Palo Alto, Calif. – August 15, 2025 – Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), appreciate the American Heart Association (AHA) and American College of Cardiology (ACC) for highlighting renal denervation (RDN) as a therapeutic option for resistant or uncontrolled hypertension in the joint 2025 Guidelines. The AHA/ACC Guidelines integrate the latest scientific data, regulatory advances, and treatment paradigms into a recommendation for clinicians in the cardiology field, and the 2025 edition emphasizes the growing confidence in RDN as a beneficial treatment option for patients with resistant or uncontrolled hypertension.
The inclusion of RDN, grounded in an objective review of randomized, sham-controlled trials across diverse populations, affirms its relevance and offers healthcare professionals a robust foundation to incorporate this innovative device-based therapy into hypertension management strategies.
“As leading voices in cardiovascular health practices, the AHA and ACC strengthen support for renal denervation as a treatment option for high blood pressure,” said Lara Barghout, President and CEO of Recor. “We are pleased to see that the strength of our RADIANCE Global Program formed the basis for the positive inclusion in the guidelines, which not only reinforce the credibility of this therapy—they directly align with the compelling clinical evidence behind the Paradise® Ultrasound Renal Denervation (uRDN) System, which has consistently demonstrated safe, effective blood pressure reduction.”
“The AHA and ACC’s inclusion of RDN in their latest guidelines is an important step toward integrating and recognizing this therapy as a valuable option for uncontrolled and resistant hypertension,” said Dr. Shon Chakrabarti, Chief Medical Officer of Recor. “We are encouraged that RDN is clearly defined in the treatment pathway for patients with stage 2 hypertension who simply cannot tolerate additional antihypertensive medications.”
The Paradise uRDN System is the first and only FDA-approved ultrasound-based RDN technology designed to reduce blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries. It delivers 360-degree ultrasound energy in two to three seven-second doses, with its proprietary HydroCooling™ system ensuring protection of the renal artery wall during treatment.
Since 2009, Recor has led the charge in developing and clinically validating the Paradise system and the practice of uRDN. Through its comprehensive RADIANCE Global Program, Recor has completed three independently powered, sham-controlled, randomized trials involving over 500 patients:
- RADIANCE II and RADIANCE-HTN SOLO: focused on patients with mild to moderate hypertension in an off-meds setting.
- RADIANCE-HTN TRIO: evaluated patients with resistant hypertension on triple antihypertensive therapy.
All three studies achieved their primary efficacy endpoints and demonstrated a consistently strong safety profile. Building on this success, Recor has launched the U.S. Global Paradise System (GPS) Post-Approval Study, designed to capture real-world, long-term evidence in 1,000 patients with uncontrolled hypertension.
The Paradise Ultrasound Renal Denervation System (Paradise uRDN System) is indicated to reduce blood pressure as an adjunctive treatment in patients with hypertension for whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. Potential procedure-related adverse events including pain, vascular access site complications, and vasospasm are most common. Individual results may vary.
About Recor Medical, Inc.
Headquartered in Palo Alto, Calif., Recor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd. The company is transforming the landscape of hypertension treatment with its groundbreaking Paradise Ultrasound Renal Denervation (uRDN) system — a novel minimally invasive procedure proven to safely reduce blood pressure. The Paradise uRDN system is an investigational device in Japan, is FDA approved for sale in the United States, and is CE marked and approved for sale in markets where the CE mark is accepted, per approved indications for use.
About Otsuka Medical Devices Co., Ltd.
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).
Media Contact
Lisa Owens
The Mullings Group
lowens@mullingsgroup.com
+1-210-601-6647