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Recor Offers Its Response to the Recently Updated Guidelines for the Management of Arterial Hypertension by the European Society of Hypertension (ESH)

Saturday, July 15, 2023

ReCor Medical, Inc. (ReCor) and its parent company, Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices), welcome the updated and expanded recommendations presented by The European Society of Hypertension (ESH) during their 32nd annual European Meeting on Hypertension and Cardiovascular Protection. These guidelines serve as a valuable resource for healthcare professionals worldwide in the management of arterial hypertension, providing the latest scientific evidence. With the current inadequate rates of hypertension treatment and control, the ESH guidelines are instrumental in assisting clinicians and patients in achieving better health outcomes.

The 2023 European Society of Hypertension (ESH) guidelines for the management of arterial hypertension were recently released. These guidelines, endorsed by the European Renal Association (ERA) and the International Society of Hypertension, provide recommendations on the use of renal denervation as a potential treatment option for certain patients.

According to the guidelines, renal denervation may be considered in the following scenarios:

1. Patients with resistant hypertension who are already taking three or more antihypertensive medications.

2. Patients with uncontrolled hypertension despite receiving combination therapy with antihypertensive drugs.

3.Patients experiencing significant side effects and a reduced quality of life due to their current drug treatment.

The recommendation for renal denervation is based on the positive results observed in various randomized and sham-controlled trials, which have demonstrated both the efficacy and safety of the procedure. The guidelines stress the importance of performing renal denervation in specialized centers with experienced medical professionals, and patient selection should involve a multidisciplinary team.

ReCor Medical, the company behind the Paradise Ultrasound Renal Denervation (RDN) System, has successfully conducted three global, sham-controlled randomized clinical trials involving more than 500 patients with uncontrolled hypertension. These trials, known as RADIANCE-HTN SOLO, RADIANCE-HTN TRIO, and RADIANCE II, have achieved their primary efficacy endpoints related to blood pressure reduction and have shown positive safety outcomes.

Lara Barghout, President and CEO of ReCor Medical, emphasizes that the ESH guidelines validate the experiences of European clinicians who have already been using the Paradise Ultrasound RDN System to achieve meaningful reductions in blood pressure for eligible patients. ReCor Medical is dedicated to revolutionizing hypertension treatment and aims to bring the benefits of ultrasound RDN to patients in need. They have submitted an application for pre-market approval of the Paradise Ultrasound RDN System to the U.S. Food and Drug Administration (FDA) and are working closely with them for its review.

It's important to note that while the Paradise Ultrasound RDN System has received the CE mark for the treatment of hypertension in Europe, it is still under investigation in the United States and Japan.

 

https://www.businesswire.com/news/home/20230714018793/en/ReCor-Responds-to-European-Society-of-Hypertension%E2%80%99s-ESH-Updated-Guidelines-for-Management-of-Arterial-Hypertension

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