Nitiflex stapes prosthesis in super elastic nitinol and titanium – CliP attachment / coupling for standardization

CliP made of superelastic nitinol which considerably reduces the attachment force.

Proven CliP technology which standardizes the coupling of the prosthesis to the long process.

Pure titanium piston body and end.

NITIFLEX STAPES PROSTHESIS

CliP made of superelastic 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

AN IMPORTANT EVOLUTION OF STAPES PROSTHESES

As opposed to conventional KURZ CliP prostheses, the NiTiFLEX has a loop made of superelastic nitinol which considerably reduces the attachment force. Consequently, it marks an important evolution of the stapes prostheses. In addition, the prosthesis features the same coupling benefits as earlier CliP stapes designs, such as an optimized acoustical transmission, open zones to facilitate vascular supply to the mucosa and contact points on the long process of the incus.

The distal end of the prosthesis is made of pure titanium. Easy coupling is achieved with the aid of the Soft CliP Hook.

Developed in close collaboration with Tuebingen University ENT Clinic and the Institute of Engineering and Computational Mechanics at the University of Stuttgart (ITM), Germany.

Benefits

Standardized coupling to the long process of the incus
Reduced attachment force
Optimized acoustical sound transmission
Facilitated vascular supply to the mucosa

Ordering Information

Ordering Information - ∅ 0.4 mm

LENGTH L (mm) ∅ 0.4 mm	REF
3.50	1007 203
3.75	1007 204
4.00	1007 205
4.25	1007 206
4.50	1007 207
4.75	1007 208
5.00	1007 209
5.50	1007 211

Material:

-Pure Titanium (ASTM F67 Medical Grade)

-Superelastic Nitinol

Band loop width: 0.25 mm

Ordering Information - ∅ 0.6 mm

LENGTH L (mm) ∅ 0.6 mm	REF
3.50	1007 253
3.75	1007 254
4.00	1007 255
4.25	1007 256
4.50	1007 257
4.75	1007 258
5.00	1007 259
5.50	1007 261

Material:

-Pure Titanium (ASTM F67 Medical Grade)

-Superelastic 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

Initial experience with the NiTiFLEX® Stapes Prosthesis

Zirkler J., Rahne T., Plontke S.

Published: 86th Annual Meeting of the German Society for Oto-, Rhino-, Laryngology,
Head and Neck Surgery. Berlin, May 13-16, 2015. Poster Abstract (German)

Literature

Initial experience with the NiTiFLEX® Stapes Prosthesis
at the ENT Hospital Erlangen

Brase C., Pohmer S., Stockmayer N., lro H., Hornung J.

Published: 86th Annual Meeting of the German Society for Oto- Rhino-
Laryngology, Head and Neck Surgery. Berlin, May 13-16, 2015. (German)