The first patients in the USA have been treated in Recor Medical’s Global Paradise System US Post Approval Study (US GPS), a real-world study gathering data on the long-term safety and effectiveness of ultrasound renal denervation.
Antonio Gutierrez is the primary study investigator at Durham VA Medical Center (Durham, USA), the first US site in the study to enrol and treat patients.
The study will focus on gathering real-world safety and effectiveness data over five years from up to 1,000 patients, collaborating with research centres to help advance diversity and health equity within clinical trials.
Building upon the substantial clinical data generated to-date, which led to US Food and Drug Administration (FDA) approval of the Paradise system in November of 2023, the study will collect data on patients who undergo treatment with the Paradise system.
The study seeks to enrol patients from historically underserved populations in clinical trials, including racially diverse groups, women, and the elderly, along with those having significant comorbidities like chronic kidney disease and diabetes.
Patients will be asked to measure their blood pressure throughout the study, including measuring blood pressure out of the clinic setting using a home monitoring device provided by the study. Participants will also be asked about their quality of life, health, sleep and emotions. Additional demographic data, medical history and socio-economic data may also be collected.
“New therapies to lower blood pressure are desperately needed. Following a rigorous set of randomised clinical trials, each one demonstrating that ultrasound renal denervation is a safe and effective treatment for hypertension, we enter the next stage with great excitement,” said study principal investigator Naomi Fisher (Harvard Medical School, Cambridge, USA and Brigham and Women’s Hospital, Boston, USA). “These milestone treatments mark the beginning of a critical extension—using ultrasound renal denervation in the real world, focusing especially on patients who have been underrepresented in trials to date.”
Recor Medical’s Paradise uRDN system is an 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.
“The launch of the US GPS study for the Paradise ultrasound renal denervation system is an important step in collecting real-world data on the blood pressure lowering impact ultrasound renal denervation can provide,” said Recor president and CEO Lara Barghout. “Patients with uncontrolled hypertension face potentially catastrophic chronic diseases, and new solutions are vital to help them achieve blood pressure control and realise a healthier future. We are proud to be providing this opportunity to Veterans in the US, and we hope to make a meaningful impact on their lives.”
“The US GPS study will build upon the wealth of clinical evidence Recor has generated to show the continued safety and efficacy of the Paradise ultrasound renal denervation system in a real-world setting,” added Recor’s chief clinical officer Helen Reeve-Stoffer. “Long-term data on the safety and durability of ultrasound renal denervation will help further reinforce the impact the therapy can have in lowering blood pressure, and how it can be an important option in the fight to control hypertension.”
