Merit Medical Commences MOTION Study of Embosphere Microspheres for GAE

January 16, 2024—Merit Medical Systems, Inc. announced the enrollment of the first patient in the multicenter, prospective MOTION randomized controlled trial.

The study is comparing genicular artery embolization (GAE) using the company’s Embosphere microspheres versus corticosteroid injections for the treatment of symptomatic knee osteoarthritis.

According to the company, the minimally invasive GAE procedure selectively reduces blood flow to areas of the knee where hypervascularity has been identified, helping to alleviate pain and inflammation associated with knee osteoarthritis.

Merit stated that 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. Patients will be randomized 1:1 to receive either GAE using Embosphere microspheres or intra-articular corticosteroid injections.

The study will evaluate the primary safety and effectiveness of Embosphere microspheres at 6 months, with continued patient follow-up through 24 months.

Sandeep Bagla, MD, and Craig J. McAsey, MD, are coglobal Principal Investigators of MOTION.

“The commencement of this randomized controlled study is a testament to our commitment to evidence-based medicine and patient-centric care,” commented Dr. Bagla in Merit’s press release. “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.”

Dr. McAsey added, “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. 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.”

Merit advised that MOTION is an investigational device exemption study of Embosphere microspheres, which are not currently approved in any country as an embolic agent for knee osteoarthritis.

In 2022, Merit announced that the FDA granted Breakthrough Device designation for Embospheres 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.