TEL AVIV, Israel--(EON: Enhanced Online News)--Cardiosonic Ltd., a privately held company developing innovative and proprietary technology in the field of renal denervation (RDN) for the treatment of hypertension, announced the completion of patient enrollment in its first-in-man (FIM) TIVUS I clinical study. The study is designed to collect data on the safety and performance of the TIVUS™ System, a unique therapeutic ultrasound catheter system for the treatment of hypertension by renal denervation (RDN).
“The performance of renal denervation with an advanced, ultrasonic catheter in TIVUS I was quick, easy and associated with tolerable pain. The TIVUS™ System by Cardiosonic has great potential to become an important technology for management of resistant hypertensive patients.”
The TIVUS™ I clinical program has enrolled 17 patients in 6 Centers in Australia, Israel, and Europe. Sharad Shetty, MD, Principal Investigator at Royal Perth Hospital, Australia commented "The performance of renal denervation with an advanced, ultrasonic catheter in TIVUS I was quick, easy and associated with tolerable pain. The TIVUS™ System by Cardiosonic has great potential to become an important technology for management of resistant hypertensive patients." Full results from the TIVUS trial will be presented in 2014.
Following the TIVUS™ I favorable clinical results the company has started enrollment in a new clinical trial which will enroll ~80 patients at up to 20 sites worldwide. TIVUS II is a prospective, multicenter, non-randomized, 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 6 patients have been enrolled in TIVUS™ II by Dr. Shetty including one patient with failed prior RF ablation.
Dr. Michael Jonas, the Principle Investigator of the TIVUS II trial and medical advisor to the company since its establishment, commented that, “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. This has the potential to improve both the safety and efficacy of RDN.”
Mr. Benny Dilmoney, Cardiosonic CEO commented that, "we are enthusiastic about completing the enrollment of our FIM study and progressing with our 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."
Cardiosonic was founded in 2009 by Shmuel Almagor to develop and commercialize breakthrough ultrasound technology invented by Ariel Sverdlik now the company's Chief Technology Officer. The company has over 20 employees in Tel Aviv, ISRAEL.