65--Award Notice 553-18-1-635-0093 - Cypass Stents

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under $150K VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($150K) Acquisition Plan Action ID: VA250-18-AP-0093 Contracting Activity: Department of Veterans Affairs, VISN 10, John D. Dingell, VA Medical Center, Station 553, Prosthetics (121), 4646 John R Street, Detroit, MI 48201. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The estimated amount of this procurement is $32,000.00 which has been certified on Purchase Request No.: 553-18-1-635-0093 to purchase 4 Cases, Cypass Stents (MPN): 806574003. The Cypass Stents are used during scheduled surgical procedures. This item will be purchased from Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134-2001. The item is required to be delivered on or before December 12, 2017. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The stent creates a channel for liquids to flow out from the anterior chamber of the eye, thereby reducing the intraocular pressure. The device rests in the supraciliary space between the sclera and the ciliary body. It s in the shape of a cylinder that has an entry port on one end and a series of holes throughout its body that diffuse the liquid flowing through. The size of the device and the holes within it result in a set level of pressure below which nothing happens, but beyond which the liquid begins to move through the device. The FDA has approved the CyPass Micro-Stent, a device for treatment of mild to moderate primary open-angle glaucoma that is intended to be implanted along with cataract surgery. The device will be marketed by Alcon, a division of Novartis. Alcon acquired Transcend Medical, the original developer of this technology, in February 2016. This item is proprietary to Alcon, Laboratories, Inc. Description of market research conducted and results or statement why it was not conducted: Reviewed FPDS-NG, GSA, MedSurg Online Catalogs, NAC, for vendors with similar items without success. A google search was also conducted only to provide ineffective results. There are currently no SDVOSB or VOSB organizations that are authorized to distribute this proprietary product. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ____________________________ December 6, 2017 Name: Michele R. Bartelt Date Title: Contracting Officer