Merit Medical Embosphere Microspheres Achieve CE Mark for Genicular Artery Embolisation to Treat Knee Osteoarthritis
Expanded indication provides patients with knee osteoarthritis the benefits of Embosphere’s consistent, predictable, and effective clinical results.
SOUTH JORDAN, Utah, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced that Embosphere® Microspheres are now indicated in the European Union for use in genicular artery embolisation (GAE) to treat patients with knee osteoarthritis (OA).
The most common type of arthritis, OA affects about 595 million people worldwide;1 with the knee being the most frequently affected joint.2 Ageing populations, as well as increasing rates of injury and obesity, contribute to this number, and prevalence is expected to increase.2
Performed by an interventional radiologist, GAE selectively reduces blood flow to the inflamed synovium (thin lining within the joint), offering meaningful reductions in knee pain, improved joint function and mobility, and the potential to delay or avoid surgical intervention. GAE represents a growing area within musculoskeletal embolisation and is part of a broader trend toward minimally invasive, image-guided pain management therapies.
“OA can be very debilitating, impacting patient quality of life,” said Professor Mark Little, BSc (hons), MSc (Distinction), MBBS (Distinction), DipIPEM, FHEA, FRCR, Principal Investigator of the GENESIS study sponsored by Merit and Consultant Interventional Radiologist and Director of Radiology Research at the Royal Berkshire NHS Foundation Trust in Reading, United Kingdom. “GAE is a non-surgical option that provides fast and lasting pain relief in patients with mild to moderate OA. CE Mark of Embosphere for GAE presents an exciting opportunity to advance this treatment option and further interventionalists’ ability to offer the positive results they expect from the procedure.”
Data show that over 75% of patients treated with Embosphere for GAE achieved clinical success with significant reductions in knee pain sustained through 24 months.3 In addition to durable pain relief over time, Embosphere was associated with a decrease in pain-medication use and improvements in quality-of-life measures.3 Compared to corticosteroid injections, GAE with Embosphere achieved consistently higher clinical success, with greater improvements at 3 months in pain and quality of life.3
Made from a proprietary formulation of a tris-acrylic cross-linked co-polymer, Embosphere’s spherical shape provides complete and durable occlusion of targeted blood vessels.3 Tighter calibration than competitive devices provide consistent and reliable performance,3 which is important when treating small genicular arteries.
A proven embolotherapy solution for more than 25 years, Embosphere has been extensively studied in over 130 pivotal clinical articles and has been used to treat more than 800,000 patients worldwide. 3 Embosphere has shown long-term performance treating uterine fibroids, arteriovenous malformations (AVM), and benign prostatic hyperplasia (BPH).3
“This expanded indication underscores our commitment to continued innovation that supports the minimally invasive therapies our healthcare partners provide,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “In the case of Embosphere, a long-standing leader in the embolic space, it remains a trusted solution that’s use has grown in ways that have positively impacted patient lives and will pave the way for embolotherapy well into the future.”
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 more than 800 individuals. Merit employs approximately 7,300 people worldwide.
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1. Institute for Health Metrics and Evaluation. 2023. “.” Last modified August 21, 2023.
2. World Health Organization. 2023. “.” Last modified July 14, 2023.
3. Data on file.
