PR94215

SINGAPORE, Jan. 24, 2022 /PRNewswire=KYODO JBN/ --

    Concept Medical Inc., [https://www.conceptmedical.com/] focused on vascular

intervention drug delivery devices, shares the latest status of its IMPRESSION

(sIroliMus coated balloon angioPlasty versus plain balloon angioplasty in the

tREatment of dialySis acceSs dysfunctION) randomized controlled trial (RCT), as

it crosses the 50 per cent enrollment mark.

    IMPRESSION randomized trial enrolled its index patient on January 11, 2021

to assess the efficacy of Magic Touch Sirolimus Coated Balloon against Placebo

Plain Balloon in dysfunctional fistula. Since then, the prospective,

multi-center, two-arm parallel group RCT continued its trend of enrolling

rapidly, and has already crossed the 50 per cent enrollment mark in just over

10 months.

    The trial, under the lead principal investigator (PI) Associate Professor

Chieh Suai Tan, Head and Senior Consultant, Department of Renal Medicine,

Singapore General Hospital, along with site PIs Associate Professor Edward

Choke, Senior Consultant, Department of Surgery, Sengkang General Hospital, and

Associate Professor Jackie Ho Pei, Senior Consultant, Department of Cardiac,

Thoracic and Vascular Surgery, National University Heart Centre, Singapore,

targets to enroll 170 patients with End Stage Renal Disease (ESRD) and a

matured dysfunctional arterio-venous fistula (AVF) across these three sites.

The primary aim of the trial is to evaluate the primary circuit patency

improvement at six months while comparing the Magic Touch - AVF

[https://www.conceptmedical.com/product/magic-touch-avf/] (Concept Medical Inc.

[https://www.conceptmedical.com/]) and Placebo plain balloon in 1:1 randomized

fashion.

    The trial is doing exceedingly well with 90 patients successfully enrolled

so far; well past the halfway mark. Although the past year was shrouded by

COVID-19, and impacted many healthcare institutions, the rate of enrollment has

not slowed down.

    "I would like to thank all the patients who have participated in the study.

I hope that together, we can find a better treatment to improve your health and

many others who are experiencing the same recurring problem of a dysfunctional

fistula," said Prof Tan.

    Plain balloon angioplasty (POBA) has been the "go-to" procedure. However,

its long-term patency is poor as ESRD patients often experience re-narrowing of

AVF and arterio-venous graft (AVG) due to stenosis. A functioning vascular

access in the AVF and AVG circuit is important for long-term hemodialysis and

POBA seems to be lagging in that aspect. Paclitaxel Coated Balloon is also

being used to treat dysfunctional AVF but with mixed results. Adding to this is

the safety concerns of paclitaxel raised by the U.S. Food and Drug

Administration (FDA).

    The sirolimus coated balloon thus seems to be a promising option as the

Magic Touch - AVF was  granted breakthrough device designation by FDA in 2019

[https://www.conceptmedical.com/press-release/concept-medical-inc-granted-breakt

hrough-device-designation-from-the-fda-for-its-magictouch-avf-sirolimus-coated-b

alloon/], and the IMPRESSION RCT will provide the much needed data.

    About Magic Touch - AVF:

    Magic Touch - AVF [https://www.conceptmedical.com/product/magic-touch-avf/]

is the first drug-coated balloon, that has been granted "Breakthrough Device

Designation" from the U.S. Food and Drug Administration (FDA), for the

treatment of Dysfunctional AVF and AVG. Magic Touch - AVF is a CE approved and

commercially marketed sirolimus coated balloon, developed using proprietary

Nanolute Technology– the drug delivery technology platform of Magic Touch - AVF

balloon, is designed to deliver sub-micron particles of sirolimus designed to

reach the deepest layers of the vessel walls.

    About Concept Medical Inc (CMI):

    CMI [https://www.conceptmedical.com/] is headquartered in Tampa, Florida

and has operational offices in The Netherlands, Singapore and Brazil and

manufacturing units in India. CMI specializes in developing drug-delivery

systems and has unique and patented technology platforms that can be deployed

to deliver any drug / pharmaceutical agent across the luminal surfaces of blood

vessels.

    Photo:

https://mma.prnewswire.com/media/1732298/IMPRESSION_Randomized_Trial_Past.jpg  

    Logo: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg

    Source: Concept Medical