PR90263

SINGAPORE, June 23, 2021 /PRNewswire=KYODO JBN/ --

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

intervention drug delivery devices, has updated the progress of IMPRESSION [

https://www.conceptmedical.com/press-release/impression-a-randomised-trial-to-evaluate-the-efficacy-of-magictouch-sirolimus-coated-balloon-in-dysfunctional-fistula-progresses-rapidly/]

(sIroliMus coated balloon angioPlasty versus plain balloon angioplasty in the

tREatment of dialySis acceSs dysfunctION) randomised trial.

   IMPRESSION [

https://www.conceptmedical.com/press-release/impression-a-randomised-trial-to-evaluate-the-efficacy-of-magictouch-sirolimus-coated-balloon-in-dysfunctional-fistula-progresses-rapidly/]

is a prospective, multi-center, two-arm parallel group, randomised clinical

trial to compare the efficacy of Sirolimus Coated Balloon versus Placebo Plain

Balloon (control arm) in the treatment of dysfunctional (stenosed) fistula used

for vascular access in hemodialysis. A total of 170 patients with End Stage

Renal Disease (ESRD) are being randomised in 1:1 fashion (MagicTouch AVF

[https://www.conceptmedical.com/product/magic-touch-avf/]: Placebo Plain

Balloon).

   The study's primary objective is to determine if the use of Sirolimus Coated

Balloon will result in an improvement of the primary circuit patency at six

months when compared head-to-head with plain balloon angioplasty (POBA). The

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

Sirolimus Coated Balloon has already been granted the Breakthrough Device

Designation by the U.S. Food and Drug Administration (FDA). Only ESRD patients

with a matured dysfunctional arterio-venous fistula (AVF) that has been in use

for at least one month prior to angioplasty will be enrolled.

   The study is being conducted at three sites in Singapore led by Associate

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

Medicine, Singapore General Hospital (SGH), as the principal investigator.

Other site principal investigators include Associate Professor Edward Choke,

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

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

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

index patient was enrolled on 11th January 2021 and at the time of going to

press, 37 patients have been enrolled.

   SGH was chosen to lead this randomised controlled trial because of its prior

experience using Sirolimus Coated Balloon in two investigator-initiated pilot

studies. The studies had shown that patency rates with the use of MagicTouch

AVF [https://www.conceptmedical.com/product/magic-touch-avf/] in thrombosed

arterio-venous graft (AVG) and dysfunctional AVF were 65 per cent and 82.9 per

cent at six months, respectively.

   An operational vascular access such as AVF or (AVG) is vital in ESRD

patients for effective and long-term hemodialysis. Unfortunately, due to

various reasons, the AVF or AVG may narrow (stenosis), resulting in poor flow

of the vascular access, which affects hemodialysis. The functional life of an

AVF is poor with as high as 50 per cent chance of failure after a median of

three to seven years.

   Singapore has one of the highest ESRD incident rates globally. POBA is the

current standard treatment for patients with AVF stenosis. Despite the

minimally invasive nature of POBA procedure, the long-term patency is poor,

averaging 40 to 50 per cent at one year. This necessitates multiple procedures

in order to maintain patency of the vascular access.

   Paclitaxel Coated Balloon is also being used to treat dysfunctional AVF with

mixed success. However, the safety concerns of Paclitaxel raised by the U.S.

FDA and the issue of guidelines by the interventional societies have prompted

doctors to seek a better alternative.

Photo:https://mma.prnewswire.com/media/1549682/IMPRESSION_Concept_Medical.jpg

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

   Source: Concept Medical