FIM IVUS I Completes Enrolment; TIVUS II Begins Enrolment
Cardiosonic has reported the completion of patient enrolment in its first-in-man (FIM) TIVUS I study. The study is designed to collect data on the safety and performance of the company's Tivus system, a therapeutic ultrasound catheter system for the treatment of hypertension by renal denervation. The TIVUS I clinical programme has enrolled 17 patients in six centres in Australia, Israel, and Europe. Full results from the TIVUS trial will be presented in 2014.
Following favourable clinical results from TIVUS I, Cardiosonic has started enrolment in a new clinical trial that will enrol approximately 80 patients at up to 20 sites worldwide. TIVUS II is a prospective, multicentre, non-randomised, single-arm, open-label clinical study and will further assess the safety, efficacy and performance of the Tivus system using a next-generation multidirectional catheter. TIVUS II includes a cohort of previously treated non-responding RF renal denervation patients. To date six patients have been enrolled in TIVUS II by Dr Sharad Shetty, Principal Investigator at Royal Perth Hospital, Australia, including one patient with failed prior RF ablation.