FloShield Clinical Data Presented at SAGES

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Study shows “significantly reduced” need to remove laparoscope during surgery for cleaning and defogging

FloShield®, a clear sheath that mounts over a laparoscope and creates a vortex barrier of CO2 in front of the lens, was found to “significantly reduce the need to remove the laparoscope during surgery for purposes of cleaning/defogging,” according to findings presented at the recent Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Annual Conference.

The clinical study compared the use of FloShield versus the Clearify™ Visualization System (D-HELP) during laparoscopic surgery for the purpose of evaluating operative interruptions for lens cleaning. Overall, FloShield showed a statistically significant reduction in laparoscope removals, 56%, when compared to Clearify (p = 0.0194). Regardless of energy type used, FloShield also showed statistical significance versus Clearify; a 95% reduction in scope removals with electrocautery (p=0.0035), 51% reduction with harmonic (p=0.0482). Additionally, the post case surveys completed by the study investigators after each procedure resulted in the surgeons rating FloShield ‘excellent’ for the following factors collectively: overall video clarity, consistency of video clarity, and ability to see tissue planes.

The study was performed by Tayyab S. Diwan, M.D. (University of Cincinnati, Division of Transplantation), Juan Carlos Verdeja, M.D. (South Miami Hospital) and K. Warren Volker, M.D (Centennial Hills Medical Center).

“FloShield represents a truly innovative process of laparoscopic lens cleaning that can significantly limit a surgeon’s need to remove the scope, resulting in more efficient use of operative time,” said Dr. Diwan of the findings.

Typically, CO2 is only used to inflate the abdominal cavity and create a working space for the surgeon. FloShield directs a portion of CO2 over the optics of the laparoscope, helping prevent the accumulation of smoke and debris on the lens – while actively defogging it inside the patient.

Based on the study results, the investigators concluded that the reduction in laparoscope removals with FloShield has the potential to increase operating room efficiency through reducing surgical interruptions and improving video clarity.

About FloShield
FloShield is an innovative technology that helps maintain clear vision for the surgeon while minimizing interruptions in laparoscopic surgery. By helping prevent the accumulation of smoke and debris on the lens – while also actively defogging it – FloShield significantly reduces the need to remove the laparoscope. FloShield represents a dramatic advance from past and current methods to maintain laparoscopic visual clarity. For more product information go to www.floshield.com

About Minimally Invasive Devices, Inc. (MID)
Headquartered in Columbus, Ohio, Minimally Invasive Devices, Inc. (MID) is the creator of the FloShield family of products for improving laparoscopic clarity. For more information about MID: http://floshield.com/about