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Instylla Completes FDA PMA Submission for Embrace Hydrogel Embolic System - Endovascular Today

Summary by Endovascular Today
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 delive…
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Instylla Completes FDA PMA Submission for Embrace Hydrogel Embolic System - Endovascular Today

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 delive…

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Endovascular Today broke the news in on Tuesday, March 11, 2025.
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