Medtronic and Recor Medical each announced separate Medicare reimbursement approvals for their respective renal denervation (RDN) technologies. Going into effect on Jan. 1, 2025, the approvals could increase patient access to the new hypertension treatments. Medtronic secured a Transitional Pass-Through (TPT) payment under the Medicare Hospital Outpatient Prospective Payment System for its Symplicity Spyral renal […]
renal denervation
Medtronic reports positive long-term renal denervation outcomes
Medtronic (NYSE:MDT) today announced new, long-term study data further supporting its Symplicity Spyral renal denervation (RDN) system. Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure. The RDN system holds approval for commercial use in more […]
Medtronic renal denervation system recognized on ‘Change the World’ list
Medtronic announced today that Fortune named it to its 2024 “Change the World” list for its Symplicity blood pressure procedure. The annual list showcases companies making a difference to combat global issues and drive positive social or environmental change, Medtronic says. Medtronic received recognition for its Symplicity procedure, which utilizes the Symplicity Spyral renal denervation […]
DeepQure wins FDA IDE nod for renal denervation study
DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system. The Seoul, South Korea–based company designed HyperQure to perform renal denervation (RDN) through an extravascular (laparoscopic) approach. DeepQure says it’s the world’s first extravascular RDN medical device for treating resistant hypertension. Though it faced clinical trial […]
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 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 […]
