PR86844

NYON, Switzerland, Nov. 25, 2020/PRNewswire=KYODO JBN/ --

    MedAlliance has announced completion of patient enrolment in the ISABELLA

Clinical Trial with SELUTION SLR(TM) 018 DEB (drug-eluting balloon) for the

treatment of dysfunctional AV fistulas in end-stage renal failure patients

undergoing hemodialysis. 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 (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.

    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 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 Chairman and CEO Jeffrey B. Jump.

    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 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.

    Media Contact:

    Richard Kenyon

    rkenyon@medalliance.com

    +44 7831 569940

    About MedAlliance

    Founded in 2008, MedAlliance is a privately-owned medical technology

company. It is headquartered in Switzerland, with facilities in Irvine,

California; Glasgow, UK; and Singapore. MedAlliance specializes in the

development of ground-breaking technology and commercialization of advanced

drug device combination products for the treatment of coronary and peripheral

artery disease. For further information visit: www.medalliance.com

    Photo: https://mma.prnewswire.com/media/1341689/SELUTION_SLR.jpg  

    Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg

    Source: MedAlliance