SoniVie announced that it received FDA breakthrough device designation for its Tivus renal artery denervation technology.
Tivus (therapeutic intra-vascular ultrasound system) is designed for treating resistant hypertension through renal artery denervation. The system previously received breakthrough designation for treating pulmonary arterial hypertension (PAH) in September 2019.
“We are excited about moving the Tivus system into therapeutic areas beyond PAH and believe that the technology has broad utility in a variety of serious health conditions,” SoniVie CEO Dr. Chuck Carignan said in a news release. “A growing body of clinical evidence suggests that our ultrasound-based denervation technology may provide clinical benefit in the treatment of diseases that lack optimal medical management, including resistant hypertension. We believe that the Tivus System can work synergistically with existing treatments to potentially improve clinical outcomes.”
Tel Aviv, Israel-based SoniVie additionally announced that it acquired the remaining intellectual property and other assets related to the Tivus system’s use from Cardiosonic, having previously licensed technology related to its use in the treatment of PAH.
“With breakthrough device designation in two indications and control of the intellectual property and other assets related to the use of the TIVUS System in multiple indications, we have a strong competitive advantage as we work to advance targeted denervation as a therapeutic approach that can provide best-in-class outcomes to patients,” Carignan added.