The new ESC Guidelines for Management of Elevated Blood
Pressure and Hypertension were presented at the ESC Congress in
London and reinforce the safety
and effectiveness of renal denervation, recommending its
consideration as a treatment option to improve uncontrolled
hypertension.
PALO
ALTO, Calif. and FRANKFURT
AM MAIN, Germany , Sept. 3,
2024 /PRNewswire/ -- Recor Medical,
Inc. ("Recor") and its parent company, Otsuka Medical Devices
Co., Ltd. ("Otsuka Medical Devices") have endorsed the updated
recommendations for the management of hypertension by the European
Society of Cardiology (ESC), which were presented at the ESC
Congress on Friday, August 30, 2024.
The new guidelines, "2024 ESC Guidelines for the management of
elevated blood pressure and hypertension," have been published
online and recommend the consideration of renal denervation (RDN)
as a safe and effective treatment option for patients who have
uncontrolled resistant hypertension or those that have uncontrolled
hypertension with a higher risk of cardiovascular disease, who
express a preference to undergo RDN.
Hypertension, or high blood pressure, affects more than one
billion people worldwide. 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's
Paradise™ Ultrasound Renal Denervation (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.
"This presented guidance from the ESC Congress 2024 is a big
step forward for patients who require a safe and effective option
to control hypertension when lifestyle changes and medications are
unsuccessful. The recommendation is based on the demonstrated
efficacy and safety of renal denervation in randomized
sham-controlled trials, and I am very pleased that RDN is now
recommended in the ESC Guidelines as a treatment option for
refractory and non-adherent patients," commented Prof. Dr. Michael
Böhm, Cardiologist and Clinic Director of Internal Medicine III,
Saarland University Hospital in Homburg. "As presented at the
congress the ESC guidelines recommend that renal denervation be
performed in medium-to-high volume centers after multidisciplinary
assessment and with a shared risk benefit discussion with the
patient. It is now up to us to implement these guidelines in
everyday clinical practice and provide patients with the services
they need."
Recor has completed three global, independently powered,
sham-controlled randomized clinical trials of the Paradise uRDN
system in more than 500 patients with uncontrolled hypertension.
The RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II clinical
studies met their prespecified primary efficacy endpoints of blood
pressure reduction, with positive safety outcomes. The Paradise
system received CE mark in 2012, and Recor has been actively
working with the European cardiology community to bring ultrasound
RDN therapy to patients in the region. The growing support of
societies like the ESC provides further momentum for the ongoing
adoption of Recor's hypertension therapy.
"We are delighted that the ESC guidelines recommend the
consideration of renal denervation as an effective option to treat
uncontrolled hypertension," said Recor President and CEO,
Lara Barghout. "The urgent global
need to address the burden of uncontrolled hypertension remains,
and we're committed to revolutionizing the way hypertension is
treated by bringing the benefits of Paradise ultrasound RDN to
patients who need it."
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.
Recor Medical Europe GmbH is an Otsuka Medical Devices
company.
https://www.recormedical.com
About Otsuka Medical Devices
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/
That press release can be found
at https://www.recormedical.eu.
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SOURCE Recor Medical Inc.