Merit Medical Systems, Inc. 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 osteoarth arthritis.

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 osteoarth arthritis across medical centers in North America, Brazil, Europe, Australia, and New Zealand.

In conducting the study, Merit intends to randomized 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 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 thenee.