Новое средство для лечения артроза колена показало высокую эффективность и безопасность в клиническом исследовании

В проспективном исследовании 194 пациента с остеоартрозом колена, не ответивших на консервативное лечение, применение эмболического агента Nexsphere-F™ привело к снижению боли на 57% и улучшению функции сустава у 80% участников. Производитель NEXTBIOMEDICAL планирует использовать эти данные для расширения присутствия на европейском рынке и получения одобрения FDA в США.

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The prospective study enrolled 194 patients with knee osteoarthritis who had not responded to conventional conservative treatments, including corticosteroid and hyaluronic acid injections, and evaluated the safety and clinical outcomes of GAE performed with Nexsphere-F™. Prospective studies, which follow patients according to a predetermined protocol, are widely regarded as providing a higher level of clinical evidence than retrospective analyses. Across 239 procedures, GAE using Nexsphere-F™ achieved a 100% technical success rate. Patients' pain scores, measured on the Numeric Rating Scale, decreased from a median of 7 before the procedure to 3 at 12 months post-procedure, a 57% reduction. Knee function and quality of life, assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), improved significantly across all measures, with approximately 80% of patients achieving a minimum clinically important difference (MCID). No moderate or severe procedure-related adverse events were reported. NEXTBIOMEDICAL expects the results to support its expansion into the European market, where Nexsphere-F™ holds CE marking under the Medical Device Directive (CE-MDD). The clinical data is also expected to serve as key evidence for future efforts to expand insurance reimbursement and adoption among medical institutions. In the United States, the RESORB clinical trial to support FDA approval is currently underway and progressing smoothly. The study's authors described Nexsphere-F™ as a novel embolic agent that offers a favorable balance of safety and efficacy relative to permanent microspheres and imipenem-cilastatin (IPM-CS). Permanent microspheres and IPM-CS have been associated with skin discoloration rates as high as 65% and 18%, respectively, in prior studies, with skin ulceration reported in one such study involving permanent particles. By contrast, Nexsphere-F™ was associated with transient skin discoloration in just 6.3% of procedures, resolving within 24 hours. A representative from NEXTBIOMEDICAL stated that publication in Radiology reflects strong international recognition of Nexsphere-F™'s clinical value and differentiation. The representative added that through the ongoing RESORB clinical trial in the United States, NEXTBIOMEDICAL plans to continue building the clinical evidence needed to help establish Nexsphere-F™ as a global standard of care in genicular artery embolization.