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FDA approves Medtronic renal denervation trial in on-med patients

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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

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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

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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

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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

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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

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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 […]

Ablative Solutions wins FDA nod for Phase II chemical denervation trial

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Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application. The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control […]

Rox Medical raises $40m Series E for hypertension ‘stent’

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Rox Medical said today that it raised a $40 million Series E round for the stent-like Coupler device it developed to treat hypertension by connecting the femoral artery and the femoral vein. The round was led by the Novartis Venture Fund and Apple Tree Partners, with participation from prior backers Versant Ventures and Domain Associates, San Clemente, Calif.-based Rox said. […]

Renal Dynamics launches post-market trial for Redy 3rd-gen renal denervation device

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Renal Dynamics said it launched a post-market study of its Redy renal denervation device for treating hypertension, after winning CE Mark approval for the device last November. Zug, Switzerland-based Renal Dynamics, which is owned by the Hobart Group, said the 1st patient in the trial was successfully treated at Novosibirsk, Russia’s Meshalkin State Research Institute of Circulation Pathology. […]

ReCor Medical launches trial for Paradise renal denervation device

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ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension. The blinded, randomized and sham-controlled trial is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. The trial […]

ReCor Medical to launch U.S. trial for Paradise renal denervation device

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ReCor Medical said today that it won an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device for treating high blood pressure. Palo Alto, Calif., and Amsterdam-based ReCor said the 292-patient Radiance-HTN study, a blinded, randomized and sham-controlled trial, is designed to evaluate the Paradise system in patients with essential hypertension […]

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