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TISSIUM has received the CE Mark for Eclipsium, its solution for non-penetrating fixation of composite meshes to soft tissue in ventral hernia repair performed via a minimally invasive intraperitoneal approach, paving the way for its commercialization in Europe, with an initial release expected in 2027
The CE Mark follows completion of enrollment in the European ALPHA clinical study, which evaluated the safety & performance of Eclipsium in pts undergoing laparoscopic ventral hernia repair across multiple centers in Belgium & Spain & formed part of the clinical evidence supporting the submission; in the US, first pts have been treated in the randomized UNITE study under an FDA IDE
Eclipsium combines TISSIUM’s bioabsorbable, light-activated polymer with dedicated accessories to avoid tissue penetration by tacks or sutures; it is the company’s second polymer-based product to receive regulatory approval, following the US FDA De Novo authorization of COAPTIUM CONNECT for peripheral nerve repair in 2025
Ref: GlobeNewswire | Image: TISSIUM | Press Release
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The post TISSIUM Receives CE Mark for Eclipsium to Enable Atraumatic Mesh Fixation in Ventral Hernia Repair appeared first on PharmaShots.
TISSIUM Receives CE Mark for Eclipsium to Enable Atraumatic Mesh Fixation in Ventral Hernia Repair | PharmaVoice