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The new ESC Guidelines for Management of Elevated Blood Pressure and Hypertension were presented at the ESC Congress in London and reinforce the safety and effectiveness of renal denervation, recommending its consideration as a treatment option to improve uncontrolled hypertension.
PALO ALTO, Calif. and FRANKFURT AM MAIN, Germany, Sept. 3, 2024 /PRNewswire/ — 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.
Hypertension, or high blood pressure, affects more than one billion people worldwide. 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’s Paradise™ Ultrasound Renal Denervation (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.
“This presented guidance from the ESC Congress 2024 is a big step forward for patients who require a safe and effective option to control hypertension when lifestyle changes and medications are unsuccessful. The recommendation is based on the demonstrated efficacy and safety of renal denervation in randomized sham-controlled trials, and I am very pleased that RDN is now recommended in the ESC Guidelines as a treatment option for refractory and non-adherent patients,” commented Prof. Dr. Michael Böhm, Cardiologist and Clinic Director of Internal Medicine III, Saarland University Hospital in Homburg. “As presented at the congress the ESC guidelines recommend that renal denervation be performed in medium-to-high volume centers after multidisciplinary assessment and with a shared risk benefit discussion with the patient. It is now up to us to implement these guidelines in everyday clinical practice and provide patients with the services they need.”
Recor has completed three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN system in more than 500 patients with uncontrolled hypertension. The RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II clinical studies met their prespecified primary efficacy endpoints of blood pressure reduction, with positive safety outcomes. The Paradise system received CE mark in 2012, and Recor has been actively working with the European cardiology community to bring ultrasound RDN therapy to patients in the region. The growing support of societies like the ESC provides further momentum for the ongoing adoption of Recor’s hypertension therapy.
“We are delighted that the ESC guidelines recommend the consideration of renal denervation as an effective option to treat uncontrolled hypertension,” said Recor President and CEO, Lara Barghout. “The urgent global need to address the burden of uncontrolled hypertension remains, and we’re committed to revolutionizing the way hypertension is treated by bringing the benefits of Paradise ultrasound RDN to patients who need it.”
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 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 Europe GmbH is an Otsuka Medical Devices company.
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/
That press release can be found at https://www.recormedical.eu.
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