Brand_Name_Only_and_Sole_Source_Justification.pdf

BRAND NAME ONLY and SOLE SOURCE JUSTIFICATION

NEI is looking to purchase the Pascal Streamline 577 Photocoagulator from Topcon to replace the current Topcon Pascal Laser that is at end of life. There is a continued need for this laser for retinal surgeons to be able perform many procedures in the clinical setting. The Pascal Streamline 577 Laser system will be used by retinal surgeons to treat multiple retinal conditions in the ophthalmic clinical setting including diabetic retinopathy, macular edema, retinal vein occlusions, retinal tumors, and retinal tearing. This system also features Pattern Laser trabeculoplasty software for treatment of open-angle glaucoma. The Pascal series laser reduces the level of pain for patients in that it uses shorter laser pulse durations and less heat dispersion which reduces collateral damage to surrounding tissue. Also, no other Laser system offers a fully integrated wheel-chair accessible table, slit lamp and laser delivery system with pulse durations as low as 10 milliseconds, in addition to offering both the 532 nanometer (nm) and 577 nm Laser source. The Topcon system also features 2x2, 3x3, 4x4, and 5x5 array patterns and contains a circle pattern with "auto advance" for three concentric rings. The triple ring patterns can encapsulate a retinal tear in seconds.

The Pascal (Patterned Scanning Laser) method of photocoagulation is the result of marked improvement in ophthalmic laser industry. This scanning technology provides improved safety, precision, comfort and speed for photocoagulation procedures. The technology provides a control system that applies an electric current proportional to the desired location of a beam of light to a high speed, sensitive, limited rotation motor called a galvanometer (commonly referred to as a galvo). A scanner is a galvo with a mirror attached to it. When the current is changed, the scanner quickly steers the laser beam to the desired location. Closed loop circuits ensure that the desired position is precisely reached. In Pascal, control selections such as pattern and spot size from the graphic user interface are translated into (F, X, Y) coordinates. Three scanners deliver laser light to the retina in multi-spot patterns by controlling the x-position (X), y-position(Y) and fiber selection(F) for the placement and size of the laser beam. No other Photocoagulator Laser features three galvanometers for precise pattern generation and pulse duration control. Topcon is the sole manufacturer and distributor of the Pascal Streamline 577 Photocoagulator.

I certify that to the best of my knowledge I have investigated and found that the above reasons and explanations justify this requisition as a brand name only purchase. I am the individual who has gathered and provided this detailed information and any further questions regarding these details can be directed to my attention.

Guy Foster Chief, Clinical Service Section Clinical Operations Branch, Office of the Clinical Director, Office of the Director National Eye Institute