Medical Device News

Positive Results from Preclinical Studies of Embrace Hydrogel Embolic System in Hemorrhage Models

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Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced two publications that evaluated the Embrace™ Hydrogel Embolic System (HES) in preclinical porcine hemorrhage models.

In a Journal of Vascular and Interventional Radiology (JVIR) publication, Dr. Gandras et al. evaluatedi the ability of Embrace HES to achieve hemostasis in a porcine mesenteric artery hemorrhage model that replicates injury in humans. Results demonstrated that Embrace HES achieved complete, rapid, and durable embolization in 100% of the injured arteries with a mean delivery time of 5.3 minutes. There was no angiographic evidence of non-target embolization.

“Embrace was effective in achieving hemostasis in an animal hemorrhage model without evidence of non-target embolization. This next generation liquid embolic has tremendous potential to play an important therapeutic role in a wide variety of clinical applications including hemorrhage and interventional oncology,” commented Dr. Eric Gandras, Associate Chief, Vascular and Interventional Radiology at North Shore University Hospital, New York, and lead author of the study.

In an independent studyii conducted by Dr. Kauvar et al., splenic injury and resulting hemorrhage were induced in swine models. A comparison was made between a control group having no embolic treatment to treatment groups that received embolization with Embrace HES, gel foam slurry, or coils. Under coagulopathic conditions, Embrace HES showed improved survival time and a significant reduction in bleeding compared to the control group, gel foam slurry, and coil treatments.
About Embrace Hydrogel Embolic System:

Embrace HES is an investigational device intended to be used to embolize peripheral arterial bleeds in vessels ≤ 6 mm. Embrace HES consists of two liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during the embolization procedure. The Embrace HES embolization uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG).

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