Instylla Submits PMA Application for Embrace HES Hydrogel Embolic Agent
Instylla
Hydrogel Embolization System Provider
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Transcatheter Arterial Chemoembolization (TACE) is an interventional treatment technique that combines local chemotherapy and vascular embolization for the treatment of liver tumors. Chemotherapy drugs are directly injected into the tumor's blood supply artery through a catheter, followed by vessel embolization to achieve dual effects.
Compared with traditional surgical operations, TACE has less trauma and faster recovery, but it still has shortcomings. The main limitations include: the embolization of complex tumor vascular networks is often not thorough enough, which can easily leave residual tiny blood-supplying branches; embolic materials may accidentally enter normal blood vessels, causing non-target embolization and related complications; the surgical outcome is affected by the patient's coagulation function—those with abnormal coagulation may experience incomplete or delayed embolization. In addition, due to the limitations of intraoperative image guidance and the high demand for the operator’s experience and technical skills, the promotion of this technology is somewhat restricted.
Instylla Develops New Liquid Embolic Agent Embrace HES. Embrace HES embolization requires no solvent, no adjustment based on vessel diameter, and does not cause catheter entrapment, allowing for complete filling of the target vessel, including distal small vessels. Instylla also announced that it has submitted the Embrace HES PMA application to the FDA. This means the new hydrogel vascular embolic agent Embrace HES is expected to be launched next year, providing a new treatment option for patients with highly vascularized tumors.
Embrace HES Hydrogel Embolic Agent
Embrace HES is an embolic agent capable of occluding vessels ≤5 mm in diameter, consisting of a hydrogel precursor and a delivery system. The hydrogel precursor primarily comprises PEG (polyethylene glycol), an initiator, and water, with the PEG solvent and initiator solvent stored separately in two syringes. The delivery system consists of two coaxial microcatheters, with the outer catheter having an inner diameter ≥0.027 inches, and the inner catheter having an inner diameter of 1.2Fr and an outer diameter of 1.7Fr. The hydrogel precursor is delivered to the target vessel through a specialized microcatheter. When the two solutions mix within the vessel, the initiator triggers the polymerization of PEG, forming a highly cross-linked, soft hydrogel that completely fills the pre-embolized vessel.
Compared with traditional embolic agents, Embrace HES has several advantages:
Perfect Fill: Not limited by vascular anatomy, it can perfectly fill the entire vessel that needs embolization, including the distal small vessels.
Biodegradability: Hydrogels are biodegradable in the body, reducing foreign body reactions in patients.
High Safety: Reduces the risk of ectopic embolization and enhances the safety and efficacy of the treatment.
Not affected by coagulation status: Hydrogels can also be used for embolization of solid organ trauma or gastrointestinal arterial bleeding, with the potential for rapid vascular occlusion regardless of the patient's coagulation status, leading to immediate and lasting hemostasis.
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Review and Compilation: Chen Xi, Associate Chief Physician, Wuhan First Hospital
Editor: Vascular Information Oliver
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