Advisors on the US Food and Drug Administration’s Circulatory System Devices Panel voted today in support of the premarket approval (PMA) application for the Paradise Ultrasound Renal Denervation ...
In December, the FDA granted breakthrough status for an implantable kidney replacement system for patients with end-stage kidney disease, according to a company press release.The Holly device by ...
A radiofrequency-based renal denervation system for uncontrolled hypertension got a cool reception from FDA advisors who nevertheless left the door open for regulatory approval. On Wednesday, the ...
Credit: Recor Medical. The approval was based on data from the RADIANCE II trial which included patient with mild to moderate hypertension who were adequately controlled with medications. The Food and ...
Credit: Medtronic. The Simplicity Spyral RDN system is designed to lower BP by delivering radiofrequency energy through the wall of the renal artery to denervate the kidney from sympathetic nerve ...
PARIS, France—Two new renal denervation (RDN) systems seem to be safe and effective in patients with uncontrolled hypertension, according to presentations here at EuroPCR 2023. In the SMART trial, a ...
Medtronic suffered yet another disappointment in its relentless pursuit of bringing renal denervation to market for people living with uncontrolled high blood pressure. There seems to be no question ...
The Paradise ultrasound renal denervation system got backing from the FDA's Circulatory System Devices Panel as a possible treatment for hypertension, as manufacturer ReCor continues to hope for ...
Symplicity blood pressure procedure is now covered for qualifying Medicare patients GALWAY, Ireland, Oct. 28, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, ...
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