First Patients Treated in Recor Medical’s Global Paradise System US Post Approval Study (US GPS) for the Treatment of Uncontrolled Hypertension with Ultrasound Renal Denervation
25 Julio 2024 - 9:00AM
Recor Medical, Inc. (“Recor”) and its parent company, Otsuka
Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today
announced the first patients in the US 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 (uRDN). Dr. Antonio
“Tony” Gutierrez is the primary study investigator at Durham VA
Medical Center in North Carolina, the first US site in the study to
enroll 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 centers to help advance diversity and
health equity within clinical trials. Building upon the substantial
clinical data generated to-date, which led to US FDA approval of
the Paradise uRDN system in November of 2023, the study will
collect data on patients who undergo treatment with the Paradise
uRDN system. The study seeks to enroll 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 randomized clinical trials, each one
demonstrating that ultrasound RDN is a safe and effective treatment
for hypertension, we enter the next stage with great excitement,”
said study principal investigator 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. “These milestone treatments mark the beginning of a
critical extension—using ultrasound RDN in the real world, focusing
especially on patients who have been underrepresented in trials to
date.”
Hypertension, or high blood pressure, affects nearly half of all
adult Americans. It is known as the “silent killer” because many
people do not know they have it and, over time, it can lead to
serious health issues. About three-fourths of the patients who are
treated for hypertension remain uncontrolled despite making healthy
lifestyle changes and taking multiple medications. Recor Medical’s
Paradise uRDN system is a first-of-its-kind 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 uRDN 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 realize 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 uRDN System in a real-world setting,”
added Recor’s Chief Clinical Officer Helen Reeve-Stoffer.
“Long-term data on the safety and durability of uRDN 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.”
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 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 system in patients with mild-to-moderate and resistant
hypertension. In addition, Recor has begun 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.https://www.recormedical.com/
About Otsuka Medical DevicesOtsuka 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/
# # #Media Contact:Lisa OwensThe Mullings
Grouplowens@mullingsgroup.com+1-210-601-6647
- Paradise™ Ultrasound Renal Denervation (uRDN) system for the
treatment of hypertension
Lara Barghout
Recor Medical
+1 650 542 7700
lara.barghout@recormedical.com