Israel-based Cardiosonic announced it is currently enrolling patients in the TIVUS II clinical trial, designed to assess the safety, efficacy and performance of its TIVUS system using a next generation multidirectional catheter.
TIVUS system is a therapeutic ultrasound catheter system indicated for hypertension by renal denervation (RDN).
The non-randomized TIVUS II trial, which currently enrolled six patients, will enroll up to 80 patients at around 20 sites globally.
TIVUS II study includes a cohort of previously treated non-responding RF renal denervation patients.
The TIVUS II trial follows the company’s successful completion of patient enrollment in its first-in-man TIVUS I clinical study, designed to evaluate the safety and performance of the TIVUS system.
Following the positive clinical results from the TIVUS I clinical study, the company has started enrollment in the TIVUS II study.
TIVUS I trial has been designed assess the safety and performance of the TIVUS system.
A total of 17 patients at six centers in Australia, Israel, and Europe have been enrolled in the TIVUS I clinical study.
Cardiosonic CEO Benny Dilmoney noted the company is enthusiastic about completing the enrollment of our FIM study and progressing with its clinical program.
"Cardiosonic has completed the development of our second generation user friendly multi-directional catheter and initiated enrollment for the TIVUS II study at several centers worldwide. We believe that this next generation catheter design will further improve RDN procedures," Dilmoney added.