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First Patients Treated in Recor Medical’s Global Paradise System US Post Approval Study (US GPS) for the Treatment of Uncontrolled Hypertension With Ultrasound Renal Denervation
Durham VA Health Care System in North Carolina is the first site in U.S. to enroll and treat patients in the study collecting real-world data on long-term safety and effectiveness of the Paradise® Ultrasound Renal Denervation System.
Durham VA Health Care System in North Carolina is the first site in U.S. to enroll and treat patients in the study collecting real-world data on long-term safety and effectiveness of the Paradise® Ultrasound Renal Denervation System.
Recor Medical, Inc., News
Palo Alto, Calif. – Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. announced the first patients in the U.S. 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.
The study will focus on gathering real-world safety and effectiveness data over five years from up to 1,000 patients, collaborating with research centers to help advance diversity and health equity within clinical trials. Building upon the substantial clinical data generated to-date, which led to US FDA approval of the Paradise uRDN system in November of 2023, the study will collect data on patients who undergo treatment with the Paradise uRDN system. The study seeks to enroll patients from historically underserved populations in clinical trials, including racially diverse groups, women, and the elderly, along with those having significant comorbidities like chronic kidney disease and diabetes.
Patients will be asked to measure their blood pressure throughout the study, including measuring blood pressure out of the clinic setting using a home monitoring device provided by the study. Participants will also be asked about their quality of life, health, sleep and emotions. Additional demographic data, medical history and socio-economic data may also be collected.
“New therapies to lower blood pressure are desperately needed. Following a rigorous set of randomized clinical trials, each one demonstrating that ultrasound RDN is a safe and effective treatment for hypertension, we enter the next stage with great excitement,” said study principal investigator Naomi Fisher, MD, Associate Professor of Medicine, Harvard Medical School, and Director of Hypertension Service and Hypertension Innovation, Division of Endocrinology, Diabetes and Hypertension at Brigham and Women’s Hospital. “These milestone treatments mark the beginning of a critical extension—using ultrasound RDN in the real world, focusing especially on patients who have been underrepresented in trials to date.”
Hypertension, or high blood pressure, affects nearly half of all adult Americans. It 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. About three-fourths of the patients who are treated for hypertension remain uncontrolled despite making healthy lifestyle changes and taking multiple medications. Recor Medical’s Paradise uRDN system is a first-of-its-kind ultrasound-based renal denervation technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries in patients whose hypertension is not controlled by medications alone.
“The launch of the US GPS study for the Paradise uRDN System is an important step in collecting real-world data on the blood pressure lowering impact ultrasound renal denervation can provide,” said Recor President and CEO Lara Barghout. “Patients with uncontrolled hypertension face potentially catastrophic chronic diseases, and new solutions are vital to help them achieve blood pressure control and realize a healthier future. We are proud to be providing this opportunity to Veterans in the US, and we hope to make a meaningful impact on their lives.”
“The US GPS study will build upon the wealth of clinical evidence Recor has generated to show the continued safety and efficacy of the Paradise uRDN System in a real-world setting,” added Recor’s Chief Clinical Officer Helen Reeve-Stoffer. “Long-term data on the safety and durability of uRDN will help further reinforce the impact the therapy can have in lowering blood pressure, and how it can be an important option in the fight to control hypertension.”
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, and has initiated the US GPS post-approval study in the United States.
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).
https://www.omd.otsuka.com/en/
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