Category: News

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.

May 17, 2025, is World Hypertension Day, a day dedicated to raising awareness about high blood pressure, also known as the “silent killer” because many people do not know they have it and, over time, it can lead to serious health issues. The theme of World Hypertension Day, “Measure Your Blood Pressure Accurately, Control It, Live Longer!” highlights the importance of not only awareness but also accurate monitoring, diagnosis, and treatment of hypertension.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that the Centers for Medicare and Medicaid Services (CMS) have begun a National Coverage Analysis (NCA) of Renal Denervation (RDN), a medical device-based treatment for hypertension.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced U.S. Centers for Medicare & Medicaid Services (CMS) have granted the company’s Paradise® Ultrasound Renal Denervation system a Transitional Pass-through (TPT) payment. The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) have endorsed the updated recommendations for the management of hypertension by the European Society of Cardiology (ESC), which were presented at the ESC Congress on Friday, August 30, 2024. The new guidelines, “2024 ESC Guidelines for the management of elevated blood pressure and hypertension,” have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) greatly appreciate the American Heart Association (AHA) for providing a well-considered statement on the application of renal denervation (RDN) as a therapy option to treat high blood pressure. The AHA scientific statement was based on a balanced literature review of RDN randomized sham-control trials in various patient populations including patients with resistant or uncontrolled hypertension, and provides the medical community a foundation from which to consider RDN a therapy option.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announced today that the Centers for Medicare and Medicaid Services (CMS) published the Final Rule for Fiscal Year 2025 Hospital Inpatient Prospective Payment Systems (IPPS), approving a New Technology Add-On Payment (NTAP) for the Paradise™ Ultrasound Renal Denervation (uRDN) system when performed in the hospital inpatient setting. Availability of the NTAP will begin on October 1, 2024, using the ICD-10-PCS billing code X051329, which is unique to renal denervation procedures involving the Paradise ultrasound system.

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the first patients in the US have been treated in Recor Medical’s Global Paradise® System US Post Approval Study (US GPS), a real-world study gathering data on the long-term safety and effectiveness of ultrasound renal denervation (uRDN). Dr. Antonio “Tony” Gutierrez is the primary study investigator at Durham VA Medical Center in North Carolina, the first US site in the study to enroll and treat patients.

Hypertension, or high blood pressure, affects nearly half of all Americans and more than one billion people worldwide.  Hypertension 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. Hypertension is the number one contributor to the burden of human disease globally and has been associated with a five-year reduction in life expectancy and is a major risk factor for heart disease, stroke, heart attacks and other serious health problems.

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.