Predictable. Precise. Proven.
Transcription
Predictable. Precise. Proven.
Predictable. Precise. Proven. Embolic material is injected into selected vessels to block the blood flow feeding the tumor or malformation, causing it to shrink over time. LC Bead microspheres are compressible, visibly-tinted N-fil Hydrogel microspheres supplied in convenient single 2 ml vials. Tumor < Catheter BENEFITS • Tinted beads for immediate enhanced visualization prior to delivery • Compressible design for smooth catheter delivery and predictable vessel conformity • Size calibrated to ensure the proper bead diameter is administered to patients • Maintains spherical shape and compressible design even when mixed with positively charged materials or non-ionic agents • Multiple peer reviewed articles outlining the safety, precision and predictability of the N-fil PVA microsphere Label Color Part # Size (µm) Volume (beads only) Yellow VE 220GS 100-300 2 ml Blue VE 420GS 300-500 2 ml Red VE 620GS 500-700 2 ml LC Bead Embolic Agent is manufactured for AngioDynamics by Biocompatibles International plc 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 the sale of this device 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: Procedurerelated 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. USA > 603 Queensbury Avenue, Queensbury, NY 12804 > tel: 800-772-6446 or 518-798-1215 > fax: 518-798-1360 International > Building 2000, Beach Drive, IQ Cambridge, Waterbeach, Cambridge, CB25 9TE > United Kingdom tel: +44 1223 729 300 > fax: +44 1223 729 349 www.angiodynamics.com AngioDynamics is a registered trademark of AngioDynamics, Inc. LC Bead is a trademark of Biocompatibles UK Ltd. © 2010 AngioDynamics, Inc. MLC 344 US Rev A