Controlled, targeted, and persistent embolization.
Embrace Hydrogel Embolic System (HES) is a minimally-invasive vascular embolization treatment that interventional radiologists can easily deliver for immediate, targeted, and persistent embolization.
- FDA-approved for Hypervascular Tumor Embolization
- Precise subselective embolization
- No catheter entrapment
- Simplified Workflow
- No imaging interference
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See Embrace HES in Action
Upon injection, two liquid precursors combine in the vessel to form the hydrogel in less than 2 seconds for rapid, sustained occlusion. Then, over approximately 11 months the hydrogel is absorbed via hydrolysis.1
1. Data on file at Instylla.
What physicians are saying
I am excited to have this wonderful new tool in the IR repertoire.
Nadine Abi-Jaoudeh, MD, FSIR
Chief of Interventional Radiology, UC Irvine · National PI
I was pleased that Embrace HES allowed me to achieve deep, distal penetration into the tumor vascular bed, which helped me tailor the embolization to the patient’s anatomy and treatment goals.
Ripal Gandhi, MD
Interventional Radiologist, Miami Cardiac & Vascular Institute
Embrace is next level — it allows deep tumor penetration for total blood flow occlusion. It resorbs with time, so nothing is left behind. I love it!
Edgar St. Amour, MD
Interventional Oncologist, CARTI Cancer Center
Supported by a Prospective, Randomized, Multicenter Clinical Trial
Embrace HES was evaluated against standard of care (SOC) and Transcatheter Arterial Embolization (TAE) / Chemoembolization (cTACE) procedures for the treatment of hypervascular tumors, with clinical and imaging follow-up at 30 and 90 days and clinical follow-up at 180 days.
Compared to 77.3% success with standard of care (SOC)
As adjudicated by the CEC*, with no adverse events designated as device-related only
In the Embrace HES arm vs. the SOC arm
Fewer additional embolization procedures in the Embrace HES arm beyond 90-day follow-up than the SOC arm
Disease control rate at 90 days across non-hepatic, non-HCC hepatic, and primary liver lesions
Associated with Embrace HES in the 148 treated vessels
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Indications for Use:
The Embrace HES is indicated for embolization of hypervascular tumors in peripheral arteries ≤ 5 mm.
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, or 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 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 procedure, and monitor patients who may be at risk.
- Safety of Embrace HES at injected volumes greater than 7.5 mL has not been evaluated. Total volume 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 for patients with bleeding diathesis or a hypercoagulative state, or who are immunocompromised.
- Do not use if any contents of the Embrace HES or package appear broken or damaged. Prior to use, verify the sterile package has not been damaged, and discard the unit if it has been damaged or unintentionally opened.
- For single use only; do not resterilize. Attempts to reuse or resterilize may compromise device integrity, lead to device failure, and create a risk of contamination or infection, which may result in patient injury, illness, or death.
- Dispose of used or unused material safely per your institution’s procedure for medical waste.
- All procedures must be performed according to accepted aseptic technique.
- Exercise care in handling the microcatheter 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 damage 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 injection of 2 mL of liquid precursors (1 mL of each), reposition the catheter tip and confirm appropriate position prior to additional injection.
- Excess injection of Embrace HES may result in retrograde flow, leading to embolization of non-target tissues or organs.
† As determined by an independent core lab. * Clinical Events Committee (CEC). ** Disease Control Rate includes Partial Responses, Complete Response, and Stable Disease.