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

Key Takeaway: Merit Medical Systems has announced that its Embosphere Microspheres have received CE Mark approval for use in genicular artery embolisation (GAE) to treat knee osteoarthritis in the EU. This non-surgical procedure aims to reduce blood flow to the inflamed joint, providing significant pain relief and improved mobility. Clinical data indicates that over 75% of patients experienced sustained pain reduction for up to 24 months. The approval highlights the growing trend towards minimally invasive therapies in pain management.

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POSITIVE FACTORS

  • Embosphere Microspheres received CE Mark for treating knee osteoarthritis.
  • Over 75% of patients reported significant pain reduction after treatment.
  • GAE offers a non-surgical option for knee pain relief.
  • The product has a long history of successful use in various medical conditions.

Full Press Release Details

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;1with the knee being the most frequently affected joint.2Ageing 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.3In addition to durable pain relief over time, Embosphere was associated with a decrease in pain-medication use and improvements in quality-of-life measures.3Compared 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.3Tighter calibration than competitive devices provide consistent and reliable performance,3which 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.3Embosphere 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 MEDICALFounded 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.
TRADEMARKSUnless 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 InquiriesSarah Comstock
Merit Medical+1-801-432-2864 |sarah.comstock@merit.com
Investor InquiriesMike 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.

Frequently Asked Questions

What is the purpose of Embosphere Microspheres?

Embosphere Microspheres are used in genicular artery embolisation to treat knee osteoarthritis.

How effective is GAE with Embosphere?

Over 75% of patients treated with Embosphere reported significant pain relief sustained for 24 months.

What are the benefits of GAE for knee OA?

GAE provides fast, lasting pain relief and improves joint function without surgery.

Who performed the GAE procedure?

The GAE procedure is performed by an interventional radiologist.

Last updated: Sep 12, 2025