Israel-based Cardiosonic has completed the patient enrolment in the first-in-man (FIM) TIVUS I clinical study of its high-intensity, therapeutic ultrasound catheter system, developed for the treatment of hypertension by renal denervation (RDN).
Designed to collect data on the safety and performance of the TIVUS system, the TIVUS I clinical study has enrolled the first five patients at Royal Perth Hospital (RPH) in Australia.
The TIVUS I clinical programme has enrolled 17 patients totally in six centres in Australia, Israel, and Europe.
Following the fruitful results from TIVUS I, Cardiosonic has initiated enrolment of patients in a new prospective, multicentre, non-randomised, single-arm, open-label clinical study called TIVUS II.
It is designed to further assess the safety, efficacy and performance of the TIVUS system using a next generation multidirectional catheter.
TIVUS II is expected to recruit approximately 80 patients at up to 20 sites worldwide.
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The new study includes a cohort of previously treated non-responding RF renal denervation patients.
Cardiosonic medical advisor and principle investigator of the TIVUS II trial Dr Michael Jonas said the TIVUS system has great potential to improve the process and outcome of RDN procedures.
"Overall, the TIVUS System enables rapid delivery of ultrasonic energy without contacting the vessel wall," Dr Jonas said. "This has the potential to improve both the safety and efficacy of RDN."
To date six patients have been enrolled in TIVUS II, including one patient with failed prior RF ablation by Dr Sharad Shetty, principal investigator at Royal Perth Hospital, Australia.
Cardiosonic CEO Benny Dilmoney said the company is enthusiastic about completing the enrolment of its FIM study and progressing with our clinical programme.
"Cardiosonic has completed the development of our second generation user friendly multi-directional catheter and initiated enrolment for the TIVUS II study at several centres worldwide," Dilmoney said.
According to the company, the full results from the TIVUS trial will be presented in 2014.