TVFMI

TVFMI

TITANIUM VOCAL FOLD MEDIALIZING IMPLANT (FRIEDRICH)

Implant system for external vocal fold medialization
Three diffrent sizes to realize almost all variations of intraoperative adjustments
No need for sizer or any additional instruments
Pure titanium for exceptional biocompatibility
Excellent documentation with scientific studies
MR conditional also for potential Tesla strenghs up to 7.0T

Product Information

Designed for external vocal fold medialization using a surgical approach developed, simplified and standardized by Prof. Gerhard Friedrich MD, (Graz, Austria).

Because of its cleverly simple and precisely engineered design, the TVFMI™ implant makes a vast multiplicity of shapes and sizes redundant. In fact, two sizes (one for men, one for women) and one instrument suffice to develop the variety of adaptations that may be required during surgery. For rare cases a special small size (11 mm) is additionally available.

The implant facilitates a precise medialisation and can easily be fixed due to its design. This helps reducing the risk of dislocation.

Benefits

Optimized implant placement through a customized design
No additional sizer or instrumentation necessary
Helps minimising inventory levels
Reversibility
Local anesthesia makes intraoperative speech function testing possible
Reduced risc of dislocation

Ordering Information

Ordering Information - TVFMI

Item	Size	REF
TVFMI / 11 x 4.5 x 0.25 mm	11 mm	5001 000
TVFMI / 13 x 6.0 x 0.25 mm	13 mm	5001 001
TVFMI / 15 x 6.0 x 0.25 mm	15 mm	5001 003

Material: Titanium (ASTM F67 Medical Grade)

Ordering Information - Accessories

Item	REF
TVFMI Bending Pliers	8000 131

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.

Literature

Longterm results after external vocal fold medialization thyroplasty with titanium vocal fold medialization implant (TVFMI).

Berit Schneider-Stickler, Johannes Gaechter, Wofgang Bigenzahn

Eur Arch Otorhinolaryngol (2013) 270: 1689-1694.

Medialization thyroplasty: vocal outcome of silicone and titanium implant.

Van Ardenne N, Vanderwegen J, Van Nuffelen G, De Bodt M, Van de Heyning P.

Eur Arch Otorhinolaryngol 2011 Jan; 268(1):101-7.

Concept for Diagnosis and Therapy of Unilateral Recurrent Laryngeal Nerve Paralysis Following Thoracic Surgery.

B. Schneider, B. Schickinger-Fischer, M. Zumtobel, G. Mancusi, W. Bigenzahn, W. Klepetko, A. End

Thorac Cardiov Surg 2003; 51: 327 - 331.

Literature

Functional results after External Vocal Fold Medialization Thyroplasty with the Titanium Vocal Fold Medializing Implant.

Berit Schneider, Doris-Maria Denk, Wolfgang Bigenzahn

Laryngoscope 2003, 113:628-634.

Acoustic assessment of the voice quality before and after medialization thyroplasty using the titanium vocal fold medialization implant (TVFMI™).

Berit Schneider, Doris-Maria Denk, Wolfgang Bigenzahn

Otolaryngology Head and Neck Surgery: June 2003.

Titanium Vocal Fold Medializing Implant: Introducing a novel implant system for External Vocal Fold Medialization.

Gerhard Friedrich, MD

Ann Otol Rhino Laryngol 1999, 108:79-86

DMS 0004032_Rev.01