PALO
ALTO, Calif., Nov. 17,
2022 /PRNewswire/ -- Varian, a Siemens Healthineers
company, announced today that the first trial participant has been
treated as part of GENESIS II (Genicular artEry
embolisatioN in patiEnts with
oSteoarthrItiS of the knee), a study of
Embozene® microspheres for genicular artery
embolization (GAE) as treatment of mild to moderate knee
osteoarthritis. GENESIS II is the largest randomized clinical trial
of GAE to assess pain relief from this debilitating condition.
GENESIS II is being conducted at the University Department of
Radiology, Royal Berkshire NHS Foundation Trust, in Reading, UK. The trial targets mild to
moderate osteoarthritis (OA) of the knee joint, a common condition
and a leading cause of chronic disability. GAE is a minimally
invasive procedure in which a small catheter is advanced into the
genicular arteries, the small blood vessels that supply the knee
joint and contribute to the inflammatory process. The Embozene
microspheres are delivered through the catheter to reduce the blood
supply to the areas of greatest inflammation in the knee with the
goal of reducing pain.
In the GENESIS II clinical trial, patients with knee
osteoarthritis will either receive treatment with the Embozene
microspheres or a sham control; they have the option to receive
Embozene treatment later in the clinical trial. This clinical trial
design allows more accurate assessment of pain relief from the new
treatment.
In October 2021, the U.S. Food and
Drug Administration (FDA) granted Breakthrough Device Designation
for Embozene microspheres for GAE for OA. The medical device is
marketed in 60 countries for embolization, a procedure that blocks
or reduces blood supply to a target area in the body. Currently,
Embozene is used to treat hypervascular tumors, arteriovenous
malformations, uterine fibroids, and benign prostatic hyperplasia.
Embolics are not yet authorized for marketing anywhere for
genicular artery embolization.
Professor Mark Little, Consultant
Diagnostic & Interventional Radiologist, Radiology Research
Lead, at the University Department of Radiology at the Royal
Berkshire NHS Foundation Trust, is the Principal Investigator of
the GENESIS II study. "In GENESIS, our previous 38-patient
prospective study, GAE in patients with mild to moderate knee OA
was found to be safe and effective at early follow-up," said
Professor Little. "We're excited to build upon this foundation with
GENESIS II, which has the potential to improve our understanding of
the clinical applications for the procedure. Including a
sham-treated group provides the opportunity to validate the
findings of GENESIS as well as gain insight into longer term
follow-up and patient quality of life."
"Varian is committed to supporting research that has the
potential to improve outcomes and enhance the quality of life for
patients around the world, and we view the GENESIS II study as an
important opportunity to do this," said David Hahn, MD, Chief Medical Officer,
Interventional Solutions, at Varian. "Interventional radiology is
defined by minimally invasive techniques, and we believe the
treatment of chronic pain is a natural fit for this specialty,
particularly given the World Health Organization's guidance on this
subject. We look forward to better understanding the possible role
of GAE in addressing a pressing challenge for care providers and
patients."
About Genicular Artery
Embolization (GAE)
GAE is a minimally invasive procedure in which a small catheter
is advanced into the genicular arteries, the small blood vessels
that supply the knee joint and contribute to the inflammatory
process. Embolic microspheres are delivered through the catheter to
reduce the blood supply to the areas of greatest inflammation.
About Knee Osteoarthritis
(OA)
Osteoarthritis of the knee joint is a highly common,
debilitating condition, and a leading cause of chronic
disability.i Approximately 13% of women
and 10% of men aged 60 years and older have symptomatic knee
OA.ii In addition to treatment, affected
individuals and their families often must adapt their lives and
homes to the disease.iii The pain and
other symptoms of OA may have a profound effect on quality of life,
impacting both physical function and psychological wellbeing.
About Varian Interventional
Solutions
Varian, a Siemens Healthineers company, is investing in the
future of interventional radiology through our Interventional
Solutions group. By partnering with interventional
radiologists and researchers in the field, we are delivering a
portfolio of intelligent solutions to benefit patients around the
globe. We are committed to enhancing the patient experience at
every stage of care by developing and delivering innovative
solutions in ablation, embolization and beyond.
About Varian
At Varian, a Siemens Healthineers company, we envision a world
without fear of cancer. For more than 70 years, we have developed,
built and delivered innovative cancer care technologies and
solutions for our clinical partners around the globe to help them
treat millions of patients each year. With an Intelligent Cancer
Care approach, we are harnessing advanced technologies like
artificial intelligence, machine learning and data analytics to
enhance cancer treatment and expand access to care. Our 11,000
employees across 70 locations keep the patient and our clinical
partners at the center of our thinking as we power new victories in
cancer care. Because, for cancer patients everywhere, their fight
is our fight. For more information,
visit http://www.varian.com and
follow @VarianMedSys on Twitter.
Press Contact
Katie Villany
Varian Corporate Communications
Katie.villany@varian.com
i J. Bijlsma, F. Berenbaum and F. Lafeber.
"Osteoarthritis: an update with relevance for clinical
practice."
Lancet. Jun 2011:377(9783):2115–2126.
ii B. Heidari. "Knee osteoarthritis prevalence, risk
factors, pathogenesis and features: Part I." Caspian J Intern
Med. ,2011(2):205-12.
iii R. Altman, "Early management of osteoarthritis.,"
Am J Manag Care, March
2010(16):41-47.
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SOURCE Varian