Latest news with #ParadiseuRDN
Business Upturn
11-07-2025
- Health
- Business Upturn
Recor Medical Supports Proposed CMS National Coverage Determination of Renal Denervation for the Treatment of Hypertension
Palo Alto, CA, July 10, 2025 (GLOBE NEWSWIRE) — Recor Medical, Inc. ('Recor') and its parent company, Otsuka Medical Devices Co., Ltd. ('Otsuka Medical Devices'), today announced their support for the Centers for Medicare and Medicaid Services' (CMS) proposed National Coverage Determination (NCD) for Renal Denervation (RDN), a device-based therapy for patients with uncontrolled hypertension—individuals whose blood pressure cannot be properly managed with lifestyle changes and medication. The proposed NCD, released on July 10, 2025, recommends coverage for ultrasound renal denervation (uRDN) and radiofrequency renal denervation (rfRDN) for uncontrolled hypertension. A 30-day public comment period is now open for healthcare professionals, professional societies, and industry to provide input before CMS issues its final determination in October. 'We are encouraged by CMS's proposed decision to provide Medicare coverage for uRDN in patients with uncontrolled hypertension—a population that continues to face significant unmet need,' said Lara Barghout, CEO of Recor Medical. 'This preliminary determination is a meaningful step forward in recognizing the clinical value of RDN and will aid in expanding access to the patients who need it.' Recor has been focused on developing and testing the Paradise uRDN system for the treatment of hypertension since 2009. The RADIANCE global program studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an 'off-meds' setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment. Recor has also initiated the US Global Paradise System (GPS) Post-Approval Study, which intends to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension. The Paradise uRDN system is currently commercially available for patients in the US having received FDA approval in November 2023. It is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. About the Paradise uRDN System The Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves. 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. About Recor Medical, Inc. Recor Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise uRDN system is an investigational device in Japan, is FDA approved for sale in the United States, and is CE marked and approved for sale in markets where the CE mark is accepted, per approved indications for use. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System ('GPS') Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States. Recor Medical About Otsuka Medical Devices Co., Ltd. Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. ( a global healthcare company listed on the Tokyo Stock Exchange (JP 4578). Media ContactLisa OwensThe Mullings Group [email protected] +1-210-601-6647
Yahoo
16-05-2025
- Health
- Yahoo
A New Option for Treating High Blood Pressure is Available to United States Veterans
Ultrasound Renal Denervation, a Proven Treatment for High Blood Pressure, is Available to Veterans Thanks to a Partnership Between Recor Medical and Recon Supply ST. CHARLES, Mo., May 16, 2025 /PRNewswire/ -- Hypertension, or high blood pressure, is known as the "silent killer" because many people do not know they have it and, over time, it can lead to serious health issues. In fact, hypertension increases the risk of heart disease and stroke, two of the leading causes of death in the United States. The 2020 Veterans Health Administration (VHA) guidelines on hypertension define uncontrolled hypertension as a reading above or equal to 130/90 mmHg.1 66% of veterans diagnosed with hypertension are considered uncontrolled by the VHA's guidelines.2 Hypertension treatment typically begins with a change in diet, like reducing salt intake, and physical exercise. For some, medication may also be prescribed. However, about one-third of the patients who are treated for hypertension remain uncontrolled despite making healthy lifestyle changes and taking more than three medications. For these patients, medical device-based hypertension therapies, like the Paradise™ Ultrasound Renal Denervation (uRDN) system, may be an additional treatment option. Army veteran Richard Van Name is one such patient who was looking for another way to treat his uncontrolled hypertension. An Army pilot for more than 30 years, Richard noticed his blood pressure was increasing during the later part of his service, and he was diagnosed with hypertension after retirement. Despite adjusting his lifestyle and taking progressively more medications, his blood pressure had not reached a normal level. That's when his physician recommended that he consider the Paradise uRDN treatment, a one-time, safe and minimally invasive procedure that is clinically proven to reduce blood pressure.3-6 "My blood pressure was starting to creep up in the last part of my career, but they were still within the limits for the military. When I was first diagnosed with hypertension, my blood pressure was 178 over 100. Diet and exercise did not bring it down any, and the medication brought it down to around the 150 to 160 region," said Richard. "My cardiologist was not satisfied that the maximum he had prescribed had not brought it down to where he thought was best. The doctor prescribed ultrasound renal denervation, and the procedure had definite results. My wife and I feel a lot better because it relieves us of the chances of heart attack or stroke." The Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy—lasting seven seconds each—through the main renal arteries to the surrounding nerves. 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. This minimally invasive procedure is supported by many medical societies including the American Heart Association, the American College of Cardiology, the European Society of Cardiology and others. Recor Medical—the manufacturer of the Paradise System—has partnered with Service-Disabled Veteran Owned Small Business (SDVOSB) Recon Supply to support the distribution of the Paradise System through the VHA and Department of Defense. Recor has been focused on developing and testing uRDN for the treatment of hypertension since 2009, and completed three independently powered, sham-controlled, randomized clinical trials, all which demonstrate the efficacy and safety of the Paradise System, leading to FDA approval in late 2023. Recor has also initiated the US Global Paradise System (GPS) Post-Approval Study to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension in the United States. The Paradise uRDN system is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. A physician will make a medical assessment to determine if a patient is a candidate for ultrasound renal denervation. The most common risks include pain, vascular access site complications and vasospasm. Full important risk information can be viewed here. Defense DoVAaDo. VA/DoD Clinical Practice Guideline for the Diagnosis and Management of Hypertension in the Primary Care Setting. 2020. Yamada et al. J Hypertens. 2023 Apr 17;41(6):995–1002. Azizi et al. JAMA. 2023;329(8):651-661. Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345. Azizi et al. Lancet. 2021 Jun 26;397(10293):2476-2486. Kirtane et al. JAMA Cardiol. 2023;8(5):464-473. About Recon Supply Recon Supply is an SBA-certified Service-Disabled Veteran Owned Small Business (SDVOSB), demonstrating its commitment to serving the country both in and out of uniform. The company takes pride in its veteran-led team and its dedication to providing exceptional service to military and government clients. For more information on Recon Supply's offerings, visit or contact Recon Supply at 314-317-0300. About Recor Medical, Medical, headquartered in Palo Alto, Calif., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise uRDN system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark. Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension. In addition, Recor is conducting the Global Paradise System ("GPS") Registry in the European Union and the UK, and has initiated the US GPS post-approval study in the United States. Media Contact Katy ClarkEmail - Katy@ View original content to download multimedia: SOURCE Recon Supply
