CardioSonic has completed the first phase of patient enrolment in the first-in-man (FIM) clinical study of its high intensity, non-focused therapeutic ultrasound catheter system, used for the treatment of hypertension by renal denervation (RDN).
Comprised of a 0.014-inch guidewire-based TiVUS catheter, a TIVUS control console and a 6-F flexible introducer sheath, the TIVUS system is advanced into the renal artery under fluoroscopic guidance and positioned within the vessel lumen for remote tissue ablation.
The procedure, which is anticipated to reduce blood pressure, is expected to take fewer than ten minutes of time to perform.
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.
Royal Perth Hospital principal investigator Sharad Shetty said 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," Shetty added.
Prairie Heart Institute RDN interventional cardiologist Krishna Rocha-Singh said 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," Rocha-Singh added.
Cardiosonic CEO Benny Dilmoney said with the completion of first phase of enrolment, the company is progressing towards completion of its FIM patients recruitment and follow-up.
"Cardiosonic has completed the development of our second generation multidirectional catheter and initiated submission for its study at 20 centres worldwide," Dilmoney added.
"We believe that this advanced catheter design will further improve RDN procedures."