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SINGAPORE, Jan. 24, 2022 /PRNewswire/ -- Concept Medical Inc., 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 (Concept Medical Inc.) 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, and the IMPRESSION RCT will provide the much needed data.
About Magic Touch - AVF:
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 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.