Innovations in High Blood Pressure Intervention Benefit Patients with Resistant Hypertension

Rhea-AI Summary

On World Hypertension Day, Recor Medical highlights the importance of their Paradise™ Ultrasound Renal Denervation (uRDN) system for treating resistant hypertension. The system, designed to lower blood pressure in patients uncontrolled by standard treatments, uses ultrasound energy to denervate sympathetic nerves around renal arteries. The minimally invasive procedure delivers 2-3 doses of 360-degree ultrasound energy through the main renal arteries, featuring HydroCooling™ technology for arterial wall protection. The technology is supported by major medical societies and has demonstrated efficacy through three independent clinical trials. Recor has initiated the US Global Paradise System Post-Approval Study to collect real-world evidence from 1,000 patients. This innovation addresses a critical need, as WHO reports hypertension cases doubled to 1.3 billion between 1990-2019, with only 42% receiving treatment.

Positive

• System demonstrated efficacy and safety through three independent, sham-controlled clinical trials
• Technology received support from major medical societies including AHA, ACC, and ESC
• Initiated large-scale post-approval study with 1,000 patients for real-world evidence
• Treatment is independent of patient medication adherence
• Procedure typically takes under an hour with lasting BP reductions

Negative

• Procedure carries risks including pain, vascular access site complications, and vasospasm
• Treatment is only indicated as an adjunctive therapy, not a standalone solution
• System requires specific patient candidacy assessment by physicians

World Hypertension Day's focus on High Blood Pressure Awareness, Management and Control highlights Importance of New Therapies, like Ultrasound Renal Denervation from Recor Medical

PALO ALTO, Calif., FRANKFURT, Germany, May 17, 2025 /PRNewswire/ -- May 17, 2025, is World Hypertension Day, a day dedicated to raising awareness about high blood pressure, also known as the "silent killer" because many people do not know they have it and, over time, it can lead to serious health issues. The theme of World Hypertension Day, "Measure Your Blood Pressure Accurately, Control It, Live Longer!" highlights the importance of not only awareness but also accurate monitoring, diagnosis, and treatment of hypertension.

According to a report from the World Health Organization, the number of adults with hypertension doubled between 1990 and 2019 from 650 million to 1.3 billion. The report also states that only 54 percent of adults with hypertension are diagnosed and only 42 percent receive treatment. And recent studies1^,2 have suggested that BP assessment in the clinical setting can often get a hypertension diagnosis wrong or miss it completely. Left undetected or uncontrolled, hypertension is a leading contributor to serious health risks, including heart attack, stroke and kidney disease, making accurate diagnosis, monitoring and treatment of the condition critical.

About one-third of the patients who are treated for hypertension remain uncontrolled despite making healthy lifestyle changes and taking more than three medications. For these patients, innovation and investment in new solutions are vital to achieve blood pressure control and realize a healthier future. From pharmaceutical treatments to technology, patients need new therapies that can provide life-changing results. This includes medical device-based therapies, like the Paradise™ Ultrasound Renal Denervation (uRDN) system, an additional treatment option for patients who remain uncontrolled and at elevated cardiovascular risk despite standard lifestyle changes and treatment with oral medications.

The Paradise uRDN system is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system 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 catheter during the procedure to help protect the renal artery wall. This minimally invasive procedure is supported by many medical societies including the American Heart Association, the American College of Cardiology, the European Society of Cardiology and others.

"Taking a risk-based approach to hypertension makes sense and this is why the medical societies are increasingly behind it," said Prof. Andrew Sharp, University College Dublin and The Mater Misericordiae Hospital, Dublin, Ireland. "Blood pressure reductions of just 5 to 10mmHg can have a significant impact on the risk of cardiovascular complications, such as stroke and heart attack, but gain is greatest in those who are most at risk, such as patients who also have other risk factors for cardiovascular health such as diabetes. Early blood pressure control may also limit the vascular aging process and yet over half of patients worldwide are not even at the basic standard of control of 140/90mmHg. With guidelines now suggesting lower BP targets of 130/80 for many, new treatments in this space are welcome. Renal denervation is a recently approved tool to safely aid in blood pressure lowering throughout the 24-hour cycle and is independent of patient adherence to medication. The procedure shows an excellent safety profile and typically takes under an hour to perform, with lasting BP reductions demonstrated."

Recor Medical – the manufacturer of the Paradise System - has been focused on developing and testing uRDN for the treatment of hypertension since 2009, and completed three independently powered, sham-controlled, randomized clinical trials, all which demonstrate the efficacy and safety of the Paradise System. Recor has also initiated the US Global Paradise System (GPS) Post-Approval Study to collect real-world clinical evidence with long-term follow-up in 1,000 patients with uncontrolled hypertension in the United States.

The Paradise uRDN system is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. A physician will make a medical assessment to determine if a patient is a candidate for ultrasound renal denervation. The most common risks include pain, vascular access site complications and vasospasm. Full important risk information can be viewed here.

*Anatomies vary. See Paradise IFU for treatment strategies.

1. Liu H et al.: Arm Position and Blood Pressure Readings. The ARMS Crossover Randomized Clinical Trial. JAMA Intern Med. 2024;184(12):1436-1442. doi:10.1001/jamainternmed.2024.5213
2. https://newsroom.heart.org/news/high-blood-pressure-while-lying-down-linked-to-higher-risk-of-heart-health-complications

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 uRDN 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 uRDN 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.
http://www.recormedical.com/

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).

https://www.omd.otsuka.com/en/ 

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SOURCE Recor Medical Inc.

FAQ

What is the Paradise uRDN system by Recor Medical (OTSKF) and how does it work?

The Paradise uRDN system is an ultrasound-based renal denervation technology that lowers blood pressure by delivering 2-3 doses of 360-degree ultrasound energy to denervate sympathetic nerves around renal arteries, featuring HydroCooling technology for arterial protection.

What are the clinical results for Recor Medical's (OTSKF) Paradise uRDN system?

The system has demonstrated efficacy and safety through three independent, sham-controlled, randomized clinical trials, and is currently undergoing a post-approval study with 1,000 patients for real-world evidence collection.

Who is eligible for the Paradise uRDN treatment by Recor Medical (OTSKF)?

The treatment is indicated for hypertension patients whose blood pressure is not adequately controlled by lifestyle modifications and antihypertensive medications, subject to physician assessment for candidacy.

What are the risks associated with Recor Medical's (OTSKF) Paradise uRDN system?

The most common risks include pain, vascular access site complications, and vasospasm. The procedure requires specific medical assessment for patient suitability.

How long does the Paradise uRDN procedure by Recor Medical (OTSKF) take?

The procedure typically takes under an hour to perform and provides lasting blood pressure reductions, working independently of patient medication adherence.