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. […]
renal denervation
The top medtech trends of 2023
The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods. With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more. Here are the top stories […]
Ablative Solutions hits primary endpoint in renal denervation for hypertension trial
Ablative Solutions announced today that its TARGET BP I pivotal trial evaluating its Peregrine System kit met its primary endpoint. The trial evaluates alcohol-mediated renal denervation to treat hypertension with the Peregrine System. Wakefield, Massachusetts-based Ablative Solutions reported a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedure at three months. […]
Medtronic reports first patient treated with Symplicity Spyral renal denervation system
Medtronic announced that doctors completed the first commercial case in the U.S. with its Symplicity Spyral renal denervation (RDN) system. Also known as the Symplicity blood pressure procedure, Symplicity Spyral treats high blood pressure, or hypertension. The first procedure follows the landmark approval for the system earlier this month. Approval made Medtronic the second company […]
What’s next for Medtronic’s RDN program after FDA approval?
Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension. In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the […]
FDA approves Medtronic’s Symplicity Spyral renal denervation system
Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. [Update: Read more of our coverage from the weeks following the approval, including Medtronic’s lessons learned, what’s next for the technology, and other potential applications.] A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic […]
Recor Medical launches renal denervation system, announces first commercial cases
Recor Medical announced the first commercial uses of its Paradise ultrasound renal denervation (uRDN) system for treating hypertension. The first commercial uses follow the company’s landmark FDA approval for Paradise last week. Approval allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to control a patient’s blood […]
Recor Medical wins first FDA nod for renal denervation to treat hypertension
Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension. The long-awaited approval for the Otsuka Medical Devices portfolio company allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to adequately control a patient’s blood pressure. Paradise had looked the […]
Recor Medical presents more data supporting its renal denervation system
Otsuka Medical Devices’ Recor Medical announced another set of positive study results for its Paradise ultrasound renal denervation (uRDN) system. A combined analysis of six-month follow-up data from three RADIANCE global studies evaluated Paradise as a hypertension treatment. The analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN compared to sham. It also […]
Medtronic stock is down on new RDN system setback
Medtronic stock is taking a hit after an FDA review panel found the risks of its renal denervation system outweighed the benefits. The world’s largest medical device company engaged in more than a decade of clinical trials and research — with multiple disappointments along the way — as it made a bet that its radiofrequency-energy-based […]
ReCor Medical wins FDA panel nod for its renal denervation system
ReCor Medical announced that an FDA panel has voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. On Aug. 22, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 12–0 in favor with regard to safety and 8–3 in favor, with […]