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Gel Embolic Material (GEM™)
Vascular Embolization Device

Indications, Safety, and Warnings


Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions

INTENDED USE/INDICATIONS FOR USE

GEM is indicated for use in the embolization of: 

  • Hypervascular tumors, 
  • Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature.

CONTRAINDICATIONS

  • Patients with a known hypersensitivity to porcine products 
  • Patients intolerant to occlusion procedures
  • Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
  • Presence or likely onset of vasospasm
  • Presence of severe atheromatous disease
  • Presence of collateral vessel pathways potentially endangering non-target vascular territories during embolization
  • Presence of arteries supplying the lesion not large enough to accept the selected device
  • Vascular resistance peripheral to the feeding arteries precluding passage of the product 
  • 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
  • Coronary and intracerebral vascular use
  • Presence of patent extra-to-intracranial anastomoses or shunts
  • Presence of end arteries leading directly to cranial nervesIn any vasculature where the product could pass directly into the internal carotid artery, vertebral artery, intracranial vasculature or the above listed vessels 

WARNINGS

  • Performing therapeutic embolization to occlude blood vessels is a high-risk procedure. Perform the procedure only under the direction of personnel with vascular embolization training and thorough knowledge of angiographic techniques.
  • GEM contains gelatin of porcine origin, and therefore, could cause an immune reaction in patients who are hypersensitive to collagen or gelatin. Careful consideration should be given prior to using this product in patients who are suspected to be allergic to injections containing gelatin.
  • The physician should be sure to carefully select the amount of the GEM used according to the size of the catheter appropriate for the target vessels at the desired level of occlusion in the vasculature. 
  • As with any embolization device, non-target embolization may potentially lead to significant complications; 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 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 that may be at risk. 
  • Onset of radiation-induced injury to the patient may be delayed. Patients should be counseled on potential radiation side effects and whom they should contact if they show symptoms. 
  • Pay careful attention for signs of non-targeted embolization. During injection carefully monitor patient vital signs to include SpO2 (e.g. hypoxia, central nervous system changes). Consider terminating the procedure and investigating for possible shunting if non-target embolization is suspected or patient symptoms develop. 
  • Avoid embolization near branch points as this may increase the risk of non-target embolization. 
  • Consider increasing amount of GEM injected if angiographic evidence of embolization does not quickly appear evident during GEM injection. 
  • Post embolization swelling may result in ischemia to tissue adjacent to target area. Care must be given to avoid ischemia intolerant, nontargeted tissue such as nervous tissue. 

PRECAUTIONS

Additional evaluations or precautions may be necessary in managing periprocedural care for patients with conditions such as, but not limited to bleeding diathesis or hypercoagulative state and Immunocompromise.

POTENTIAL COMPLICATIONS

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 non-targeted embolization or ischemic injury from adjacent tissue edema 
  • Undesirable reflux or passage of GEM into non-target arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds of systemic circulation or, pulmonary, or coronary circulations. 
  • Pulmonary embolism and/or stroke due to arterial-venous shunting, for example from a patent-foramen ovale. 
  • Ischemia at an undesirable location including ischemic stroke, ischemic infarction (including myocardial infarction), and tissue necrosis 
  • Capillary bed occlusion and tissue damage, which may lead to abscess formation and sepsis. 
  • Vessel or lesion rupture and hemorrhage 
  • Recanalization 
  • 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 dislodgment, and nerve and/or circulatory injuries, which may result in leg injury) 
  • Allergic reaction to medications (e.g. analgesics) 
  • Allergic reaction to contrast media or embolic material 
  • Pain and/or rash, possibly delayed from the time of embolization 
  • Death 
  • Blindness, hearing loss, loss of smell, and/or paralysis 
  • Neurological deficits, including cranial nerve palsies 
  • Additional information is found in the Warnings section 
PI-1390805-AB
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