Medtronic 9135004 Instructions for Use
ACTIVENT®
ANTIMICROBIAL VENTILATION
(TYMPANOSTOMY) TUBES
PRODUCT INFORMATION AND INSTRUCTIONS
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, FL USA 32216-0980
800-874-5797 or 904-296-9600
www.medtronicENT.com
Rx Only
® are registered marks of Medtronic Xomed, Inc.
68E3274 B 02/11
INTENDED USE:
When inserted through a myringotomy, the Medtronic Xomed ACTIVENT® Antimicrobial
Ventilation Tube provides a passageway for movement of air between the auditory canal and the
middle ear. e unobstructed passageway may also allow a means of drainage of uids resulting
from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical
placement of ventilation tubes also provides a means of equalizing air pressures between the outer
ear and the middle ear and continued ventilation to prevent uid accumulation within the middle ear.
DEVICE DESCRIPTION:
Medtronic Xomed ACTIVENT® Antimicrobial Ventilation (Tympanostomy) Tubes are small tubular
implants constructed of a biocompatable material with bacteriocidal/bacteriostatic properties which
has been shown to reduce the incidence of post-operative otorrhea. ACTIVENT® Antimicrobial
Ventilation Tubes are fabricated from silver oxide and silicone or silver oxide and uoroplastic
material. Numerous designs and sizes are available with single or multiple anges to satisfy various
surgical techniques for insertion and to facilitate short or long term communication of the auditory
canal with the middle ear.
In Vitro Testing:
Medtronic Xomed ACTIVENT® Antimicrobial Ventilation Tubes were placed in media and
inoculated with both a wide spectrum of organisms and ones commonly associated with otitis
media infections1. Results demonstrated the bacteriocidal/bacteriostatic properties of the tube.
Following is a list of the microorganisms tested:
Candida albicans
Aspergillus niger
Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus
Corynebacterium xerosis
Staphylococcus epidermidis
Clinical Testing:
Clinical trial data2 demonstrated a reduced incidence of post-operative otorrhea associated with
the ACTIVENT® Antimicrobial Ventilation Tube when compared to control tubes over a period of
39 weeks; see the following graph. e eectiveness of the tube in reducing post-operative otorrhea
beyond 39 weeks has not been established.
CONTRAINDICATIONS:
Some conditions for which ventilation tubes may not be the therapy of choice include:
• Cases of otitis media which respond favorably to drug therapy alone.
• Cases of otitis media in which, in the medical judgement of the surgeon, a myringotomy alone
or tympanocentesis will suce as treatment for the condition.
POSSIBLE ADVERSE EFFECTS:
• e middle ear may develop subsequent secondary infections from either water or airborne
pathogens. (Care should be taken to avoid water entering the ear.)
• Clogging of the tube which may require removal and replacement.
• Persistent perforation of the tympanum aer tube extrusion.
• Granulomatosis reaction of the tympanum necessitating tube removal.
• Premature extrusion of the tube.
• Failure of the tube to self-extrude requiring medical intervention for removal.
• Allergic reaction may occur in patients with metals sensitivity.
e Medtronic Xomed ACTIVENT® Antimicrobial Ventilation Tube was evaluated in a 12 month
study3 in the middle ear of animals. While the ACTIVENT® Antimicrobial Ventilation Tube was
formed of silicone and silver oxide and was shown to be bacteriocidal/bacteriostatic, the study
showed that the material produced no signicant adverse eects compared to silicone control
material. Nevertheless, the long term eects of the ACTIVENT® Antimicrobial Ventilation Tube
displaced into the middle ear are unknown.
PRECAUTIONS:
Larger tube diameters and increasing ange size may increase the chances of prolonged tube retention
and/or residual perforation. e surgeon is encouraged to carefully choose a tube size, style and
material to meet the needs of each specic clinical situation, while minimizing adverse eects.
STERILITY:
Medtronic Xomed ACTIVENT® Antimicrobial Ventilation Tubes are provided STERILE, being
terminally sterilized by ethylene oxide (ETO) gas in a highly controlled environment. e package
should be carefully inspected for punctures, tears, security of the seal or any other evidence of the
sealed pouch having been compromised prior to placement of the contents in the sterile eld. e
product is sterile in an undamaged, unopened package.
14%
12%
10%
8%
6%
4%
with Otorrhea
Percent of Visits
2%
50
10
0
Weeks after Implantation
CONTROL
20
30
40
ACTIVENT
INDICATIONS FOR USE:
e surgeon must use medical judgement and consider the patient’s medical history prior to a
decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes
are indicated include but are not limited to:
• Chronic otitis media with eusion characterized as either serous, mucoid, or purulent.
• Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
• A patient with a history of persistent high negative middle ear pressure which may be associated
with conductive hearing loss, otalgia, vertigo and/or tinnitus.
• Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction.
1
Microbiology of Chronic Suppurative Otitis Media in Children, Kenna, Margaret A., Pediatric
Infectious Diseases, Vol. 5, No. 2, March-April, 1986, pp. 223-225.
2
Antimicrobial Activity of Silver Oxide Impregnated Silastic® Tympanostomy Tubes: A Double
Blind Randomized Multicenter Trial, Chole, Richard A., et al., Archives of Otolaryngology-Head
& Neck Surgery, Vol. 121, No.5, May 1995, pp. 562-565.
3
Safety of Silver Oxide Impregnated Silastic® Tympanostomy Tubes, Chole, Richard A., and Brummet,
Robert E., et al., American Journal of Otology, 1995, Vol. 16, No. 6, November, 1995, pp. 722-724.
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