Embolization Treatment
Transcatheter embolization is a minimally invasive technique where catheter-directed embolic agents are delivered to stop blood vessels that are injured or bleeding or close off vessels supplying blood to a tumor.
While less invasive than open surgery, existing embolization treatments involve shortcomings requiring active management by interventional radiologists. These include:
- Failure to deeply and comprehensively penetrate the tumor vascular bed allowing for continued tumor blood flow
- Inadvertent delivery into healthy vessels leading to non-target embolization and healthy tissue injury
- Dependence on blood coagulation to complete embolization, potentially delaying occlusion in patients with compromised blood clotting
- Inefficient embolic preparations
- Procedural complexity from compromised visibility and nuanced, time-dependent applications that require rigorous training and expertise
Water-based PEG Hydrogel Technology
Embrace™ Hydrogel Embolic System (HES) consists of two low viscosity liquid precursors that polymerize intravascularly when simultaneously injected into blood vessels forming a soft, water-based PEG hydrogel, during the embolization procedure.
Before use, the precursors are mixed with commercially available iodinated contrast media enabling radiopacity. The hydrogel contains no organic solvents in its formulation. Upon delivery, the hydrogel casts out the vasculature to potentially create a rapid and durable occlusion. The hydrogel liquifies via hydrolysis over a period of approximately 6 months, and the hydrolysis products are absorbed and cleared via renal filtration.1
Hydrogel Embolic System
Embrace Hydrogel Embolic System (HES) is a minimally-invasive, vascular embolization treatment that interventional radiologists can potentially easily deliver with immediate, complete, and persistent embolization.2
Potential Advantages
Complete and Persistent Occlusion
Predictable and Effective Embolic
Easy and Accurate Delivery
Embrace HES Clinical Applications
Embrace HES is an investigational device designed to be used in different embolization applications.
With its ability to potentially achieve deep, distal penetration, with less recanalization, Embrace HES can be used to treat hypervascular tumors.
Embrace hydrogel can also be used to embolize solid organ trauma or GI arterial bleeds3 with its potential to rapidly occlude vessels independent of the patient’s coagulation status4, potentially resulting in immediate, complete, and durable hemostasis.
Effective at Embolizing Hypervascular Tumors
As demonstrated in the First-in-Human (FIH) study, Embrace HES was effective at embolizing malignant and benign hypervascular tumors by blocking tumor blood supply with technical success in all patients and persistent embolization as noted in imaging follow up at 30-days.5
1Data on file at Instylla.
2Ganguli, S., et al., A Water-Based Liquid Embolic: Evaluation of its Safety and Efficacy in a Rabbit Kidney Model. Journal of Vascular and Interventional Radiology, 2021. 32(6): p. 813-818.
3Gandras, E.J., T. Jarrett, and R. Lareau, Evaluation of a Hydrogel Liquid Embolic Agent in a Porcine Mesenteric Hemorrhage Model. J Vasc Interv Radiol, 2022. 33(6): p. 653-659.
4Kauvar DS, Polykratis IA, De Guzman R, Prince MD, Voelker A, Kheirabadi BS, Dubick MA. Evaluation of a novel hydrogel intravascular embolization agent in a swine model of fatal uncontrolled solid organ hemorrhage and coagulopathy. JVS Vasc Sci. 2021 Mar 3;2:43-51.
5Goh, G.S., et al., A Pilot First-in-Human Study of Embrace, a Polyethylene Glycol-Based Liquid Embolic Agent, in the Embolization of Malignant and Benign Hypervascular Tumors. Journal of Vascular and Interventional Radiology, 2022. 33(6): p. 660-667.
Instylla Delivery Kit
The Instylla Delivery Kit Instructions for Use (IFU) only for the EU are available for download below.