Merit Medical EmboGold Microspheres Prefilled Syringe IFU-US - Manual (Page 5)

• Choose a delivery catheter based on the size of the target vessel
and the microsphere size being used. EmboGold Microspheres can
tolerate temporary compression of up to 33% in order to facilitate
passage through the delivery catheter.
• EmboGold Microspheres are not radiopaque. It is recommended
that the embolization be monitored using fluoroscopic visualization
by adding the appropriate amount of contrast medium to the
physiologic saline suspension fluid.
• To deliver EmboGold Microspheres:
Match the total volume in the syringe with the same volume of
undiluted contrast, which will result in a 50% microsphere/saline
and 50% contrast solution. Remove all air from the syringe. To
evenly suspend the EmboGold Microsphere/contrast solution,
gently invert the 20mL syringe several times. Attach the 20mL
syringe to one port of the luer-lock 3-way stopcock; attach a 1mL
or 3mL injection syringe to another port on the stopcock, and, if
desired, a delivery catheter may be attached to the remaining port
on the stopcock. Wait several minutes to allow the EmboGold
Microspheres
to suspend properly. Draw EmboGold
Microsphere/contrast solution into the injection syringe slowly and
gently to minimize the potential of introducing air into the system.
Purge all air from the system prior to injection. Inject the EmboGold
Microsphere/ contrast solution under fluoroscopic visualization with
the injection syringe, using a slow pulsatile injection, while
observing the contrast flow rate. If there is no effect on the flow
rate, repeat the delivery process with additional injections of
EmboGold Microsphere/contrast solution, or larger sized EmboGold
Microspheres
may be considered. If the EmboGold
Microsphere/contrast solution requires resuspension, gently invert
the 20mL syringe several times. Exercise conservative judgment in
determining the embolization endpoint.
• Femoral puncture can result in arterial spasm. This may
predispose to femoral thrombosis (e.g. leg injury). Femoral patency
should be re-assessed prior to final catheter removal.
• Upon completion of the treatment, remove the catheter while
maintaining gentle suction so as not to dislodge EmboGold
Microspheres still within the catheter lumen.
• Apply pressure to the puncture site until hemostatis is complete.
• Discard any open, unused EmboGold Microspheres.
REFERENCES :
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.
EmboGold Microspheres is a registered trademark of BioSphere
Medical.
All serious or life-threatening adverse events or deaths associated
with use of EmboGold 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.
5
Symbol Designation
Manufacturer: Name & Address
Use by date: year-month
Batch code
Catalogue number
Do not resterilize
Do not use if package is damaged
Keep away from sunlight
Keep dry
Do not re-use
Caution - Refer to Instructions For Use
Non-pyrogenic
Sterilized using steam
0°C
Lower limit of temperature
STERILIZE
2
2
LOT
REF
STERILE