Merit Medical Embosphere Mode D'emploi page 10

8. Carnevale FC, Iscaife A, Yoshinaga EM, et al. Transurethral resection of the
prostate (TURP) versus original and PErFecTED prostate artery embolization (PAE)
due to benign prostatic hyperplasia (BPH): preliminary results of a single center,
prospective, urodynamic-controlled analysis. Cardiovasc Intervent Radiol 2016;
39(1):44-52. DOI 10.1007/s00270-015-1202-4.
9. de Assis AM, Moreira AM, de Paula Rodrigues VC, et al. Prostatic artery
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11. Grosso M, Balderi A, Arnò M, et al. Prostatic artery embolization in benign
prostatic hyperplasia: preliminary results in 13 patients. Radiol Med 2014;
120(4):361-8. DOI 10.1007/s11547-014-0447-3.
12. Kably I, Pereira K, Chong W, et al. Prostate artery embolization (PAE) in the
management of refractory hematuria of prostatic origin secondary to iatrogenic
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13. Khayrutdinov ER, Zharikov SB, Vorontsov IM, et al. Our first experience with
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14. Kurbatov D, Russo GI, Lepetukhin A, et al. Prostatic artery embolization for
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15. Laborda A, de Assis AM, Ioakeim I, et al. Radiodermitis after prostatic artery
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All indications 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:
Symbol
Manufacturer: Name & Address
Use by date: year-month-day
LOT Batch code
REF Catalog 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
Lower limit of temperature
Designation
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 Merit Medical, Inc. can be
made by calling toll free 800-394-0295.
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