Category: News

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States. The first commercial procedures took place at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City by Drs. Ajay J. Kirtane and Sahil A. Parikh; at the Smidt Heart Institute at Cedars-Sinai in Los Angeles by Drs. Suhail Dohad and Raj Makkar; at Gates Vascular Institute in Buffalo, NY by Dr. Vijay Iyer; and Cleveland Clinic by Dr. Aravinda Nanjundappa.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) system as a treatment for hypertension. Analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN when compared to sham, with fewer antihypertensive treatments added in the treated group. The results were presented in a late-breaking session at Transcatheter Cardiovascular Therapeutics (“TCT”) — the annual scientific symposium of the Cardiovascular Research Foundation — by RADIANCE study co-principal investigator Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. The study results were simultaneously published in Circulation.

Recor Medical, Inc. (“Recor”), a subsidiary of Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), will present data from several clinical studies of the Paradise® Ultrasound Renal Denervation (uRDN) system in the treatment of hypertension at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco.

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 Protection. The new guidelines are designed to serve as a resource on the latest scientific evidence for healthcare professionals around the world who treat people with hypertension. Current rates of treatment and control of hypertension remain suboptimal, and the ESH guidelines assist clinicians and patients in achieving the goal of better health.

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to sham. In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. Results of the pooled analysis showed a consistent blood pressure lowering effect across a broad range of hypertension, including mild to moderate and resistant hypertension.

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the appointment of Lara Barghout as President and Chief Executive Officer of ReCor. Ms. Barghout will lead the ReCor business strategy and organization in an exciting new direction: the global commercialization of ReCor’s Paradise™ Ultrasound Renal Denervation (“uRDN”) System for the treatment of hypertension.

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the filing of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Paradise™ uRDN System in the treatment of uncontrolled hypertension.

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. today announced consistent and significant blood pressure (“BP”) lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. The results come from analysis of the pooled data from ReCor’s RADIANCE Global Clinical Trial Program: three prospectively powered, randomized and sham-controlled clinical trials which evaluated the endovascular Paradise™ Ultrasound Renal Denervation (“uRDN”) System in patients with uncontrolled hypertension. The results were presented at the 2022 American Heart Association (“AHA”) annual meeting by Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and an interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center.