RECOR MEDICAL, INC.


Associated tags: CE, Medicine, FDA, Hypertension, Patient, Pharmaceutical industry, Health, Medical Devices, Blood pressure, Cardiology, Biotechnology, Physician, Clinical Trials, ReCore, TRIO, Mortality, Disease, Hospital, PMA, Surgeon

Locations: CA, UNITED STATES, JAPAN, EU

Recor Medical Announces First Cases of Paradise Ultrasound Renal Denervation Therapy in the United Arab Emirates

Retrieved on: 
Thursday, April 18, 2024
Mortality, Blood pressure, RDN, Death, Arm, Hypertension, Patient, TRIO, Physician, Renal artery, Disease, Pharmaceutical industry

Palo Alto, CA, April 18, 2024 (GLOBE NEWSWIRE) -- Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), announce the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension in the United Arab Emirates (UAE).

Key Points: 
  • Palo Alto, CA, April 18, 2024 (GLOBE NEWSWIRE) -- Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), announce the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension in the United Arab Emirates (UAE).
  • Three cases were performed at Al Qassimi Hospital in Sharjah by Dr. Arif Al Nooryani and Dr. Loai Mousa as second operator.
  • The Paradise uRDN system is a first-of-its-kind ultrasound-based renal denervation (RDN) technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries.
  • Paradise uRDN delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves.

Recor Medical Announces U.S. Launch and First Commercial Cases of Paradise Ultrasound Renal Denervation Therapy

Retrieved on: 
Friday, November 10, 2023
Health, Medical Devices, General Health, Radiology, Clinical Trials, Cardiology, Biotechnology, Medicine, Arm, Food and Drug Administration, Disease, DRS, Hypertension, Food, M.B.B.S, RDN, Physician, Structural heart disease, Surgeon, Mortality, Cardiovascular disease, TRIO, Cleveland Clinic, Multimedia, Patient, Renal artery, Kaleida Health, Division, FDA, Master of Science, Gates Vascular Institute, Intervention, Biomedical sciences, University, MD, Doctor of Philosophy, Hospital, NewYork-Presbyterian Hospital, Blood pressure, Medical imaging, Pharmaceutical industry, Buffalo, Paradise

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.

Key Points: 
  • 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.
  • Paradise uRDN delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves.
  • “This new renal denervation technology for a high-risk patient population – individuals with difficult to control hypertension – has been long awaited.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
Biotechnology, FDA, Medical Devices, Health, Cardiology, JAMA, ReCore, Harvard Medical School, Food, American Medical Association, Blood pressure, Physician, Mortality, MD, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Division, Overactive bladder, Diabetes, RDN, Patient, Associate, Pharmaceutical industry, Endocrinology, Medicine, Brigham

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.

Key Points: 
  • 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.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.
  • The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves.
  • The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
JAMA, FDA, Harvard Medical School, Brigham and Women's Hospital, Food, American Medical Association, Blood pressure, Physician, Mortality, MD, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Division, Treatments for overactive bladder, Diabetes, RDN, Patient, Hospital, Associate, Pharmaceutical industry, ReCore, Endocrinology, Medicine

PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- 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.

Key Points: 
  • Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
    PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- 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.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure.
  • The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
  • Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009.

Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, November 8, 2023
JAMA, FDA, Harvard Medical School, Brigham and Women's Hospital, Food, American Medical Association, Blood pressure, Physician, Mortality, MD, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal, Hypertension, Division, Treatments for overactive bladder, Diabetes, RDN, Patient, Hospital, Associate, Pharmaceutical industry, ReCore, Endocrinology, Medicine

PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- 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.

Key Points: 
  • Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
    PALO ALTO, Calif., Nov. 8, 2023 /PRNewswire/ -- 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.
  • The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure.
  • The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
  • Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009.

Recor Medical Announces Positive Results from Six-Month Pooled Analysis of Data from the RADIANCE Global Clinical Trial Program at TCT 2023

Retrieved on: 
Thursday, October 26, 2023
Health, Clinical Trials, Cardiology, Medical Devices, BP, Surgeon, Blood pressure, TRIO, Hypertension, Physician, Columbia University, NewYork-Presbyterian Hospital, Columbia University Vagelos College of Physicians and Surgeons, Patient, Hospital, Pharmaceutical industry, Circulation, Medicine

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.

Key Points: 
  • 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 RADIANCE Pooled Analysis includes data collected through six months follow-up from 506 patients randomized in the three studies from Recor’s RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension.
  • The combined analysis demonstrated fewer medications were added in the uRDN group at 6 months compared to sham.

Recor Medical to Present Latest Clinical Data on Paradise® Ultrasound Renal Denervation at TCT Annual Meeting

Retrieved on: 
Friday, October 20, 2023
Medical Devices, FDA, Health, Other Health, Clinical Trials, Biotechnology, Randomness, Moscone Center, Blood pressure, Mortality, Medicine, TRIO, Safety, Disease, Abstract (summary), Denervation, Hypertension, Efficacy, Resistance, Abstract, TCT, Patient, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • A late-breaking presentation of a six-month pooled analysis of individual patient data from the RADIANCE™ Global Clinical Trial Program will be presented by Dr. Ajay Kirtane on Thursday, October 26, at 2:00 PM PDT.
  • Six-month results from the RADIANCE II pivotal trial will be presented by Prof. Michel Azizi at 9:27 AM PDT.
  • The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in the United States and Japan.

Recor Medical and Otsuka Medical Devices Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Wednesday, August 23, 2023
Biotechnology, FDA, Health, Medical Devices, Columbia University, Blood pressure, CE, Physician, Multimedia, RDN, Hypertension, PMA, Patient, Surgeon, Disease, Columbia University Vagelos College of Physicians and Surgeons, Mortality, Hospital, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Medicine

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise™ Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

Key Points: 
  • Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise™ Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.
  • The overall vote from the committee was favorable that there was sufficient data to support the use of the device in patients with uncontrolled hypertension.
  • The committee also voted 10 to 2 in favor that the Paradise system benefits outweigh the risks.
  • The Paradise Ultrasound RDN system bears the CE mark for the treatment of hypertension and is an investigational device in the United States and Japan.

ReCor Responds to European Society of Hypertension’s (ESH) Updated Guidelines for Management of Arterial Hypertension

Retrieved on: 
Friday, July 14, 2023
Health, FDA, Medical Devices, Health Technology, Pharmaceutical, Cardiology, Biotechnology, Blood pressure, CE, European Renal Association, Food, ReCore, SOLO, RDN, ERA, Journal, PMA, Patient, European Society for Medical Oncology, International Society on Hypertension in Blacks, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, International Society, Pharmaceutical industry, Medicine, Hypertension

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.

Key Points: 
  • 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.
  • “Recommendation of renal denervation by the recently published European Society of Hypertension (ESH) 2023 Guidelines is a significant milestone for the field of arterial hypertension management.

ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

Retrieved on: 
Tuesday, February 28, 2023
Medical Devices, Health, General Health, Pharmaceutical, Cardiology, Biotechnology, Blood pressure, Safety, Paradise, Patient, American Medical Association, US FDA, Mercury (element), JAMA Cardiology, Journal, FDA, JAMA, Hypertension, BP, US, Pharmaceutical industry

Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to sham.

Key Points: 
  • Study results showed that the Paradise Ultrasound Renal Denervation (uRDN) System successfully reduced blood pressure compared to sham.
  • 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.
  • RADIANCE II is a randomized, sham-controlled US FDA IDE pivotal trial of the Paradise uRDN System in the treatment of patients with uncontrolled hypertension.
  • “ReCor is focused on bringing the Paradise uRDN System to patients and their physicians as a treatment option in the near future.”