Predictable, Flow-Directed Targeting

QuadraSphere® Microspheres are calibrated, hydrophilic and compress up to 80% to facilitate smooth microcatheter delivery. Once through the microcatheter, they rebound to their stated spherical shape with a consistent cross-sectional diameter for predictable, flow-directed targeting. 

Targeted Occlusion

The in vivo median diameter of occluded arteries is significantly different between sizes of QuadraSphere Microspheres,* providing targeted occlusion.

QuadraSphere Q2 Microspheres demonstrate a median occlusion of 78 µm, a statistically significant difference compared to larger sizes of QuadraSphere.

*Swine liver embolization model study performed for Merit Medical. QuadraSphere Microspheres prepared in 50/50 mixture of saline/contrast.

Angiographies of hypervascularized tumor pre- and post-embolization illustrate the ability of QuadraSphere Microspheres to perform a targeted embolization.

Experience the Power of Conformability

QuadraSphere Microspheres are soft and easily conform to the vessel lumen for complete occlusion:

• Decreasing the risk of vessel recanalization1
• Enabling greater tumor necrosis2,3
• Providing optimal contact between the vessel wall and microsphere surface1,4
• Enhancing the embolic effect, reducing the amount of product needed to reach embolization endpoint1

 Established

QuadraSphere Microspheres are a recognized and accepted platform for targeted liver embolization. QuadraSphere Microspheres are indicated for:

• Hepatoma
• Arteriovenous Malformations (AVM)
• Hypervascular Tumors (HVT)

Super-Absorbent Polymer

Referred to as super-absorbent polymer (SAP) microspheres, QuadraSphere Microspheres are packaged dry, but once exposed to aqueous-based media, they swell to approximately 4x the size printed on the product label.

QuadraSphere® Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

• QuadraSphere Microspheres size must be chosen after consideration of the arteriovenous angiographic appearance. QuadraSphere Microspheres size should be selected to prevent passage from any artery to vein.

• Some of the QuadraSphere Microspheres may be slightly outside of the range, so the physician should be sure to carefully select the size of QuadraSphere Microspheres according to the size of the target vessels at the desired level of occlusion in the vasculature and after consideration of the arteriovenous angiographic appearance.

• Because of the significant complications of misembolization, extreme caution should be used for any procedures involving the extracranial circulation encompassing the head and neck, and the physician should carefully weigh the potential benefits of using embolization against the risks and potential complications of the procedure. These complications can include blindness, hearing loss, loss of smell, paralysis, and death.

• Serious radiation induced skin injury may occur to the patient due to long periods of fluoroscopic exposure, large patient, 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.

• Onset of radiation injury to the patient may be delayed. Patients should be counselled on potential radiation effects, what to look for and whom to contact if symptoms occur.

• QuadraSphere Microspheres MUST NOT be reconstituted in sterile water for injection. Reconstitution in sterile water results in extensive swelling that renders the injection of QuadraSphere microspheres very difficult or may prevent injection.

• Do not reconstitute QuadraSphere Microspheres with Lipiodol / Ethiodol.

• Pay careful attention for signs of mistargeted embolization. During injection carefully monitor patient vital signs to include SaO2 (e.g. hypoxia, CNS changes). Consider terminating the procedure, investigating for possible shunting, or increasing Microspheres size if any signs of mistargeting occur or patient symptoms develop.

• Consider upsizing the Microspheres if angiographic evidence of embolization does not quickly appear evident during injection of the Microspheres

CONTRAINDICATIONS:

• Patients intolerant to vascular occlusion procedures

• Vascular anatomy or blood flow precluding correct catheter placement or embolic injection

• Presence or suspicion of vasospasm

• Presence or likely onset of hemorrhage

• Presence of severe atheromatous disease

• Feeding arteries too small to accept the selected QuadraSphere Microspheres

• Presence of collateral vessel pathways potentially endangering normal territories during embolization

• High flow arteriovenous shunts or fistulae with luminal diameter greater than the selected size of QuadraSphere Microspheres

• Vascular resistance peripheral to the feeding arteries precluding passage of QuadraSphere Microspheres into the lesion

• Presence of arteries supplying the lesion not large enough to accept QuadraSphere Microspheres

• Do not use in pulmonary vasculature, coronary and central nervous system vasculature

• Known sensitivity to poly vinyl alcohol-co-sodium acrylate

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:

• Paralysis resulting from untargeted embolization or ischemic injury from adjacent tissue oedema

• Undesirable reflux or passage of QuadraSphere Microspheres into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds, such as the internal carotid artery, pulmonary, or coronary circulation

• Pulmonary embolism due to arteriovenous shunting

• Ischemia at an undesired location, including ischemic stroke, ischemic infarction (including myocardial infarction), and tissue necrosis

• Capillary bed occlusion and tissue damage

• Vasospasm

• Recanalisation

• Blindness, hearing loss, and loss of smell

• Foreign body reactions necessitating medical intervention

• Infection necessitating medical intervention

• Complications related to catheterization (e.g. hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgement, and nerve and/or circulatory injuries which may result in leg injury)

• Allergic reaction to medications (e.g. analgesics)

• Allergic reaction to non-ionic contrast media or embolic material

• Vessel or lesion rupture and hemorrhage

• Death

• Additional information is found in the Warnings section