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. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon during the procedure to help cool and protect the inner layers of the renal artery.
“Around the world, hypertension is one of the most dangerous cardiovascular conditions, sometimes leading to heart attack and death. Many people are not even aware of their high blood pressure, and some patients taking antihypertensive medications remain uncontrolled or don’t stay adherent. Renal Denervation is a well-studied treatment and is now recommend in several medical society guidelines as a therapy option for uncontrolled hypertension,” said Dr. Arif Al Nooryani, CEO and Head of the Cardiac Cath Lab at Al Qassimi Hospital Sharjah. “We are pleased to be the first hospital in the Middle East to offer ultrasound renal denervation to our patients.”
“Recor is grateful to Dr. Al Nooryani, Dr. Mousa and Al Qassimi Hospital for bringing Paradise uRDN therapy to their patients in the United Arab Emirates,” said Lara Barghout, President and CEO of Recor Medical. “These first cases in the Middle East are an important initial step toward reaching the many physicians and patients in the region who are looking for another treatment option for uncontrolled hypertension.”
Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems. About one-third of the patients treated for hypertension remain uncontrolled despite lifestyle changes and taking more than three medications. The Paradise uRDN system is an adjunct treatment option for patients who have been unable to achieve blood pressure goals with standard lifestyle changes and oral medications.
The Paradise uRDN system was tested through Recor’s RADIANCE Global Program of three rigorous prospectively powered and sham-controlled randomized controlled clinical trials: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-to-moderate hypertension. Each trial successfully met its prespecified primary efficacy endpoint, showing statistically significant and clinically meaningful blood pressure reductions compared to a sham arm and favorable safety profiles.
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 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 system in patients with mild-to-moderate and resistant hypertension. In addition, Recor has begun the Global Paradise System (“GPS”) Registry in the European Union and the UK, with plans to expand globally.
About Otsuka Medical Devices
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. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).
