Instylla announced today that it received FDA premarket approval (PMA) for its flagship Embrace hydrogel embolic system (HES).
The Bedford, Massachusetts-based company received approval for Embrace for the embolization of hypervascular tumors (HVTs) in peripheral arteries ≤ 5mm. HVTs commonly occur in the liver, kidney, bone and other organs, characterized by an abnormal increase in blood vessels. They have poor survival outcomes and high vascularity can make surgical removal difficult due to elevated bleeding risks.
Embrace HES features two low-viscosity aqueous liquid precursors. These interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolization procedure. They form a soft, polyethylene glycol (PEG) hydrogel. This liquid embolic deeply penetrates the tumor’s vascular bed, crosslinks and stops blood flow.
Instylla picked up PMA based on a study demonstrating Embrace’s safety and effectiveness compared to the standard of care. The randomized study evaluated 150 patients with hypervascular tumors across 22 global institutions. Embrace met both primary safety and efficacy endpoints and led to zero adverse events classified as device-related only.
Approval for Embrace follows FDA clearance at the beginning of this year for the Tembo Embolic System. Tembo, a bioresorbable embolization agent, offers embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.
“We are incredibly proud to receive FDA approval for Embrace HES, offering a transformational embolic platform technology solving critical unmet needs for cancer patients with hypervascular tumors,” said Sean Boyle, CEO, Instylla. “We are motivated and committed to delivering technically advanced, clinically impactful solutions that empower interventional radiologists and expand therapeutic options across a broad range of vascular conditions.”
