November 25, 2020
ISABELLA Trial with SELUTION SLR 018 DEB for the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis patient enrollment is completed reports MedAlliance. 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).
ISABELLA Trial (Intervention with SELUTION SLR Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas) s 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.
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.
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 the trial, 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 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 an 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 Chairman and CEO Jeffrey B. Jump.
In February 2020 the company received CE Mark approval for SELUTION SLR in the treatment of peripheral artery disease. The company recently announced the completion of its below-the-knee (BTK) First-in-Human study in Singapore. The SAVE Study in Arteriovenous 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. The US FDA IDE ISR study began enrolment in the summer of 2020.
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 adhere to the vessel lumen when delivered via an angioplasty balloon.