Cardiosonic Ltd. said it’s completed a 1st-in-human trial of its Tivus renal denervation device and has launched a 2nd trial.
The Tel Aviv-based medical device company is developing the Tivus device to treat high blood pressure using renal denervation. Unlike other renal denervation technologies that use radiofrequency energy to ablate the nerve lining the renal arteries, the Tivus device uses ultrasound waves.
Results from the 17-patient 1st-in-human trial are slated to be presented in 2014, Cardiosonic said.
Cardiosonic has begun enrollment in the 2nd trial, Tivus II, a single-arm, prospective, non-randomized, open-label study with roughly 80 patients. It’s designed to evaluate the safety, efficacy and performance of the Tivus device, including a cohort of subjects who did not respond to previous renal denervation using RF ablation.
"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," Tivus II principle investigator Dr. Michael Jonas said in prepared remarks.