65--Intent to Sole Source 506-18-2-984-0697- ICast Stents

Notice of Intent to Sole Source Requirement The Department of Veterans Affairs, VA Healthcare System, VISN 10, Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 6.302-1, Only One Responsible Source for the following items listed below. The associated NAICS code for these Supplies is 339112. The vendor, Getinge USA Sales, LLC, 45 Barbour Pond Drive, Wayne, NJ 07470-2094. Description of equipment requirements: One Each, iCast Covered Stents (MPN): 85407, and One Each, iCast Covered Stent (MPN): 85417. A firm fixed price contract with no option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This is not a Request for Proposal; this is a Notice of Intent to Sole Source requirement. 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-6158 Contracting Activity: Department of Veterans Affairs, VISN 10, Station 506, Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105-2303. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The estimated amount of this procurement is $5,550.00, which has been certified on Purchase Request No.: 506-18-2-984-0697 to purchase One (1) Each, iCast Covered Stents (MPN): 85407, One (1) Each, iCast Covered Stents (MPN): 85407. These stents are used during scheduled surgical procedures. This item will be purchased from Getinge USA Sales, LLC, 45 Barbour Pond Drive, Wayne, NJ 07470- 2094. The item is required to be delivered on or before March 13, 2018 Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Atrium s iCAST balloon expandable covered stent is FDA 510(k) cleared for the treatment of tracheobronchial strictures. The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. The iCAST stent is crafted using Atrium s PTFE encapsulation technology and a one-step deployment technique for precise, accurate deployment. The ultra-thin iCAST covered stent utilizes the latest developments in PTFE film lamination technology. Atrium s Film-Cast Encapsulation Technology protects the 316L stainless steel struts from contacting the luminal wall and is designed to expand uniformly to prevent tissue from prolapsing through the expanded stent. The patented film cast covering also helps evenly distribute radial expansion stress during balloon deployment, creating a more uniform deployment. The iCAST covered stent has a low crossing profile. Low profile means efficient delivery. These items are proprietary to Getinge USA, Sales, LLC. Formerly known as Maquet. The physician has chosen the stent being ordered during his consultation and determined this is the only product deemed appropriate for use in this specific medical situation. 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.