FDA Approves PEG Hydrogel Embolic System for Hypervascular Tumors

FDA Approves PEG Hydrogel Embolic System for Hypervascular Tumors

The FDA approves the Embrace Hydrogel Embolic System, offering a groundbreaking treatment for hypervascular tumors in interventional oncology.

Instylla’s Embrace Hydrogel Embolic System Approved by FDA - Endovascular Today

August 7, 2025—Instylla, Inc. announced premarket approval (PMA) from the FDA for the company’s flagship Embrace hydrogel embolic system. The device has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5 mm. According to the company, Embrace HES consists of two low-viscosity aqueous liquid precursors that interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolizati…

Instylla’s Embrace HES gains US FDA premarket approval - Interventional News

Embrace Hydrogel Embolic System Instylla has announced premarket approval (PMA) from the US Food and Drug Administration (FDA) for the company’s flagship product Embrace Hydrogel Embolic System (HES). Embrace HES has been approved for the embolization of hypervascular tumours in peripheral arteries ≤5mm. Hypervascular tumors (HVTs), which commonly occur in the liver, kidney, bone, and other organs, are characterised by an abnormal increase in bl…