Statement from the AHA in support of Renal Denervation as a hypertension therapy option provides reinforcement that the treatment can have a meaningful positive impact on the wellbeing of people with resistant or uncontrolled high blood pressure.
Recor Medical’s Paradise Ultrasound Renal Denervation (uRDN) system
Palo Alto, CA, Aug. 19, 2024 – 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.
Renal Denervation for the Treatment of Hypertension: A Scientific Statement from the American Heart Association, was published online in August in the medical journal, Hypertension[1]. The statement describes the AHA’s position on patient selection for RDN and states that RDN should be considered for patients with sustained, uncontrolled hypertension, confirmed with 24-hour ambulatory or home blood pressure measurement. This includes:
- patients with resistant hypertension defined as blood pressure above goal despite concurrent use of 3 anti-hypertensive agents or blood pressure at goal but requiring ≥4 medications
- patients with uncontrolled hypertension despite being on anti-hypertension medications who are intolerant of or unable or unwilling to adhere to their blood pressure medications.
“The AHA Scientific Statement presents an intensive review of trial evidence, followed by clinical considerations and practical recommendations for incorporating RDN into hypertension treatment programs,” said 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, who serves as a consultant for Recor Medical and is a statement co-author. “While more research is needed, most but not all of the new generation randomized RDN control trials reached their primary endpoint, and the procedure carries a favorable safety profile. The AHA statement serves an important role by illuminating RDN as a new treatment option for many patients with uncontrolled hypertension, particularly those with resistant hypertension or who are intolerant to multiple medications.”
Recor has completed three global, independently powered, sham-controlled randomized clinical trials of the Paradise™ Ultrasound Renal Denervation (uRDN) System in more than 500 patients with uncontrolled hypertension. The RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II clinical studies all met their prespecified primary efficacy endpoints of blood pressure reduction, with positive safety outcomes. In addition, Recor is investing in the Global Paradise System Registry, including the Global Paradise System US post-approval study that will continue to monitor the safety and efficacy of the Paradise system.
“We are pleased to see the AHA’s Scientific Statement supporting renal denervation as a therapy option to treat high blood pressure,” said Recor President and CEO, Lara Barghout. “The support of societies like the AHA is incredibly important as we aim to bring our Paradise uRDN system to physicians and patients looking for another way to treat hypertension. It provides further credibility to renal denervation, alongside the evidence we have produced through our world-class clinical trials that shows Paradise uRDN can effectively and safely reduce blood pressure.”
Recor’s Paradise Ultrasound Renal Denervation (uRDN) system received U.S. Food and Drug Administration (FDA) approval as a first-of-its-kind ultrasound-based renal denervation 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.
