Terumo Prospective Registry Reinforces Safety, Efficacy and Efficiency of Radial Access in Visceral Interventions (R.A.V.I.) in Embolization Procedures

Findings show intra-vascular access via the radial artery can successfully be used as the primary strategy for the modern embolization practice

SOMERSET, NJ, March 7, 2023 – Terumo Medical Corporation (TMC) is pleased to announce the final results of its study demonstrating the safety and efficacy of Radial Access in Visceral Interventions (R.A.V.I.) in standard embolization procedures for uterine fibroids, benign prostatic hyperplasia, as well as liver and other hypervascular tumors. The findings were presented on March 7 at the Society of Interventional Radiology (SIR) 2023 Annual Scientific Meeting in Phoenix, AZ. SIR’s annual scientific meeting is the largest professional gathering of interventional radiologists in North America.

The results of the R.A.V.I. Registry — the largest, prospective, multi-center, observational study in vascular and interventional radiology (VIR) — were shared on behalf of study investigators by Marcelo Guimaraes, MD, MBA, FSIR, Professor of Radiology and Surgery, Division of Vascular and Interventional Radiology, Medical University of South Carolina (MUSC). It showed that radial access (RA) can be used as the primary access site for highly relevant and emerging embolization procedures, regardless of disease state (benign or malignant).

Of the 105 patients screened for the study, 99 were successfully enrolled in six U.S. hospitals and treated between February 2020 and January 2022. In addition to MUSC, the other leading IR centers that participated were: The Mount Sinai Hospital, New York, NY; St. Louis University; University of North Carolina at Chapel Hill; Rush University, Chicago, IL; and the University of California, Los Angeles.

The primary safety endpoints included RA-related complications, stroke, myocardial infarction and death at 30 days. The procedural endpoint was defined as successful completion of the intended procedure using RA (i.e., without femoral bailout), which was achieved in 100% of patients. Technical success was 100%, defined as the successful embolization of the target lesion / organ. This prospective registry confirmed the safety and efficacy of RA at 30 days follow-up in visceral embolization procedures. Of the 99 patients in the study, 74 (74.7%) were able to be discharged the same day of their procedure, demonstrating that RA for embolization procedures can create efficiencies in cost management. In addition, newly presented one-year results focus on 70 patients where UFE was performed. The data showed that UFE done transradially allows for fast recovery, presents low risk of bleeding and other complications, and demonstrates sustained improvement in quality of life.

“As we at Terumo continue to explore ways in which to treat our patients, we are proud to demonstrate the benefits of radial artery access — from decreased access-site complications and bleeding to early post-procedure ambulation and discharge — which can now be offered to treat visceral in addition to cardiovascular disease,” said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. “This is yet another way we are contributing to the improvement of future interventional techniques by offering radial solutions to ever-broadening patient populations.” 

“We are proud to announce the one-year results from the biggest cohort of patients where UFE is performed using radial access,” said Dr. Guimaraes. “Safety and effectiveness of this procedure, as shown in this study, should encourage us in our belief that radial access could potentially become preferred for all common embolization procedures.”

For more information on Terumo’s radial solutions, please visit: www.terumois.com/procedural-solutions/radial-edge/procedure.html.