Minimally Invasive Surgery (“MIS”) utilizes optical devices (Endoscopes) inserted through very small incisions or natural body openings, to provide the surgeon with vision of the operating site. The surgeon then inserts specially designed surgical tools through the same or ancillary small incisions to perform the operation. Such operations minimize bleeding, cause fewer traumas, are less painful to the patient and require a shorter recovery period.
This is in contrast to its historical antecedent, “Open Surgery”, where a large body incision is made that allows the surgeon direct view of and access to the site of the operation. While this approach lends the advantage of depth perception to the surgeon's judgment, for the patient it causes trauma, pain, and a less comfortable and longer recovery period.
MIS vs. Open Surgery
Two Dimensional vs Three Dimensional Visualization
Today, 98% of MIS procedures utilize surgical endoscopes that provide two dimensional images. 2D systems lack the depth of vision provided by 3D systems. This can result in a greater likelihood of surgical errors (e.g. perforating a lung, damaging a nerve or cutting an artery) due to lack of depth perception.
Based upon experience obtained at existing installations and a study at the University of Surrey Hospital (MATTU) using Solid-Look systems, Solid-Look believes that its EndoStereoVision Systems, upon FDA clearance, should increase operating room efficiency, improve clinical outcomes, broaden the range of procedures that can benefit from MIS, and reduce errors that cause injury to patients.
Critical to its further success is Food and Drug Administration 510k clearance for the Solid-Look EndoStereoVision complete System. Solid-Look can obtain 510K clearance in the shortest amount of time because is using comparable devices that have previously been FDA cleared. In Solid-Look's opinion there is more than adequate predicate devices clearance history for each of the EndoStereoVision System components. As a result, Solid-Look is confident that its EndoStereoVision product will receive FDA 510K clearance shortly after funding.
The contrast provided by the EndoStereoVision system's high resolution, clear and bright three dimensional imaging when compared with existing two dimensional viewing systems has stimulated domestic and international requests from existing and potential users for incorporation of Solid-Look technology into standalone MIS systems.