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March 11, 2025
Instylla Completes FDA PMA Submission for Embrace Hydrogel Embolic System
March 11, 2025—Instylla, Inc. announced that it recently submitted the final module of its premarket approval (PMA) application to the FDA for the company’s Embrace hydrogel embolic system (HES).
According to Instylla, Embrace HES is an investigational device intended to embolize hypervascular tumors in vessels ≤ 5 mm. The company stated that the Embrace HES is composed of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during embolization.
The device’s main components are water and polyethylene glycol. Embolization with the device uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment, noted the company.
The final PMA module includes clinical study results that advance the company’s pursuit of an indication for the embolization of hypervascular tumors. Previously submitted modules have included preclinical testing, and manufacturing is completed, reported the company.
Embrace HES is limited by United States law to investigational use only and is not available for sale, advised Instylla.
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