Merit Medical Embosphere Microspheres Achieve CE Mark for Genicular Artery Embolisation to Treat Knee Osteoarthritis

Rhea-AI Summary

Merit Medical Systems (NASDAQ: MMSI) has received CE Mark approval for its Embosphere® Microspheres for use in genicular artery embolisation (GAE) to treat knee osteoarthritis in the European Union. This expanded indication targets a significant market, as osteoarthritis affects approximately 595 million people globally, with the knee being the most commonly affected joint.

Clinical data demonstrates that over 75% of patients treated with Embosphere for GAE achieved clinical success with significant pain reductions sustained through 24 months. The treatment showed superior results compared to corticosteroid injections, with greater improvements in pain and quality of life at 3 months. Embosphere has been used to treat more than 800,000 patients worldwide and has been studied in over 130 pivotal clinical articles over its 25-year history.

Positive

• Clinical success rate of over 75% in knee osteoarthritis treatment
• Sustained pain reduction results through 24 months
• Superior efficacy compared to corticosteroid injections
• Extensive clinical validation with over 130 pivotal studies
• Large established user base with 800,000+ patients treated worldwide

Negative

• None.

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

Learn more about Embosphere Microspheres.

“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. 

TRADEMARKS 
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. 

CONTACTS 

PR/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 

1. Institute for Health Metrics and Evaluation. 2023. “Global, Regional, and National Burden of Osteoarthritis, 1990–2020 and Projections to 2050.” Last modified August 21, 2023.

2. World Health Organization. 2023. “Osteoarthritis.” Last modified July 14, 2023.

3. Data on file.

FAQ

What is the new CE Mark approval for Merit Medical's Embosphere Microspheres (NASDAQ: MMSI)?

Merit Medical received CE Mark approval for Embosphere® Microspheres to be used in genicular artery embolisation (GAE) for treating knee osteoarthritis in the European Union.

What are the clinical success rates for Merit Medical's Embosphere in treating knee osteoarthritis?

Over 75% of patients achieved clinical success with significant pain reductions sustained through 24 months, and showed better improvements in pain and quality of life compared to corticosteroid injections at 3 months.

How many patients have been treated with Merit Medical's Embosphere Microspheres?

Embosphere has been used to treat more than 800,000 patients worldwide and has been studied in over 130 pivotal clinical articles during its 25-year history.

What is the market size for Merit Medical's new knee osteoarthritis treatment?

The treatment addresses a significant market of approximately 595 million people worldwide affected by osteoarthritis, with knee being the most frequently affected joint.

How does Merit Medical's Embosphere treatment work for knee osteoarthritis?

Embosphere is used in genicular artery embolisation (GAE), which selectively reduces blood flow to the inflamed synovium (joint lining), resulting in reduced knee pain and improved joint function and mobility.