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Lyoplant ® Onlay Adding another layer of confidence to every procedure Aesculap Neurosurgery

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Page 1: Lyoplant Onlay - Aesculap USA · Lyoplant® Onlay Adding another layer of confidence to every procedure For more than 140 years, Aesculap Neurosurgery has developed products that

Lyoplant® OnlayAdding another layer of confidence to every procedure

Aesculap Neurosurgery

Page 2: Lyoplant Onlay - Aesculap USA · Lyoplant® Onlay Adding another layer of confidence to every procedure For more than 140 years, Aesculap Neurosurgery has developed products that

Lyoplant® OnlayAdding another layer of confidence to every procedure

For more than 140 years, Aesculap

Neurosurgery has developed products

that expand surgical possibilities for

surgeons worldwide. Lyoplant Onlay

expands upon this philosophy in offering

a biological, absorbable dura

substitute consisting of a bilayer

membrane, designed to provide

superior protection and

ease of use.RELIABLE Helps protect against CSF leakage Excellent resorption rates Superior tensile strength* Strong biocompatibility

SIMPLE Familiar use Time-saving onlay application Convenient handling Superior suture pull-out*

VERSATILE Multi-use: Onlay or Suturable 40% thinner than competition* Excellent elasticity and flexibility Helps prevent cortical adhesion*Biomechanical data is on file at Aesculap, Inc.

Indications for Use

Lyoplant Onlay is indicated as a dura substitute for the repair of the dura matter.

See Instructions for Use for additional information, including warnings and precautions.

Rx Only

Page 3: Lyoplant Onlay - Aesculap USA · Lyoplant® Onlay Adding another layer of confidence to every procedure For more than 140 years, Aesculap Neurosurgery has developed products that

Lyoplant® OnlayA Multi-layer SOLUTION with a History you can TRUST!

Disclaimer: All testing results are based on averages. Tensile strength and Suture Retention testing were performed in a rehydrated state.

DuraGen is a registered trademark of Integra Life Sciences Corporation.

SEM image of Lyoplant® Onlay

Layer ❶ is a highly purified collagen element that is produced from bovine pericardium. This collagen is known for its low propensity to cause immunological reactions. It is the same strong and tear-proof material used for our well established suturable dura substitution Lyoplant.

The two layers are not chemically crosslinked.The close connection between the two layers as well as the production of the materials itself is obtained by a very gentle lyophilization (freeze drying) process.

Layer ❷ is also a highly purified collagen element, made from bovine split hide. The fleece-like spongy quality of this layer allows the implant to adhere to the dura around the defect. Thus, Lyoplant Onlay can be applied as an Onlay simply by laying the implant on the dura. This possibility of a sutureless closure of the dura defect can save valuable OR time.

Tensile Strength

70.0

60.0

50.0

40.0

30.0

20.0

10.0

LyoplantOnlay

SuturableDuraGen®

5.3

60.2

Long

itudi

nal S

tren

gth

[N]

Suture Retention

30.0

25.0

20.0

15.0

10.0

5.02.8

28.3

Sutu

re R

eten

tion

Stre

ngth

[mm

]

Material Thickness

4.5

4.0

3.5

3.0

2.5

2.0

1.5

1.0

0.5

4.3

2.6

Diam

eter

[N]

LyoplantOnlay

SuturableDuraGen®

LyoplantOnlay

SuturableDuraGen®

Lyoplant ®

units sold

> 500,000

10x higher tensile strength

compared to DuraGen Suturable

10x higher suture retention

compared to DuraGen Suturable

40% thinner than DuraGen

Suturable

Page 4: Lyoplant Onlay - Aesculap USA · Lyoplant® Onlay Adding another layer of confidence to every procedure For more than 140 years, Aesculap Neurosurgery has developed products that

Lyoplant® OnlayProduct Application

Lyoplant Onlay provides a reliable, simple and versatile solution to meet every patient need.

CUT■ Lyoplant Onlay can be cut in the required shape and size easily.

■ Onlay technique: The implant should overlap the dura defect by approx. 1 cm to ensure maximal adhesion and a liquid-tight seal.

■ Suturing: The implant should be cut as closely as possible to the defect size.

REHYDRATE■ Prior to implantation, Lyoplant Onlay is placed in sterile saline solution or in another isotonic solution to

ensure optimal conformity.

APPLY■ Ensure that the fleece-like, porous side (labeled ‘DURA SIDE’) is facing downward.

■ Onlay technique: The implant simply has to be laid flat against the defect edges, ensuring that it is not taut.

■ Suturing: If required and if considered necessary by the user, Lyoplant Onlay can be sutured in place. The implant should be fixed with non-absorbable suture material (polyester, polypropylene), using atraumatic round-bodied needles.

Page 5: Lyoplant Onlay - Aesculap USA · Lyoplant® Onlay Adding another layer of confidence to every procedure For more than 140 years, Aesculap Neurosurgery has developed products that

Sizes Content Item No.

2.5 x 2.5 cm 1“ x 1“ 1 piece 106 7010

5.0 x 5.0 cm 2“ x 2“ 1 piece 106 7020

2.5 x 7.5 cm 1“ x 3“ 1 piece 106 7030

7.5 x 7.5 cm 3“ x 3“ 1 piece 106 7040

10.0 x 12.5 cm 4“ x 5“ 1 piece 106 7050

0 cm 0”

2.5 cm 1”

5.0 cm 2”

7.5 cm 3”

10.0 cm 4”

0 cm 0”

2.5 cm 1”

5.0 cm 2”

7.5 cm 3”

10.0 cm 4”

12.5 cm 5”

106 7010

106 7020

106 7040 106 7030

106 7050

Lyoplant® OnlayConfigurations

The raw material’s origin is New Zealand, which is regarded as a BSE-free country by the WHO. Pericardium is a tissue proven to have no detectable infection potential.* Additionally the material is treated with NaOH (sodium hydroxide) to inactivate agents causing BSE.

*Data on file.

Page 6: Lyoplant Onlay - Aesculap USA · Lyoplant® Onlay Adding another layer of confidence to every procedure For more than 140 years, Aesculap Neurosurgery has developed products that

All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form. In the case of misuse we retain the rights to recall our catalogs and price lists and to take legal actions.

©2013 AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA.Aesculap is an equal opportunity employer

Aesculap, Inc. | 3773 Corporate Parkway | Center Valley, PA | 18034Phone 800-282-9000 | Fax 610-791-6886 | www.aesculapusa.com

Aesculap, Inc. - a B. Braun company DOC1118 Rev. A 2/14