Clinical Evidence

Numerous clinical studies in leading, peer-reviewed journals have proven the ability of ViOptix tissue oximetry technology to:

Improve Flap Salvage Rates
  • Flap salvage rates increased from 57.7% to 93.75% 1
  • Total flap failure dropped from 9.4% to 1.3% 2
  • Operative exploration salvage rate improved from 0/4 (0%) to 3/3 (100%) 2
Reduce ICU & Total Patient Length of Stay
  • Total length of stay decreased from 14.5 days to 10.7 days using T.Ox2
  • Elimination of ICU stays can save the hospital $1,937 per patient3
Provide Faster Problem Identification
  • Identifies vascular compromise faster than the implantable Doppler4
  • Provides remote access to view flaps on any web browser and cell phone 24/7
Improve Clinical Confidence
  • Sensitivity and specificity clinically proven to be very high with no false negatives or false positives in 500+ flaps studied in clinical papers1,5

ViOptix Data Examples

The T.Ox system provides two critical pieces of data:

  • A number that reflects real-time oxygen saturation (StO2), updated every 4 seconds
  • A graph trending StO2 over time

The following images demonstrate examples of actual cases highlighting both tissue flaps with and without complications as noted on the T.Ox system.

Unilateral tissue flaps with no complications
Bilateral tissue flaps with no complications
http://www.vioptix.com/wp-content/uploads/2015/10/Vioptix-Clinical_12.png
http://www.vioptix.com/wp-content/uploads/2015/10/Vioptix-Clinical_13.png
http://www.vioptix.com/wp-content/uploads/2015/10/Vioptix-Clinical_14.png
Tissue flaps with complications, note the drop in StO2 levels reflected in the graphs
1

Tissue Oximetry Monitoring in Microsurgical Breast Reconstruction Decreases Flap Loss and Improves Rate of Flap Salvage. Samuel J. Lin, M.D., Minh-Doan Nguyen, M.D., Ph.D., Chen Chen, M.D., Salih Colakoglu, M.D., Michael S. Curtis, M.D., Adam M. Tobias, M.D., Bernard T. Lee, M.D.; Volume 127, Number 3, March 2011. Beth Israel Deaconess Medical Center/ Harvard Medical School, Boston, MA, USA.

2

Three-Year Experience Using Near Infrared Spectroscopy Tissue Oximetry Monitoring of Free Tissue Transfers. Mathew H. Steele, MD. Annals of Plastic Surgery. Volume 66, Number 5, May 2011.

3

Cost Analysis of Near-Infrared Spectroscopy Tissue Oximetry for Monitoring Autologous Free Tissue Breast Reconstruction. David H. Song, MD; Julie E. Park, MD; Charles Y. Tseng, MD; Aaron T. Pelletier, MD; Shailesh Agarwal, BS. Journal of Reconstructive Microsurgery, Volume 27, Number 8, July 2011.

4

A Prospective Analysis of Free Flap Monitoring Techniques: Physical Examination, External Doppler, Implantable Doppler, and Tissue Oximetry. Robert F. Lohman, Claude-Jean Langevin, Mehmet Bozkurt, Neilendu Kundu, Risal Djohan. Journal of Reconstructive Microsurgery, November 2012; 29(01): 051-056.

5

A New Diagnostic Algorithm for Early Prediction of Vascular Compromise in 208 Microsurgical Flaps Using Tissue Oxygen Saturation Measurements. Keller A. Annals of Plastic Surgery, May 2009; 62(5): 538-543

  • ViOptix T.Ox has allowed me to transfer patients to a lower level of care to a regular floor earlier in the post-operative period.

    Loren S. Schechter, MD

    ViOptix is critical for building a microsurgery practice in the real world. In essence, we believe the product is making microsurgery more manageable.

    Dr. Ergun Kocak, MD MS

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