Merit Medical Embosphere Microspheres Achieve CE Mark for Genicular Artery Embolisation to Treat Knee Osteoarthritis
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.
Merit Medical Systems (NASDAQ: MMSI) ha ottenuto l'approvazione CE per i suoi Embosphere? Microspheres per l'uso nell'embolizzazione dell'arteria genicolare (GAE) per trattare l'osteoartrosi del ginocchio nell'Unione Europea. Questa indicazione ampliata punta a un mercato significativo, poiché l'osteoartrosi colpisce circa 595 milioni di persone in tutto il mondo, con il ginocchio che è l'articolazione più comunemente interessata.
I dati clinici dimostrano che oltre il 75% dei pazienti trattati con Embosphere per GAE ha ottenuto successo clinico con riduzioni significative del dolore sostenute per 24 mesi. Il trattamento ha mostrato risultati superiori rispetto alle iniezioni di corticosteroidi, con miglioramenti maggiori nel dolore e nella qualità della vita a 3 mesi. Embosphere è stato utilizzato per trattare più di 800.000 pazienti in tutto il mondo ed è stato studiato in oltre 130 articoli clinici pivotal nel corso dei suoi 25 anni di storia.
Merit Medical Systems (NASDAQ: MMSI) ha obtenido la aprobación CE para sus EmSphere? Microspheres para su uso en la embolización de la arteria genicular (GAE) para tratar la osteoartritis de rodilla en la Unión Europea. Esta indicación ampliada apunta a un mercado significativo, ya que la osteoartritis afecta a aproximadamente 595 millones de personas en todo el mundo, siendo la rodilla la articulación más afectada.
Los datos clínicos demuestran que más del 75% de los pacientes tratados con Embosphere para GAE lograron éxito clínico con reducciones sustanciales del dolor mantenidas durante 24 meses. El tratamiento mostró resultados superiores frente a las inyecciones de corticosteroides, con mejoras mayores en dolor y calidad de vida a los 3 meses. Embosphere se ha utilizado para tratar más de 800,000 pacientes en todo el mundo y ha sido estudiado en más de 130 artículos clínicos clave a lo largo de sus 25 a?os de historia.
Merit Medical Systems (NASDAQ: MMSI)? ?? ???? ?? ???? ??? ?? Embosphere? Microspheres? ??? ?? CE ?? ??? ?????. ? ??? ??? ???? ? ??? ????, ????? ? ????? ? 5? 9500? ?? ??? ???, ??? ?? ??? ??? ?? ?????.
?? ???? ??? ??? ?? ??? 75% ??? GAE? ??? ??? ????, ?? ??? 24?? ?? ???????. ? ??? ????????? ??? ?? ??? ??? ????, 3?? ???? ??? ?? ?? ??? ? ?? ??????. Embosphere? ? ????? 80? ?? ?? ??? ???? ? ?????, 25?? ?? ?? 130? ??? ??? ?? ???? ???????.
Merit Medical Systems (NASDAQ : MMSI) a re?u l'approbation CE pour ses Embosphere? Microspheres en vue de leur utilisation dans l'embolisation de l'artère geniculaire (GAE) pour traiter l'ostéoarthrite du genou dans l'Union européenne. Cette indication élargie vise un marché important, car l'ostéoarthrite touche environ 595 millions de personnes dans le monde, le genou étant l'articulation la plus fréquemment touchée.
Les données cliniques montrent que plus de 75 % des patients traités avec Embosphere pour GAE ont atteint un succès clinique avec des réductions significatives de la douleur soutenues pendant 24 mois. Le traitement a montré des résultats supérieurs par rapport aux injections de corticostéro?des, avec des améliorations plus importantes de la douleur et de la qualité de vie à 3 mois. Embosphere a été utilisé pour traiter plus de 800 000 patients dans le monde et a été étudié dans plus de 130 articles cliniques pivot au cours de ses 25 ans d'histoire.
Merit Medical Systems (NASDAQ: MMSI) hat die CE-Kennzeichnung für seine Embosphere? Microspheres zur Verwendung bei der Embolisation der Geniculararterie (GAE) zur Behandlung der Kniearthrose in der Europ?ischen Union erhalten. Diese erweiterte Indikation zielt auf einen bedeutenden Markt ab, da die Osteoarthritis weltweit etwa 595 Millionen Menschen betrifft und das Knie das am h?ufigsten betroffene Gelenk ist.
Klinische Daten zeigen, dass über 75 % der Patienten, die Embosphere für GAE erhalten, einen klinischen Erfolg mit signifikanten Schmerzreduktionen über 24 Monate erreichen. Die Behandlung zeigte bessere Ergebnisse im Vergleich zu Kortikosteroid-Injektionen, mit gr??eren Verbesserungen bei Schmerz und Lebensqualit?t nach 3 Monaten. Embosphere wird zur Behandlung von mehr als 800.000 Patienten weltweit eingesetzt und wurde in über 130 wichtigen klinischen Artikeln in der 25-j?hrigen Geschichte untersucht.
Merit Medical Systems (NASDAQ: MMSI) ?? ???? ??? ?????? CE ?? ?????? Embosphere? Microspheres ????????? ?? ?????? ??????? ???????? ??????? (GAE) ????? ????? ?????? ??????? ?? ??????? ????????. ??? ??????? ?????? ?????? ????? ?????? ?? ???? ????? ?????? ??? ??? 595 ????? ??? ??? ??????? ??? ?????? ?? ?????? ?????? ??????.
???? ???????? ???????? ??? ?? ???? ?? 75% ?? ?????? ????? ?????? ?? Embosphere ?? GAE ????? ?????? ????? ?? ???????? ????? ?? ????? ????? ??? 24 ?????. ???? ?????? ????? ?????? ?????? ???? ????????????????? ?? ??????? ???? ?? ????? ?????? ?????? ??? 3 ????. ?????? Embosphere ????? ???? ?? 800,000 ???? ??? ?????? ??? ?????? ?? ???? ?? 130 ?????? ??????? ?????? ???? ?????? ???? ???? 25 ?????.
Merit Medical Systems (NASDAQ: MMSI) 已获得其 Embosphere? Microspheres 的 CE 认证，可用于欧洲联盟内的股骨动脉栓塞（GAE）治疗膝关节骨关节炎。此次扩展适应症瞄准一个重要市场，因为全球约有 5.95 亿人受骨关节炎影响，膝关节是最常受影响的关节。
临床数据显示，超过 75% 的患者在接受 Embosphere 进行 GAE 治疗后实现了临床成功，痛感显著下降且在 24 个月内持续。该治疗相较于糖皮质激素注射显示出更优的结果，在 3 个月时在疼痛和生活质量方面有更大改进。Embosphere 已用于治疗全球 超过 80 万名患者，在其 25 年历史中被用于超过 130 篇关键临床文章的研究。
- 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
- None.
Insights
Merit Medical's CE Mark for Embosphere in knee osteoarthritis treatment expands their addressable market substantially with proven technology.
Merit Medical has secured a significant regulatory milestone with the CE Mark approval for Embosphere Microspheres to treat knee osteoarthritis through genicular artery embolisation (GAE) in the European Union. This approval strategically positions the company in the massive osteoarthritis market that affects approximately
The expanded indication leverages Merit's already established Embosphere technology, which has 25+ years of clinical use and has treated over 800,000 patients worldwide. This represents efficient product lifecycle management by extending an existing technology into new therapeutic areas rather than developing entirely new products.
Clinical data supporting this approval is compelling, showing that
The market opportunity is substantial and growing due to aging populations, increasing obesity rates, and sports injuries. GAE represents a minimally invasive alternative that could delay or potentially eliminate the need for surgical interventions like knee replacements, positioning Merit to capture value in the continuum of care for osteoarthritis patients.
From a competitive standpoint, Merit's emphasis on Embosphere's tighter calibration compared to competing devices suggests they're highlighting technical differentiation in a procedure where precision is critical when treating small genicular arteries. This expanded indication builds upon Embosphere's established uses in treating uterine fibroids, arteriovenous malformations, and benign prostatic hyperplasia.
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
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.?
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?
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Merit Medical?
+1-801-432-2864 |??
Investor Inquiries?
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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.
FAQ
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