NITIBOND® STAPES PROSTHESIS

Pure titanium body and piston end

Flat wide loop band reduces risk of pressure points. Loop is designed to control heat transfer to the incus mucosa.

Crimp-free coupling: Three laser activated ThermoActive activation zones. Elasticity of the activation zones ensures uniformly attachment. Four contact zones interface with the surface of the mucosa.

NITIBOND® STAPES PROSTHESIS

CliP made of shape memory heat activated nitinol
Self-retaining
Standardized coupling
Crimp-free coupling
Rounded distal end of the prosthesis
Rounded between the piston segment and the loop area
Fixed length availability
Distal end diameter 0.4 and 0.6 mm
Piston surgical technique
MR conditional for the future: 7.0 Tesla

Product Information

CRIMP-FREE COUPLING

The NiTiBOND Stapes Prosthesis is a crimp-free prosthesis, that combines proven properties of CliP Stapes Prostheses with the benefits of shape memory heat activated nitinol. Extensive experience in the development of stapes prostheses, knowledge of the middle ear, creates the basis for a geometry of the unique nitinol loop making it suitable for almost all incus sizes.

The nitinol loop has four integrated contact zones, conforming to the asymmetrical dimensions of the incus. Additionally, the loop also features three independent activation zones which keep thermal transfer from the mucosa surface during laser activation. These activation zones can be sequentially closed producing a custom coupling to the individualized incus.

The laser settings are determined outside the middle ear with the aid of the Thermo-Dummy. The dummy is delivered together with the NiTiBOND.

Developed in close collaboration with the ORL Clinic of the University Hospital Zuerich and the Institute of Engineering and Computational Mechanics at the University of Stuttgart, Germany.

Benefits

Suitable for almost all incus sizes
Reduced risk of pressure points
Minimized head transfer to the mucosa
Reduced risk in laser setup

Ordering Information

Ordering Information - ∅ 0.4 mm

LENGTH L (mm) ∅ 0.4 mm	REF
3.50	1007 103
3.75	1007 104
4.00	1007 105
4.25	1007 106
4.50	1007 107
4.75	1007 108
5.00	1007 109
5.50	1007 111

Material:

-Pure Titanium (ASTM F67 Medical Grade)

-Nitinol

Band Loop width: 0.25 mm

Ordering Information - ∅ 0.6 mm

LENGTH L (mm) ∅ 0.6 mm	REF
3.50	1007 153
3.75	1007 154
4.00	1007 155
4.25	1007 156
4.50	1007 157
4.75	1007 158
5.00	1007 159
5.50	1007 161

Material:

-Pure Titanium (ASTM F67 Medical Grade)

-Nitinol

Band Loop width: 0.25 mm

Prescription Devices Caution:

United States Federal Law restricts devices identified herein to sale by or on the order of a physician.
These pages do not replace nor do they set forth the complete contents of the “Instructions for Use” for the products shown here, and are not substitute for reviewing and understanding that important information. Therefore, before using any products included here, please review the entire contents of the respective “Instructions for Use” information.
Because of registration the product is currently not available in all countries.

PRODUCT VIDEO

Literature

Next generation shape memory prosthesis (NiTiBOND) for stapedotomy:
Short-term results

Green JD, McElveen JT.

Laryngoscope. 2017 Apr;127(4):915-920. doi: 10.1002/lary.26114. Epub 2016 Jun 14.

How to Avoid a Learning Curve in Stapedotomy: A Standardized Surgical Technique

Kwok P., Gleich O., Dalles K, Mayr E., Jacob P., Strutz J.

Published: Otology & Neurotology 2017 Aug;38(7):931-937.

Promising Clinical Results of an Innovative Self-Crimping Stapes Prosthesis in Otosclerosis Surgery

Schrötzlmair F., Suchan F., Kisser U., Hempel J.-M., Sroka R., Müller J.

Published: Otology & Neurotology: December 2013 - Volume 34 - Issue 9 - p 1571–1575.

Literatur

Early functional results using the NiTiBOND® prosthesis in stapes surgery

Canu G., Lauretani F., Russo F. Y., Ferrary E., Lamas G.,Sterkers O., De Seta D., Bernardeschi D.

Published: Acta Otolaryngol. 2016 Nov 4:1-6

Mid-Term Results After a Newly Designed Nitinol Stapes Prosthesis Use in 46 Patients

Röösli C., Huber A. M.

Published: Otology & Neurotology 2013 Sep; 34(7)

Clinical Evaluation of the NiTiBOND Stapes Prosthesis, an Optimized Shape Memory Alloy Design

Huber A. M., Schrepfer T., Eiber A. †

Published: Otology & Neurotology: February 2012 - Volume 33

DMS 0004015_Rev.01