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LC Bead™

Predictable, Precise, Proven.

LC Beads are compressible, visibly-tinted N-Fil hydrogel beads supplied in convenient pre-prepared single vials. Embolic material is injected into selected vessels to block the blood flow feeding the tumour or malformation, causing it to shrink over time.

Features:
  • Predictable – tinted blue for immediate enhanced visualization prior to delivery and   sold as single vials to allow user the option of choosing an exact desired quantity
  • Precise – industry standard size ranges for ease in selectivity and wide array of calibrated bead sizes designed to ensure precise match to targeted vessels
  • Proven – a sulfonate modified N-Fil hydrogel microsphere
    supported by multiple peer reviewed scientific publications

 

Important Risk Information

INDICATION FOR USE: The LC Bead™ Embolic Agent is comprised of a range of hydrogel microspheres that are biocompatible, hydrophilic, nonresorbable and precisely calibrated. LC Bead microspheres are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. CONTRAINDICATIONS: Patients intolerant to occlusion procedures. Vascular anatomy or blood flow that precludes catheter placement or emboli injection. Presence or likely onset of vasospasm or hemorrhage. Presence of: severe atheromatous disease, patent extra-to-intracranial anastomoses or shunts, collateral vessel pathways potentially endangering normal territories during embolization, end arteries leading directly to cranial nerves, arteries supplying the lesion too small to accept LC Bead microspheres, or vascular resistance peripheral to the feeding arteries precluding passage of LC Bead microspheres into the lesion. Do not use LC Bead microspheres in the following applications: embolization of large diameter arteriovenous shunts, pulmonary arterial vasculature, or any vasculature where the use of LC Bead microspheres could pass directly into the internal carotid artery or the above listed vessels. WARNINGS AND PRECAUTIONS: Sterile and single use product. Do not reuse. Do not use if the vial or packaging appear damaged. Select the size and quantity of LC Bead microspheres appropriate for the pathology to be treated. Embolization with LC Bead microspheres should only be performed by physicians who have received appropriate interventional occlusion training in the region intended to be embolized. Please see package insert for complete list of warnings and precautions. POTENTIAL COMPLICATIONS: Procedure-related and surgical complications including: undesirable reflux or passage of LC Bead microspheres into normal arteries adjacent to the targeted lesion or through the lesion into arterial beds, pulmonary embolization, capillary bed saturation and tissue damage, ischaemic stroke or infarction or ischemia at an undesirable location, vessel or lesion rupture and hemorrhage, neurological deficits, death, recanalization, foreign body reactions or infection necessitating medical intervention, or clot formation at the tip of the catheter and subsequent dislodgement.

Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

 

 LC Bead is distributed by AngioDynamics and manufactured by Biocompatibles International plc. Visit Biocompatibles on the Web at www.biocompatibles.com.