Clinical Need
Embolization Treatment
Transcatheter embolization is a minimally invasive technique where catheter-directed embolic agents are delivered to 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 penetrate the tumor vascular bed allowing for continued tumor blood flow
- Flow into healthy vessels leading to non-target embolization and healthy tissue injury
- Inefficient embolic preparations
- Procedural complexity from compromised visibility and nuanced, time-dependent applications that require rigorous training and expertise
Solution
Embrace™ Hydrogel Embolic System
Embrace Hydrogel Embolic System (HES) is a minimally-invasive, vascular embolization treatment that interventional radiologists can easily deliver with immediate, targeted, and persistent embolization.¹
Embrace HES advantages:
- Efficient and Accurate Delivery
- Predictable and Effective Embolic
- Targeted and Sustained Occlusion
How it Works
Embrace™ HES Procedure
Embrace HES consists of two low-viscosity liquid precursors that interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolization procedure to form a soft, polyethylene glycol (PEG) hydrogel.
Before use, the precursors are mixed with commercially available iodinated contrast media, enabling radiopacity. This hydrogel formulation does not contain DMSO. Upon delivery, the hydrogel casts out the vasculature to create a rapid and sustained occlusion. The hydrogel liquifies via hydrolysis over approximately 11 months, and the hydrolysis products are absorbed and cleared via renal filtration.²
Embrace HES utilizes the Instylla™ Delivery Kit and Instylla™ Microcatheter for the embolization procedure.
The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip. The components are assembled together to enable the simultaneous delivery of the two Embrace Hydrogel Embolic System precursors.
The Instylla Microcatheter is a single-lumen catheter featuring a radiopaque marker at the tip to facilitate fluoroscopic visualization. It is advanced through a commercially available microcatheter and attaches to it via a 4Fr Tuohy-Borst side-port adapter.
The Instylla Microcatheter is available in 2 different sizes, 1.7 Fr and 1.2 Fr. Each size is offered in 2 lengths of 142 cm and 162 cm, making them suitable for a variety of different interventional radiology procedures.
The Embrace HES kit provides the solutions and accessories needed to prepare the two precursors.
Technical Specifications
| Attribute | Specification |
|---|---|
| Product Composition | Water and Polyethylene Glycol (PEG) |
| Depth of Penetration | Capillary level |
| Gel Time | < 2 seconds |
| Embrace HES Kit Volume | 7.5 mL |
| Microcatheter Compatibility |
|
| Absorption Time | ~11 months |
| Maximum Vessel Size | 5 mm |
Product Resources
Indications for Use:
The Embrace HES is indicated for embolization of hypervascular tumors in peripheral arteries ≤ 5mm.
Contraindications:
• Embolization procedures should not be performed if: ⦿ Patient is intolerant to occlusion procedures ⦿ Vascular anatomy or blood flow precludes correct catheter placement or embolic injection ⦿ Presence or likely onset of unresolvable vasospasm ⦿ Known or suspected conditions that would prevent successful catheterization of targeted vasculature ⦿ Presence of bilioenteric anastomoses or prior biliary interventions with stenting ⦿ Presence of collateral vessel pathways which could potentially endanger non-target tissue ⦿ Vascular resistance proximal to the feeding arteries precluding passage of Embrace HES into the lesion ⦿ In large-diameter arteriovenous shunts (i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein) in the pulmonary vasculature ⦿ Any neurovasculature or coronary location ⦿ Known allergies to polyethylene glycol (PEG), ferrous compounds, tert-Butyl Hydroperoxide that are not amenable to premedication.
The safety and effectiveness of Embrace HES in pediatric patients and pregnant women has not been established.
Warnings:
• Embolization with Embrace HES should be carried out under the direction of personnel with interventional training and thorough knowledge of angiographic techniques. • Pay careful attention for signs of mistargeted embolization. During injection carefully monitor patient vital signs. Consider terminating the procedure if any signs of mistargeting occur or patient symptoms develop. • Embrace HES may not polymerize in clinical conditions with high flow, shunting, and/or reflux leading to increased exposure to Embrace HES precursor solutions. • Tert-butyl hydroperoxide (TBHP), a component of the precursor solution, elicits genotoxicity and sensitization in animals. Biocompatibility of the unpolymerized precursor solutions has not been established. • Embolization should not be performed if Embrace HES cannot be safely delivered in conditions of high flow, shunting, and/or reflux. • Serious radiation-induced skin injury may occur to the patient due to long periods of fluoroscopic exposure, large patient diameter, angled x-ray projections, and multiple image recording runs or radiographs. Refer to your facility’s clinical protocol to ensure the proper radiation dose is applied for each specific type of procedure performed. Physicians should monitor patients who may be at risk. • Safety of Embrace HES at injected volumes greater than 7.5 mL into the patient has not been evaluated. Total volume of Embrace HES injected should not exceed 7.5 mL.
Precautions:
• Patients with known allergy to contrast media may need to be premedicated prior to embolization. • Additional evaluations or precautions may be necessary in managing periprocedural care for patients with the following conditions: ⦿ Bleeding diathesis or hypercoagulative state ⦿ Immunocompromised. • Do not use if any of the contents of the Embrace HES or package appear broken or damaged. Prior to use, carefully examine the unit to verify that the sterile package has not been damaged. If the sterile packaging has been damaged, or unintentionally opened prior to use, discard the unit. • For single-use only, do not resterilize. Attempts to reuse or resterilize this device may compromise the structural integrity of the device and/or lead to device failure, which in turn may result in patient injury, illness, or death. Reusing, reprocessing, or resterilizing may also create a risk of contamination of the device and/or cause patient infection or cross infection including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death. • Dispose of the used device or any unused material safely, following your institution’s local procedure for the disposal of medical waste. • All procedures must be performed according to accepted aseptic technique. • Exercise care in handling the microcatheter during a procedure to reduce the possibility of accidental breakage, bending, or kinking. • Excessive tightening of a hemostatic valve (such as the Tuohy-Borst) onto the Instylla Microcatheter shaft may result in damage to the microcatheter. • Precursor injection into high blood flow or directly near vessel branching may prevent embolic formation. If no evidence of embolic formation is present following the injection of 2mL liquid precursors (1mL of each precursor), reposition catheter tip and confirm appropriate position prior to additional injection. • Excess injection of Embrace HES may result in retrograde flow in the vessel leading to the embolization of other non-target tissues or organs.
- Ganguli, 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.
- Data on file at Instylla.