PR84736

NYON, Switzerland, July 11, 2020 /PRNewswire=KYODO JBN/ --

    MedAlliance has announced enrollment of the first patient in its study of

SELUTION SLR(TM) 014 DEB (http://medalliance.com/product/ )for the treatment of

In-Stent Restenosis (ISR). This is the first DEB accepted by the FDA for its

'Breakthrough Program'. The 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).

    The objectives of this prospective, randomized, single-blind multicenter

study are to demonstrate the safety and efficacy of SELUTION SLR in treatment

of ISR with either drug-eluting or bare metal stents (BMS). The study will

support submission for FDA approval.

    "This first patient was treated with the investigational device after

suffering a DES ISR. We are delighted to be able to offer our patients this

promising new technology," commented Professor Pascal Vranckx, Hartcentrum

Hasselt, Belgium. "We are excited to participate in a study that validates this

novel technology for ISR treatment. SELUTION SLR may provide an additional

treatment option for these patients. We very much look forward to the results

of this study."

    Up to 418 subjects will be recruited into the study at approximately 60

sites across both the US and Europe. Subjects need to have a BMS or DES ISR

involving a native coronary artery with a reference vessel diameter (RVD) of

2.00 – 4.50 mm to qualify for inclusion. Subjects will be randomized to receive

either SELUTION SLR or Standard of Care (SOC) – a control group with a current

DES or a non-drug eluting balloon angioplasty.

    The primary endpoint for effectiveness of the study is Target Lesion

Failure (TLF): defined as all cardiac death; target vessel myocardial

infarction; or clinically driven Target Lesion Revascularization (TLR) at 12 months.

    Subjects will be followed up at one month, six months, 12 months and then

annually through five years.

    "This is a particularly important study for MedAlliance," explained

Chairman and CEO Jeffrey B. Jump. "No coronary drug-eluting balloon has yet

been approved in the US, where ISR currently represents 11% of all stent

implantations. We are excited to introduce this breakthrough technology to help

patients around the world." The Principal Investigator of this study is Donald

Cutlip, Professor of Medicine at Harvard Medical School and Chief Medical

Officer at the Baim Institute for Clinical Research. Professor Cutlip helped

design the study in consultation with the Institute.

    SELUTION SLR's technology involves unique MicroReservoirs made from

biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These

MicroReservoirs provide controlled and Sustained Limus Release (SLR) of the

drug. Extended release of sirolimus from stents has been demonstrated 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 adhered to the vessel lumen when delivered via an

angioplasty balloon.

    SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral

artery disease in February 2020 and for the treatment of coronary arterial

disease in May 2020. It is now is available in Europe and all other countries

where the CE Mark is recognized. The global market for DEB is estimated to be

$2 Billion.

    About MedAlliance

    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: http://medalliance.com/ 

    Media Contact:  

    Richard Kenyon

    rkenyon@medalliance.com

    +44-7831-569940

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

    Source: MedAlliance