DUBLIN, Aug. 23, 2023 /PRNewswire/ — Today, Medtronic announced the outcome of the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral™ Renal Denervation (RDN) System. The panel Committee voted unanimously (13-0) on safety and in favor (7-6) […]
Tag: Renal Denervation
ReCor Responds to European Society of Hypertension’s (ESH) Updated Guidelines for Management of Arterial Hypertension
PALO ALTO, Calif.–(BUSINESS WIRE)–ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) are pleased to see the updated and expanded recommendations for the management of arterial hypertension that The European Society of Hypertension (ESH) presented at their 32nd annual European Meeting on Hypertension and Cardiovascular […]
Verve Medical Announces FDA Approval of IDE for Pivotal Trial of RPD™ Renal Pelvic Denervation System for Treatment of Uncontrolled Hypertension
PHOENIX–(BUSINESS WIRE)–Verve Medical, Inc. (Verve) announced today that the Company has received approval from the US Food & Drug Administration (FDA) to initiate its Natural Orifice via renal pelvis denervation (NOVEL- Denervation) Pivotal IDE trial for the treatment of uncontrolled hypertension to lower blood pressure. “This Pivotal trial is designed […]
ReCor Medical Announces FDA Approval Of IDE For Pivotal Study Of Paradise® Ultrasound Denervation System For Treatment Of Hypertension
PALO ALTO, Calif., July 2, 2018 /PRNewswire/ — ReCor Medical announced today that the US Food & Drug Administration approved the Company’s new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II. Building upon the recent positive results of the Company’s RADIANCE-HTN SOLO study, RADIANCE-II will be […]
ReCor Medical Announces Completion of RADIANCE-HTN SOLO Hypertension Study
PALO ALTO, Calif., Jan. 5, 2018 /PRNewswire-USNewswire/ — ReCor Medical announced today randomization of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, ReCor’s study of its Paradise Renal Denervation System in people with hypertension, involves two study cohorts: “SOLO” – whose subjects are removed from anti-hypertensive […]
ReCor Medical Announces 1000th Enrollment and 150th Randomization in RADIANCE-HTN Hypertension Study
PALO ALTO, Calif., Oct. 30, 2017 /PRNewswire-USNewswire/ — ReCor Medical announced progress milestones in the study of its Paradise® Renal Denervation System as a potential treatment for hypertension, including the 1000th consented and the 150th randomized subjects in the RADIANCE-HTN study, and publication of a study design review in the American Heart […]
Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions
Published Simultaneously in The Lancet, the Late-Breaking SPYRAL HTN-OFF MED Study at ESC Successfully Isolates RDN Treatment Effect to Show Compelling Efficacy and Safety of Hypertension Procedure DUBLIN and BARCELONA – August 28, 2017 – Medtronic plc (NYSE:MDT) today announced its intent to move forward with a new renal denervation pivotal trial […]
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