Concept Medical IMPRESSION Trial Evaluates MagicTouch AVF Sirolimus-Coated Balloon in Dysfunctional Fistulas

June 23, 2021—Concept Medical Inc. announced that enrollment is ongoing in the IMPRESSION randomized controlled trial (RCT) of the company’s MagicTouch arteriovenous fistula (AVF) sirolimus-coated balloon angioplasty versus plain old balloon angioplasty (POBA; control arm) in the treatment of dialysis access dysfunction.

The trial is enrolling only patients with end-stage renal disease (ESRD) and a matured dysfunctional AVF that has been in use for at least 1 month before angioplasty. A total of 170 patients with ESRD are being randomized in 1:1 fashion. The trial has enrolled 37 patients since it was commenced on January 11, 2021.

According to the company, IMPRESSION is a prospective, multicenter, two-arm, parallel-group RCT to compare the efficacy of the MagicTouch AVF device and POBA in the treatment of dysfunctional (stenosed) fistula used for vascular access in hemodialysis. The study’s primary objective is to determine if the use of the sirolimus-coated balloon will result in improvement of the primary circuit patency at 6 months when compared head to head with POBA.

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. The other sites are Sengkang General Hospital and National University Heart Center, Singapore. The company noted that Singapore has one of the highest ESRD incident rates globally.

In August 2019, the company announced that the MagicTouch AVF sirolimus-coated balloon was granted Breakthrough Device designation by the FDA. MagicTouch AVF has received CE Mark approval and is commercially available in markets that recognize the CE Mark, advised Concept Medical.