SPEED • PRECISION • CONSISTENCY.™

Merit’s EmboCube® brings speed, precision and consistency to gelatin foam. EmboCube is uniformly cut gelatin foam pre-loaded into a Medallion® syringe, allowing for faster preparation and accurate delivery.

EmboCube Embolization Gelatin consists of biocompatible, hydrophilic and dry pre-cut cubes of resorbable porcine gelatin packaged in a 10 mL syringe with a standard luer lock tip.

EmboCube Embolization Gelatin is indicated for use in embolization of blood vessels to occlude blood flow for controlling bleeding/ hemorrhaging. EmboCube Embolization Gelatin occludes vessels up to 5 mm. EmboCube Embolization Gelatin is intended to be used in adults.

CONTRAINDICATIONS

• Patients unable to tolerate vascular occlusion procedures

• Vascular anatomy precluding correct catheter placement

• Feeding arteries too small to accept the selected EmboCube Embolization Gelatin

• Presence or suspicion of vasospasm

• Coronary and intracerebral vascular use

• Presence of distal arteries directly supplying cranial nerves

• Presence of patent extra-to-intracranial anastomoses

• High-flow arteriovenous shunts or with a diameter greater than the selected EmboCube Embolization Gelatin

• Use in the pulmonary vasculature

• Use in pre-operative portal vein embolization (PVE)

• Severe atherosclerosis

• Patients with known allergy to gelatin

CAUTIONS

• DO NOT USE THIS PREFILLED SYRINGE TO DIRECTLY INJECT EMBOCUBE EMBOLIZATION GELATIN. THIS IS A “RESERVOIR” SYRINGE. Use of a 1mL or 3mL syringe provides more controlled delivery and helps to avoid non-target embolization. PLEASE REFER TO INSTRUCTIONS FOR USE PARAGRAPH.

• EmboCube Embolization gelatin must only be used by specialist physicians trained in vascular embolization procedures. The size and quantity of EmboCube Embolization Gelatin must be carefully selected according to the lesion to be treated, entirely under the physician’s responsibility. Only the physician can decide the most appropriate time to stop the injection of EmboCube Embolization Gelatin.

• Do not use the EmboCube Embolization Gelatin if the syringe or packaging appear damaged.

• For single patient use only – Contents supplied sterile - Never reuse, reprocess or resterilize the contents of a syringe. Reusing, reprocessing or resterilizing 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 of the patient. All procedures must be performed according to accepted aseptic technique.

• There is no testing done on using EmboCube with agents such as chemotherapies, sterile water, or lipiodol. 

Vascular embolization is a high risk procedure. Complications may occur at any time during or after the procedure, and may include, but are not limited to, the following:

• Stroke or cerebral infarction

• Occlusion of vessels in healthy territories

• Vascular rupture

• Neurological deficits

• Infection or haematoma at the injection site

• Allergic reaction, cutaneous irritations

• Transient pain and fever

• Vasospasm

• Death

• Ischaemia at an undesirable location, including ischaemic stroke, ischaemic infarction (including myocardial infarction), and tissue necrosis

• Blindness, hearing loss, loss of smell, and/or paralysis

• Additional information is found in the Warnings section