MedAlliance says it has completed patient enrolment in the ISABELLA Clinical Trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis.
Hemodialysis access failures contribute to significant morbidity and costs to patients and the healthcare system worldwide. Significant resources and a substantial proportion of vascular surgeons’, nephrologists’ and interventional radiologists’ work goes on maintaining access patency. It is beneficial to have any strategy that reduces access failure or prolongs access lifespan. There has been a paradigm shift in management of hemodialysis access failures towards restenosis with the use of DEB – similar to how DEB has influenced the management of CAD in-stent restenosis and PAD.
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 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.
ISABELLA (Intervention with SELUTION SLR Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas) is a prospective single-center, multi-investigator, non-blinded, single arm trial investigating the safety and feasibility of SELUTION SLR 018 DEB for the treatment of failing AV fistulas in 40 hemodialysis patients.
The objective of this study is to determine the safety and efficacy of SELUTION SLR 018 DEB in the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis. The anticipated clinical benefit is to improve the target lesion primary patency and reduce the number of re-interventions in stenotic AV fistulas of hemodialysis patients and hence morbidity in this frail patient population compared to conventional balloon angioplasty (CBA). The efficacy endpoint of interest is six-month target lesion primary patency and the safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggest the involvement of the AVF circuit. The study has recently completed its 40-patient recruitment and will follow them up for a period of two years at Singapore General Hospital (SGH), which performs over 3000 access salvage procedures annually.
“We are very excited at SGH and eagerly await the results from ISABELLA, which will be the first study to report clinical safety and efficacy data of sirolimus-eluting balloon (SEB) angioplasty using the SELUTION SLR DEB catheter combined with high pressure CBA vessel preparation, for dysfunctional AVF circuits in Asian hemodialysis patients”, said lead principal investigator Associate Professor Tjun Tang, Senior Consultant Vascular and Endovascular Surgeon at SGH.
“SEBs are a natural evolution of the current gold standard treatment option of CBA for salvaging failing and stenotic AVF circuits. Paclitaxel drug-coated balloons have been used with limited success and the data are far from conclusive. The SELUTION SLR DEB provides therapeutic concentrations of drug within the vessel wall for at least 90 days post-angioplasty, which is a major advantage over other drug-coated balloons in dealing with the extended nature of the NIH process. Our plan is to follow-up patients to two years to define the effectiveness of the studied therapy in the medium term.”
“We are pleased to announce that the ISABELLA trial has successfully completed recruitment of the intended 40 subjects”, added Associate Professor Chong Tze Tec, Head & Senior Consultant, Department of Vascular Surgery, SGH. This study will seek to determine the safety and efficacy of the MedAlliance SELUTION SLR DEB in the treatment of failing AV fistula due to conduit stenosis in patients undergoing renal dialysis. In light of recent safety concerns with paclitaxel-based products, this study should give vital information on an alternative drug-eluting solution.
“We are delighted that this study completed enrolment so quickly as we hope to demonstrate increased benefit for hemodialysis patients. We hope the SELUTION SLR technology will lead to extending the length and quality of life for many dialysis patients around the world”, said MedAlliance Chairman and CEO Jeffrey B. Jump.