Boston Scientific announced today that it agreed to acquire intravascular ultrasound system developer SoniVie. This acquisition could bring Boston Scientific into the now-competitive renal denervation (RDN) space. Recor Medical received a landmark FDA nod for its Paradise ultrasound-based RDN system in November 2023. Medtronic became the second company with such approval, receiving its nod for the […]
SoniVie
SoniVie completes enrollment in trial of ultrasound renal denervation for hypertension
SoniVie announced today that it treated the last patient in a pilot study of its Tivus technology for renal artery denervation to treat hypertension. Tel Aviv, Israel-based SoniVie develops Tivus (therapeutic intra-vascular ultrasound) to treat a variety of hypertensive disorders. It’s conducting the REDUCED-1 FDA investigational device exemption study to evaluate the renal denervation technology. […]
The top 10 catheter innovations of 2020
As the COVID-19 pandemic took over the world in 2020, medical device companies continued to showcase new catheter innovations. Throughout 2020, we saw FDA clearances, approvals and product launches for a variety of catheter-based technologies, including renal denervation systems, heart failure treatment catheters, mechanical thrombectomy systems and more. The list includes some medtech giants like […]
SoniVie wins FDA breakthrough nod for renal denervation tech
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. Get the full story at our sister site, Medical Tubing & […]
SoniVie wins FDA breakthrough device designation for pulmonary hypertension device
SoniVie last week won FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension. The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, according to the company. It is inserted into the pulmonary artery during right heart catheterization and is […]
