Hydrogel Embolic System Non-Inferior to SOC for Hypervascular Tumor Embolization

In a randomized trial, the Instylla Embrace Hydrogel Embolic System (HES) achieved 99% freedom from major adverse events and 88.6% technical success vs. 77.9% for standard embolics (p=0.001) in hypervascular tumors.

• Prospective, multicenter, randomized (2:1), non-inferiority study in 150 adults (mean age 65) with malignant and benign tumors ≤8 cm.
• Technical success, the effectiveness endpoint, was independently adjudicated by a blinded imaging core lab; HES success 88.6% vs SOC 77.9% (p=0.001).
• Key limitation: Technical success defined as stasis of flow; clinical outcomes and long-term efficacy beyond 180 days are not yet fully characterized.

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