AsiaNet 86023

NYON, Switzerland, Oct. 12, 2020 /PRNewswire=KYODO JBN/--

     MedAlliance has announced enrolment of the first two patients in the

PRISTINE registry with SELUTION SLR™ 018 DEB for the treatment of patients with

Below The Knee disease (Chronic Limb Threatening Ischemia). This is the first

DEB accepted by the FDA for its "Breakthrough Program". 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).

Photo: https://mma.prnewswire.com/media/1309965/SELUTION_SLR_Slim.jpg

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

    The PRISTINE registry is a follow up to the encouraging results seen in the

PRESTIGE clinical trial (Below The Knee, Chronic Limb Threatening Ischemia) at

6 months.

    The objective of the registry is to evaluate over 12 months safety and

performance outcomes in 75 patients, with SELUTION SLR DEB in the treatment of

infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb

threatening ischemia (CLTI) at Singapore General Hospital.

    The clinical primary safety endpoint of the registry is freedom from Major

Adverse Events through 30 days and the performance primary endpoint is freedom

from cd-TLR within 6 months. The secondary endpoints are primary patency at 6 &

12 months follow-up, freedom from cd-TLR at 12 months, clinical success at

follow-up in Rutherford score by one class or more, wound healing at 6 months

and freedom from major target limb amputation within 6 and 12 months post index

procedure.

    "We are excited about the commencement of this large single-centre

prospective study focusing on patients with chronic limb threatening ischemia

receiving the novel sirolimus drug eluting balloon (Selution SLR DEB) from

MedAlliance", said Associate Professor Chong Tze Tec, Head & Senior Consultant,

Department of Vascular Surgery, Singapore General Hospital. "We believe this

registry will give us detailed insight into the efficacy & safety of this new

balloon technology which will benefit this challenging group of patients."

    "We are delighted to report enrolment of the first two patients in the

exciting PRISTINE Registry", added Associate Professor Tjun Tang, lead

Investigator and a senior consultant in the Department of Vascular Surgery,

Singapore General Hospital, Singapore. "CLTI represents the worse part of the

spectrum of peripheral artery disease and patients are at an increased risk of

limb loss and mortality. The incidence is likely to increase in Singapore

because of the rising trend in diabetes and end stage renal disease in the

country and these patients are a challenging and frail population of patients.

We currently do far too many major lower limb amputations: in fact the rate in

Singapore is two to three times higher than in western countries. We seriously

need to address this issue. One of the cornerstones of treatment is to

re-establish pulsatile blood flow to the foot to promote wound healing and

although percutaneous lower limb angioplasty has become the favoured option of

revascularization, its Achilles heel is vessel recoil and restenosis from

neointimal hyperplasia".

    The SELUTION Sustained Limus Release DEB offers an effective treatment for

NIH in CLTI and has shown good target lesion patency, low target lesion

revascularisation & relatively high amputation free survival as evidenced from

the 6 months results of the completed PRESTIGE Trial, which was an exploratory

study investigating the efficacy and safety of the same balloon in below the

knee atherosclerotic lesions in the setting of tissue loss at the same hospital.

   "SGH performs over 900 lower limb salvage revascularisation procedures per

year and has established multi-disciplinary wound management protocols and we

are highly encouraged by the pilot data we have found using this technology so

far and PRISTINE will offer further insight, leveraging on our experience with

PRESTIGE, whether this sirolimus coated balloon will become an established

device in our angioplasty armamentarium in the future", concluded Associate

Professor Tang.

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

Chairman and CEO Jeffrey B. Jump. Our breakthrough technology has shown to be

effective & safe in below the knee diseases in highly complex patients in

Singapore as seen in the PRESTIGE trial. We are expecting the same observations

in the PRISTINE registry. SELUTION SLR is designed to deliver the same safety

and performance as best-in-class DES technology with the added benefit of

leaving nothing behind."

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

the treatment of peripheral artery disease. The company recently announced

completion of its below-the-knee (BTK) First-in-Human study in Singapore. The

SAVE Study in Arterial Venus Fistula (AVF) enrolled its first patient in April.

The STEP Pedal Arch study is to commence enrolment this quarter. A 500 patient

post marketing clinical study will follow as well as the US IDE ISR study which

has begun enrolment.

    MedAlliance is the first DEB company in the world to receive US Food and

Drug Administration (FDA) Breakthrough Device Designation Status for a coronary

DEB. SELUTION SLR has now achieved this status for a range of indications: the

treatment of AV-Fistula; coronary in-stent restenosis and peripheral

below-the-knee lesions.

    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™ (Cell

Adherent Technology) enables the MicroReservoirs to be coated onto balloons and

adhere to the vessel lumen when delivered via an angioplasty balloon.

Contact: Richard Kenyon

         rkenyon@medalliance.com  

         +44-7831-569940

Source:  MedAlliance