Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, February 11 2021 - 08:00
First Patient Enrolled in SELUTION SLR(TM) SUCCESS PTA Study
NYON, Switzerland, Feb. 11, 2021 /PRNewswire-AsiaNet/ --

    MedAlliance has announced enrolment of the first patient in SUCCESS PTA, 
its large post-market study with the drug-eluting balloon SELUTION SLR(TM) for 
the treatment of patients with peripheral artery disease (PAD). SELUTION SLR is 
a novel sirolimus-eluting balloon that provides a controlled sustained release 
of drug, similar to that of a drug-eluting stent (DES).

    The objective of the study is to collect 'real-world' safety, efficacy, 
health economics and patient reported quality-of-life data in over 700 patients 
with PAD treated with SELUTION SLR. It is a single arm all-comers study 
including all lower limb indications (SFA; BTK; Foot) and will cover at least 
50 sites in Europe, Asia and South America. Patients will be followed-up at 30 
days; six months; then every year out to five years. 

    The primary endpoint of the study is Clinically Driven Target Lesion 
Revascularization (CD-TLR) at 12 months. Secondary endpoints include device 
success and procedure success; Major Adverse Limb Events (MALE); and Target 
Limb Revascularization (TLR).  

    "Given the impressive performance of this novel device in earlier studies, 
we are very excited to see how SELUTION SLR will perform in a larger group of 
patients in a real world setting," commented the study's Principal Investigator 
Michael Lichtenberg, Arnsberg, Germany. 

    "SUCCESS PTA is part of the SUCCESS post-market study family, designed to 
show patient benefits in real world use of our technology," added Chairman and 
CEO Jeffrey B. Jump. "This is the largest study we have ever undertaken with 
SELUTION SLR, involving the most diverse group of patients. We are confident 
that the results will confirm the safety, efficacy and cost-effectiveness of 
our sirolimus-eluting balloon."

    In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in 
the treatment of PAD. This award was supported by results from the 
First-in-Human study. 

    Data from the SUCCESS PTA study will be part of the clinical evidence 
supporting CE Mark renewal in 2023/2024 under the new European Medical Device 
Directive (MDR). 

    SELUTION SLR has also received US Food and Drug Administration (FDA) 
Breakthrough Device Designation Status for peripheral below-the-knee lesions as 
well as for the treatment of AV-Fistula.

    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(TM) (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