PR92199

GENEVA, Oct. 11, 2021 /PRNewswire=KYODO JBN/--

    18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been

presented as a Late Breaking Clinical Trial at VIVA21. The objective of this

clinical investigation has been to evaluate safety and performance outcomes of

SELUTION SLR(TM), MedAlliance's novel sirolimus-eluting balloon, for the

treatment of long tibial occlusive lesions (TASC C & D) in patients with

Critical Limb Ischemia (CLI).

    Freedom from Target Lesion Revascularization (TLR) was exhibited by 88% of

patients and 79% demonstrated Amputation Free Survival (AFS). The rate of wound

healing was 79% and 79% of the patients improved their Rutherford score by at

least one category. The 18-month results have been sustained from the six-month

and twelve-month data.

    PRESTIGE is a prospective, single-center, physician-initiated clinical

study, run at the Singapore General Hospital (SGH) by Associate Professors

Chong Tze Tec and Tang Tjun Yip, Head & Senior Consultant and Senior Consultant

respectively at the Hospital's Department of Vascular Surgery. Twenty-five

patients were enrolled with an average age of 64. 88% had diabetes mellitus and

44% had end stage renal failure. No patients required bailout stenting.

Clinical follow-up was at one, three, six, 12 and 18 months.

    "We have observed minimal slow-flow phenomena, seen with other paclitaxel

drug-eluting balloons.  We have observed several cases of fast wound healing

with SELUTION SLR. It is easy to track and deliver. We are looking forward to

gaining further clinical experience with this device," commented Prof. Chong.

    CLI is a severe obstruction of the arteries which markedly reduces blood

flow to the extremities. It can progress to the point of severe pain and skin

ulcers or sores: CLI often leads to amputation.

    "Singapore has a high percentage of diabetics in its population and CLI

therefore constitutes a major challenge among patients seen with Peripheral

Artery Disease (PAD) who may benefit from this technology," commented Prof.

Tang.  SGH performs over 1,000 interventional procedures a year on patients

suffering from CLI.

    "We are very pleased with the 18-month BTK results in this very difficult

patient population," added MedAlliance Chairman and CEO Jeffrey B. Jump. "This

complements the excellent results we have seen in SFA, AVF and coronary

patients".

    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. The US FDA has awarded SELUTION SLR with four breakthrough

designations: for the treatment of atherosclerotic lesions in native coronary

arteries; coronary in-stent restenosis; peripheral below-the-knee and

AV-Fistula indications.

    In August 2021, the first of over 3,000 patients was enrolled in a

ground-breaking coronary randomized controlled study comparing SELUTION SLR

with a limus drug-eluting stent [DES]. This is the largest DEB study ever

initiated and has the potential to change medical practice.

    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.

    * Physician initiated, prospective, non-Randomized single-center trial,

investigating the safety and Efficacy of the Treatment with the Selution

Sirolimus Coated Balloon in TASC C and D Tibial occlusive disease In patients

with critical limb Ischemia from SinGaporE.

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

at M.A. Med Alliance SA

    Media Contact:

    Richard Kenyon

    kenyon@medalliance.com

    +44 7831 569940

    About MedAlliance

    MedAlliance is a privately-owned medical technology company. It is

headquartered in Nyon, Switzerland, with offices in Germany, Singapore, UK and

USA. 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

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

    Photo: https://mma.prnewswire.com/media/1655829/Selution_SLR_BTK_Data.jpg

    Source: MedAlliance