Recor Medical Responds to the American Heart Association’s (AHA) Scientific Statement on Renal Denervation for the Treatment of Hypertension
19 Agosto 2024 - 8:00AM
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.
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 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/
Media Contact
Lisa OwensThe Mullings
Grouplowens@mullingsgroup.com+1-210-601-6647
[1] Jennifer L. Cluett, MD, FAHA, Chair, Olivia Blazek, MD,
Angela L. Brown, MD, Cara East, MD, Keith C. Ferdinand, MD, FAHA,
Naomi D.L. Fisher, MD, Cassandra D. Ford, PhD, FAHA, Karen A.
Griffin, MD, FAHA, Carlos I. Mena-Hurtado, MD, FAHA, Harini
Sarathy, MD, MHS, Wanpen Vongpatanasin, MD, FAHA, and Raymond R.
Townsend, MD, FAHA, Vice Chair on behalf of the American Heart
Association Council on Hypertension; Council on Cardiovascular and
Stroke Nursing; Council on the Kidney in Cardiovascular Disease;
and Council on Peripheral Vascular Disease). Hypertension.
2024;81:e00–e00. doi: 10.1161/HYP.0000000000000240.
- Recor Medical's Paradise Ultrasound Renal Denervation (uRDN)
system
Lara Barghout
Recor Medical
+1 650 542 7700
lara.barghout@recormedical.com