knee atherosclerotic lesions in the setting of tissue loss at the same hospital.
“SGH performs over 900 lower limb salvage revascularisation procedures per year and has established multi-disciplinary wound management protocols and we are highly encouraged by the pilot data we have found using this technology so far and PRISTINE will offer further insight, leveraging on our experience with PRESTIGE, whether this sirolimus coated balloon will become an established device in our angioplasty armamentarium in the future”, concluded Associate Professor Tang.
“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.”
In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in the treatment of peripheral artery disease. The company recently announced completion of its below-the-knee (BTK) First-in-Human study in Singapore. The SAVE Study in Arterial Venus Fistula (AVF) enrolled its first patient in April. The STEP Pedal Arch study is to commence enrolment this quarter. A 500-patient post marketing clinical study will follow as well as the US IDE ISR study which has begun enrolment.
MedAlliance is the first DEB company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a coronary DEB. SELUTION SLR has now achieved this status for a range of indications: the treatment of AV-Fistula; coronary in-stent restenosis and peripheral below-the-knee lesions.
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.