Merit Medical Embosphere Microspheres Sterile Vial IFU-US User Manual
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Interv Radiol, 12(1):39-44, Jan 2001.
6Worthington-Kirsch R, G Popky, F Hutchins:
Uterine arterial
embolization for the management of leiomyomas: Quality-of-life
assessment and clinical response. Radiol, 208: 625-629, 1998.
7.Pelage JP, Le Dref O, Soyer P, et al.: Fibroid-related menorrhagia:
Treatment with superselective embolization of the uterine arteries
and mid-term follow-up. Radiology, 215(2):428-431. May 2000.
All Indications
1.Bendszus M, Klein R, Burger R, et al.: Efficacy of trisacryl
gelatin microspheres versus polyvinyl alcohol particles in the
preoperative embolization of meningiomas. AJNR, 21(2): 255-
61, Feb 2000.
2. Deveikis JP:
Endovascular therapy of intracranial
arteriovenous malformations:
materials and techniques.
Neuroimaging Clin of N Am, 8(2):401-424, 1998.
3.Frizzel RT, Fisher WS:
Cure, morbidity, and mortality
associated
with
embolization
of
brain
arteriovenous
malformations: A review of 1246 patients in 32 series over a
35-year period. Neurosurg, 37(6):1031-1040, Dec 1995.
4.Gomes, A: Embolization therapy of congenital arteriovenous
malformations:
Use of alternative approaches.
Radiology,
190:191-8, Jan 1994.
5.Terada, T; Kinoshita, Y; Yokote, H; Tsuura, M; Itakura, T;
Komai, N; Nakamura, Y; Tanaka, S; Kuriyama, T: Preoperative
embolization of meningiomas fed by ophthalmic branch
arteries. Surg Neurol, 45:161-6, 1996.
Information on packaging:
Distributed in USA by:
Merit Medical Systems, Inc.
Customer Service
1-800-356-3748
781-681-7900
Patent Information
US 5,635,215 and other patent(s) issued and pending.
Embosphere Microspheres is a registered trademark of
BioSphere Medical.
All serious or life-threatening adverse events or deaths
associated with use of Embosphere Microspheres should
be reported to the U.S. Food and Drug Administration
under the MedWatch program and to the device
manufacturer. Information about the MedWatch
program and forms for reporting adverse events can be
obtained at
www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm
or by calling toll free 888-463-6332. Reports to
BioSphere Medical, Inc. can be made by calling toll free
800-394-0295.
Symbol
Designation
Manufacturer: Name & Address
Use by date: year-month
LOT
Batch code
REF
Catalogue number
STERILIZE
2
Do not resterilize
Do not use if package is damaged
Keep away from sunlight
Keep dry
2
Do not re-use
Caution - Refer to Instructions For Use
Non-pyrogenic
STERILE
Sterilized using steam
0°C
Lower limit of temperature