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