PR91132

NYON, Switzerland, Aug. 13, 2021/PRNewswire=KYODO JBN/ --

    MedAlliance has announced completion of patient enrolment in the PRISTINE

clinical trial with SELUTION SLR(TM) 018 DEB (drug-eluting balloon) for the

treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the

first DEB to be awarded "Breakthrough Device Designation" by the FDA.

    PRISTINE is a Prospective Registry to Investigate the Safety and efficacy

of Treatment with SELUTION SLR Sirolimus Drug Coated Balloon in TASC C and D

athero-occlusive Infra-iNguinal disease in patients with chronic limb

threatening ischemia from SingaporE.

    The objective of this trial is to evaluate the safety and efficacy of the

SELUTION SLR DEB in the treatment of infra-inguinal occlusive lesions (TASC C

and D) in patients with chronic limb threatening ischemia in 75 patients over

12 months at Singapore General Hospital.

    PRISTINE is a follow up registry to the PRESTIGE Trial. The 12-month data

from PRESTIGE was presented at LINC 2021 in January, showing sustained benefits

up to one year. 18-month data is to be presented at VIVA in October this year,

where it is anticipated that these benefits will be further sustained. A

similar outcome benefit is expected from PRISTINE in a larger real-world

population.

    BTK represents the worse part of the spectrum of peripheral artery disease

and patients are at an increased risk of limb loss and mortality. One of the

cornerstones of BTK treatment is to re-establish blood flow to the foot to

promote wound healing. Although percutaneous lower limb angioplasty has become

the favored option of revascularization, its Achilles Heel is vessel recoil and

restenosis from neointimal hyperplasia.

    "One of the important things to note is that we had few exclusion criteria,

unlike many of the RCTs using drug coated balloons in the peripheral

vasculature, and the data represent real life lesions that we face every day as

a vascular specialist in Singapore," said Associate Professor Tjun Yip Tang,

Lead Investigator & Senior Consultant, Department of Vascular Surgery,

Singapore General Hospital.

    "PRISTINE will offer further insight, leveraging on our initial experience

with the PRESTIGE Trial, into whether this sirolimus eluting balloon will

become an established device in our angioplasty armamentarium to fight the

neointimal hyperplasia effect and restenosis phenomenon that lead to a

significant number of clinically driven target lesion revascularizations in the

below-the-knee arteries, in this frail and challenging cohort of patients,

whose ischemic foot wounds are difficult to heal."

    "This is an important study for MedAlliance", explained Chairman and CEO

Jeffrey B. Jump. "Our breakthrough technology has demonstrated safety and

efficacy in below-the-knee diseases in highly complex patients as seen in the

PRESTIGE trial. We are expecting similar observations in the PRISTINE registry.

This is particularly encouraging, as to date no other DEB has demonstrated

effectiveness in this challenging patient population."

    In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in

the treatment of Peripheral Artery Disease (PAD) and in May 2020 received CE

Mark approval for treatment in Coronary Artery Disease (CAD).  MedAlliance has

been awarded FDA Breakthrough designation for the SELUTION SLR for use in BTK

and expect to begin the IDE study later this year.  MedAlliance has a robust

global clinical trial program to evaluate outcomes in Coronary, SFA, BTK,

Dysfunctional AVF and Erectile Dysfunction, across different demographic

population groups.

    MedAlliance's DEB 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 for up to

90 days1. 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

   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

   1. Drug concentration evident in MicroReservoirs and tissue – Data on file

at M.A. Med Alliance SA

   Photo: https://mma.prnewswire.com/media/1593621/SELUTION_SLR.jpg  

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

   Source: MedAlliance