Terumo Registry Evaluates Radial Access in Visceral Interventions in Embolization Procedures

March 13, 2023—Terumo Medical Corporation announced 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 behalf of the study investigators by Marcelo Guimaraes, MD, at SIR 2023, the Society for Interventional Radiology’s annual scientific meeting held March 4-9, 2023, in Phoenix, Arizona. Dr. Guimaraes is Professor of Radiology and Surgery, Division of Vascular and Interventional Radiology, at Medical University of South Carolina (MUSC) in Charleston, South Carolina.

According to Terumo, the R.A.V.I. Registry is a prospective, multicenter, observational vascular and interventional radiology (IR) study. The results demonstrated 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 patients were successfully enrolled and treated at six hospitals in the United States between February 2020 and January 2022.

In addition to MUSC, the other IR centers in the trial were: Mount Sinai Hospital in New York, New York; St. Louis University in St. Louis, Missouri; University of North Carolina at Chapel Hill in Chapel Hill, North Carolina; Rush University in Chicago, Illinois; and the University of California, Los Angeles, in Los Angeles, California.

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 (ie, without femoral bailout).

The procedural endpoint was achieved in 100% of patients. Technical success was 100%, defined as the successful embolization of the target lesion/organ.

The 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 1-year results focus on 70 patients where uterine fibroid embolization (UFE) was performed. The data showed that transradial UFE allows for fast recovery, presents low risk of bleeding and other complications, and demonstrates sustained improvement in quality of life.

“We are proud to announce the one-year results from the biggest cohort of patients where UFE is performed using radial access,” commented 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.”