First Patient Enrolled in Merit Medical’s MOTION Study
16 Enero 2024 - 3:05PM
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global
manufacturer and marketer of healthcare technology, today announced
the successful enrollment of the first patient in its multicenter,
prospective, randomized, controlled trial comparing genicular
artery embolization (GAE) using Embosphere® Microspheres to
corticosteroid injections for the treatment of symptomatic knee
osteoarthritis (MOTION) study.
Globally, more than 650 million adults are affected by
osteoarthritis of the knee.1 Injections of corticosteroids
(intra-articular injections) are commonly used to relieve pain
associated with knee osteoarthritis. However, the long-term benefit
of intra-articular injections is limited. Hypervascularity
(increased blood vessels) and inflammatory processes are key
contributors to the development and progression of knee
osteoarthritis. GAE is a minimally invasive procedure that
selectively reduces blood flow to areas of the knee where
hypervascularity has been identified, helping to alleviate pain and
inflammation associated with knee osteoarthritis.
In 2022, the United States Food and Drug Administration (FDA)
granted Merit’s Embosphere Microspheres “breakthrough device
designation” for GAE. Under this designation, Embosphere
Microspheres received priority review by the FDA, which allowed for
accelerated review and development of the MOTION study
protocol.
The MOTION study is designed to enroll up to 264 adults with
symptomatic knee osteoarthritis across medical centers in North
America, Brazil, Europe, Australia, and New Zealand. In conducting
the study, Merit intends to randomize patients 1:1 to receive
either GAE using Embosphere Microspheres or intra-articular
corticosteroid injections. The study is structured to evaluate
primary safety and effectiveness of Embosphere Microspheres at 6
months with continued patient follow up through 24 months.
“The commencement of this randomized controlled study is a
testament to our commitment to evidence-based medicine and
patient-centric care,” said Sandeep Bagla, MD, Co-Global Principal
Investigator of the MOTION study. “Through rigorous research and
collaboration with leading experts, we aim to establish Embosphere
Microspheres as a game-changing treatment option, setting a new
standard in knee-pain management.”
“We look forward to the results of this study, as we feel it can
offer another solution to the millions of people globally who
suffer from arthritic knee pain every year,” said Craig J. McAsey,
MD, Co-Global Principal Investigator of the MOTION study, and paid
consultant of Merit. “In orthopedics, we are still searching for an
effective alternative to surgery when possible; I am hopeful that
this will actually bring us closer to that goal.”
“We are proud of our strong legacy as a market leader of
embolotherapies, such as Embosphere Microspheres, that have
meaningfully improved patients’ quality of life,” said Fred
Lampropoulos, Merit’s Chairman and CEO. “We anticipate that the
results from the MOTION study will allow us to expand the clinical
benefits of Embosphere Microspheres to help clinicians safely and
effectively treat patients with symptomatic knee
osteoarthritis.”
The MOTION study is an Investigational Device Exemption (IDE)
study; Embosphere Microspheres are not currently approved in any
country as an embolic agent for osteoarthritis of the knee.
For additional information on the MOTION study, including
ongoing updates, please visit:
https://clinicaltrials.gov/study/NCT05818150
Reference1Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global,
regional prevalence, incidence and risk factors of knee
osteoarthritis in population-based studies. EClinicalMedicine.
2020;29-30:100587.
ABOUT MERIT MEDICAL
Founded in 1987, Merit Medical Systems, Inc. is
engaged in the development, manufacture, and distribution of
proprietary disposable medical devices used in interventional,
diagnostic, and therapeutic procedures, particularly in cardiology,
radiology, oncology, critical care, and endoscopy. Merit serves
client hospitals worldwide with a domestic and international sales
force and clinical support team totaling in excess of 700
individuals. Merit employs approximately 7,100 people
worldwide.
TRADEMARKSUnless noted otherwise, trademarks and
registered trademarks used in this release are the property of
Merit Medical Systems, Inc., its subsidiaries, or its
licensors.
CONTACTSPR/Media Inquiries Sarah Comstock Merit
Medical +1-801-432-2864 | sarah.comstock@merit.com
Investor Inquiries Mike Piccinino, CFA, IRC
Westwicke - ICR +1-443-213-0509 |
mike.piccinino@westwicke.com
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