Medtronic today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension. A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic is now the second company with premarket approval (PMA) to market an RDN system for hypertension in the U.S., following Recor Medical’s approval earlier this […]
Hypertension
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 […]
Medtronic releases new renal denervation results, closes trial enrollment
Medtronic (NYSE:MDT) today said its Symplicity Spyral renal denervation (RDN) system demonstrated durable, clinically significant blood pressure reductions through three years for patients on medication. It’s the latest development out of Medtronic’s Spyral HTN-ON MED trial testing the company’s RDN catheter system, which delivers radiofrequency energy to overactive nerves near the kidneys that cause high blood pressure. […]
MedtronicTalks: Why Symplicity Spyral trials are complicated, but worth it
Medtronic’s campaign to secure FDA approval of its renal denervation device — Symplicity Spyral — has been anything but simple. But in this episode of the MedtronicTalks podcast, Jason Weidman, SVP and president of Coronary & Renal Denervation, explains why the company has refused to give up the fight to develop the renal denervation tool […]
Medtronic builds suspense for renal denervation study results
Medtronic’s clinical study of its Symplicity Spyral renal denervation system for hypertension is likely to go down to the wire for inclusion as a late-breaking clinical trial at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference. The highly anticipated results will offer new insight into the Fridley, Minnesota-based medical device manufacturer’s quest to build a billion-dollar […]
FDA approves Medtronic renal denervation trial in on-med patients
Medtronic (NYSE:MDT) said today that the FDA approved a clinical trial of its Symplicity Spyral renal denervation device in patients who already take medication for their high blood pressure. Fridley, Minn.-based Medtronic said the three-year, 340-patient Spyral HTN-On Med sham-controlled study is designed to compare treatment with the Symplicity Spyral device and a sham procedure, randomized […]
Vascular Dynamics launches pivotal trial for MobiusHD hypertension device
Vascular Dynamics said yesterday that it launched a pivotal trial of its MobiusHD device to treat high blood pressure ahead of a bid for a nod from the FDA. The MobiusHD device is designed to help regulate blood pressure by reshaping the the carotid artery to stimulate baroreceptors and increase the body’s natural response to lower blood […]
Otsuka to acquire renal denervation firm ReCor Medical
Otsuka Holdings (TYO:4578) said today that it plans to acquire the remaining stake it doesn’t already own in ReCor Medical and the renal denervation device it’s developing to treat hypertension. Tokyo-based Otsuka led ReCor’s $15 million Series D in April 2015 to back Palo Alto, Calif.- and Amsterdam-based ReCor’s Radiance-HTN study, which will test its Paradise system in patients […]
ReCor Medical adds another $12m for trial of Paradise renal denervation device
ReCor Medical last week added a $12 million contribution from Otsuka Pharmaceutical (TYO:4578) to the $10 million it raised from the Japanese conglomerate last year for a clinical trial of its Paradise renal denervation device for treating hypertension, ReCor president & CEO Andrew Weiss told MassDevice.com this morning. In May 2016 Otsuka participated in a strategic investment of an unspecified amount; […]
Vascular Dynamics raises $10m for MobiusHD
Vascular Dynamics said this week that it closed a private placement worth $10.4 million that it plans to use on the clinical program for its MobiusHD device for treating drug-resistant hypertension. The MobiusHD implant is designed to reshape the carotid sinus to amplify the signals for baroreceptors lining the blood vessel. Implanted percutaneously, it’s designed to stimulate vasodilation. […]
SteadyMed details commercialization plans for Trevyent
SteadyMed Therapeutics (NSDQ:STDY) today detailed the development of its lead drug product candidate, Trevyent (treprostinil sodium), for the treatment of pulmonary arterial hypertension using its PatchPump tech at the Parenteral Drug Assn. Conference in Huntington Beach, Calif. PatchPump is the 1st single-use, wearable, pre-filled pump and treprostinil will be the 1st drug integrated with the delivery system, according to […]
