TEL AVIV, Israel--(BUSINESS WIRE)--Cardiosonic Inc., a private company developing innovative and proprietary technology in the field of renal denervation (RDN) for the treatment of hypertension, announced the completion of the first phase 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 high intensity, non-focused therapeutic ultrasound catheter system for remote tissue ablation for the treatment of hypertension by renal denervation (RDN).
The study enrolled the first five patients at Royal Perth Hospital (RPH), Australia and patient screening is continuing. Sharad Shetty, MD, Principal Investigator at RPH, completed the procedures with a 100% acute success rate in accessing the vessels and delivering therapy. "The performance of renal denervation with an advanced, ultrasonic catheter has been shown to be quick, easy and seems to be associated with minimal pain. The TIVUS™ System by Cardiosonic has great potential to become an important technology for management of resistant hypertensive patients," commented Dr. Shetty. Dr. Shetty will present interim results from the FIM trial at the Euro PCR conference, Paris, May 21-24 (www.pcronline.com).
The company completed extensive bench and animal studies and following these initial human results is submitting its next human clinical trial to 20 sites worldwide. Dr. Krishna Rocha-Singh, an advisor to the company and a leader in the rapidly growing field of RDN, from the Prairie Heart Institute at the St. John’s Hospital in Springfield, IL, commented that, “The TIVUS™ system has great potential to improve the process and outcomes of RDN procedures. In addition the TIVUS™ system may expand the population of patients eligible for RDN therapy by obviating current anatomic and physiologic restrictions and contra-indications."
Mr. Benny Dilmoney, Cardiosonic CEO, commented that, "We are enthusiastic about completing the first phase of enrollment and progressing towards completion of our FIM patients recruitment and follow-up. Cardiosonic has completed the development of our second generation multi-directional catheter and initiated submission for its study at 20 centers worldwide. We believe that this advanced 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, at the time a doctorate student at Tel Aviv University and now the company's Chief Technology Officer. The company employs 20 people in Ramat Hahayal, Tel Aviv.