SoniVie, ReCor Move Forward With Ultrasound Renal Denervation Technologies
The FDA granted its breakthrough designation to SoniVie’s TIVUS and ReCor's Paradise ultrasound renal denervation systems for treating hypertension.
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IDE trial of SoniVie’s catheter device will be the first for a denervation treatment for PAH.
Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.
FDA is looking forward to reviewing PMAs from several anti-hypertension devices in the coming years – including technologies from Medtronic, ReCor Medical, ROX Medical, and Vascular Dynamics – so the agency convened its Circulatory System Devices Panel on Dec. 5 to get recommendation on pre-market clinical trial design, post-approval study design, indications and labeling for such devices.