Olympus OtoMimix® Quick Reference Guide

Indications for Use

Incudostapedial Joint Discontinuity

Reconstructing the conductive component by placing a small aliquot of OtoMimix HA cement on discontinuity.

[Illustration showing incudostapedial joint discontinuity repair]

Revision Stapes Replacement Due to Incus Erosion

Keeping the prosthesis properly positioned about the vestibule by extending and connecting the piston loop and the distal incus remnant.

[Illustration showing revision stapes replacement]

Stabilizing the Crimped Loop onto the Incus

Concerned about piston loop lifting off the incus, lock it down with a small aliquot of OtoMimix.

[Illustration showing stabilizing a crimped loop onto the incus]

No More Prop and Pray

Maximize columella prosthesis stability with an OtoMimix interface, connecting the prosthesis head to the malleus. (TORP® or PORP®)

[Illustration showing prosthesis head connected to malleus]

Mixing Guidelines

Mixing should always be performed by the operating surgeon.

  1. Pour the powder, followed by the liquid, into a sterile mixing container, taking care not to spill any material. Ensure that all contents of the vials have been emptied.
  2. Using an appropriate non-porous mixing instrument, mix the powder and liquid together for 30-45 seconds until a homogenous mixture is formed. (Do not use wooden tongue blade)
  3. Wait until a dough-like consistency has been achieved before applying OtoMimix. The dough-like consistency can be verified by using a Rosen needle to make an indentation in the cement which does not fill back in. Working time is typically 2-4 minutes.
  4. Allow the material to harden before closing. This can be verified by palpation with an appropriate instrument.

[Image showing mixing process]

*These guidelines are not a substitute for reading and learning the Instructions For Use, provided with the OtoMimix System, prior to use. All mixing times are approximate and may vary. Mixing container and spatula not included with product.

Surgical Technique

  1. Prior to using OtoMimix, complete all mastoid and middle ear removal of disease. After creating as bloodless a field as possible, place all grafts and supporting absorbable materials.
  2. If a prosthesis is to be secured with OtoMimix, check the fit and length of the prosthesis. Next, remove a small area of the mucosal layer on the manubrium of the malleus and/or the lenticular process of the incus where the prosthesis will rest and/or OtoMimix will be applied. Place the prosthesis (where applicable).
  3. After the site is prepared for OtoMimix placement (as described in steps 1 and 2), bring the OtoMimix onto the field and mix the liquid and powder thoroughly into a thick paste (see mixing guidelines). Pick up a small amount of prepared OtoMimix with the OtoMimix fork applicator or Rosen needle and apply to the ossicle/prosthesis or ossicle/ossicle interface. Carefully suction any OtoMimix that may spread to adjacent tissue.
  4. Once the OtoMimix is in place, do not disturb the repair for 5-7 minutes to allow the OtoMimix to harden. After 5-7 minutes, the OtoMimix may lose its sheen and will be hard to the touch. At this time the tympanic membrane flap can be brought over the repair and the ear closed.

NOTE: If any other repair is planned using OtoMimix (i.e. posterior canal wall reconstruction), repair these areas first before cementing the ossicular repair to avoid movement at the ossicle/prosthesis or ossicle/ossicle interface. OtoMimix is contraindicated for applications requiring placement directly on the footplate of the stapes.

Ordering Information

Catalog Number Description
70143266 OtoMimix® - 2 gram
130725 Rosen Needle, Sharp
130726 Rosen Needle, Dull

Contact Information

For more information call 800.262.3540

For order inquiries call 800.773.4301

or visit us at www.gyrusacmi.com

ENT BUSINESS GROUP:

Gyrus ENT, L.L.C.
2925 Appling Road
Bartlett, TN 38133
TEL 1-901-373-0200
FAX 1-800-757-2942

US Headquarters:

Gyrus ACMI, Inc.
136 Turnpike Road
Southborough, MA 01772
TEL 1-508-804-2600

Sales Locations:

USA

Gyrus ACMI L.P.
6655 Wedgwood Rd, Suite 160
Maple Grove, MN 55311
TEL 1-763-416-3000

Canada

Olympus Canada, Inc.
151 Telson Road
Markham, Ontario L3R 1E7
Canada
TEL 1-800-387-0437

Latin America

Olympus Latin America
5301 Blue Lagoon Drive, Suite 290
Miami, FL 33126, United States of America
TEL 1-305-266-2332

UK

KeyMed Ltd
KeyMed House
Stock Road
Southend-on-Sea, Essex SS2 5QH
United Kingdom
TEL 44-0-1702-616333

Europe

Olympus Medical Systems Europa GmbH
Wendenstr. 14-18
20097 Hamburg
Germany
TEL 49-40-23773-0

Australia

Olympus Australia Pty Ltd.
31 Gilby Road
Mount Waverley
Victoria 3149
Australia
TEL 61-1300-132-992

Hong Kong

Olympus Hong Kong and China Ltd.
L43, Office Tower, Langham Place
8 Argyle Street, Mongkok
Kowloon, Hong Kong
TEL 85-2-2481-7812

Korea

Olympus Korea Co., Ltd.
4F, Gyeongam Bldg.
Kangnam-Gu, Seoul, 135-090
Korea
TEL 82-2-6207-3200

Singapore

Olympus Singapore PTE Ltd.
491B River Valley Road #12-01/04
Valley Point Office Tower
Singapore 248373
TEL 65-6834-0010

China

Olympus Sales & Service Co., Ltd.
R1202, NCI Tower, A12 Jianguomenwa Ave.
Chaoyang District
Beijing, 100022, China
TEL 010-65693535

The procedure contained herein is that of Joel A. Goebel, M.D., F.A.C.S., Professor and Vice Chairman, Otolaryngology-Head and Neck Surgery, Washington University School of Medicine and not Gyrus ENT, LLC and is not necessarily recommended by Gyrus ENT, LLC.

2011 Gyrus ENT, L.L.C. All Rights Reserved. All trademarks and registered trademarks listed herein are the property of their respective holders.

Document version: 2011-08 Rev. AB 70608055

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