IMPRESSION Randomized Trial: Past the Halfway Mark and Progressing Rapidly

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 percent 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 percent 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 arteriovenous 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 are 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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy