Country for PR: United Kingdom
Contributor: PR Newswire Europe
Wednesday, November 25 2020 - 01:30
MedAlliance announces successful completion of enrolment in ISABELLA clinical trial for the treatment of failing AV fistulas in hemodialysis patients
NYON, Switzerland, Nov. 25, 2020/PRNewswire-AsiaNet/ --

    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. 

    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 CATâ„¢ (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
    +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:


    Source: MedAlliance