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 […]
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 […]
Medtronic readies pivotal trial in renal denervation
Medtronic (NYSE:MDT) said today that it’s ready for a run at FDA approval for renal denervation in treating high blood pressure, more than three years after the failure of a high-profile clinical trial. Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of […]
ReCor Medical launches trial for Paradise renal denervation device
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 […]
Baxter launches trial for Vivia home hemodialysis system
Baxter (NYSE:BAX) said today that it’s launching a clinical trial of the Vivia home hemodialysis device it’s co-developing with famed inventor Dean Kamen’s DEKA Research & Development Corp. The Vivia system is designed to provide shorter but more frequent dialysis rounds than conventional dialysis. The device has already won CE Mark approval in the European Union for use with […]
ReCor Medical to launch U.S. trial for Paradise renal denervation device
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 […]
Medtronic gets into renal care with Bellco acquisition
Medtronic (NYSE:MDT) said today that it acquired renal care products make Bellco for an undisclosed amount and plans to fold it into a newly created renal care solutions division. Fridley, Minn.-based Medtronic said Mirandola, Italy-based Bellco makes devices designed to treat end-stage renal failure, multiple organ failure and sepsis, including dialyzers and chronic and acute dialysis machines. The […]
Outset Medical raises $60m for home dialysis device
Renal denervation: Ablative Solutions wins CE Mark for chemical ablation catheter
Ablative Solutions said it received CE Mark approval for its Peregrine infusion ablation catheter for treating uncontrolled hypertension. The company began testing Peregrine last year in Poland.
Renal denervation: Medtronic launches afib trial
Renal denervation: Boston Scientific launches new Vessix trial
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