AsiaNet 88043

NYON, Switzerland, Feb. 11, 2021 /PRNewswire=KYODO JBN/ --

     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

    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: https://medalliance.com/

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

    Photo: https://mma.prnewswire.com/media/1436580/SELUTION_SLR.jpg

    Source: MedAlliance