Page 1 of 3 Subject: Sources Sought, Edwards Heart Valves Consignment for VA San Francisco Healthcare System (VASFHCS), Department of Veterans Affairs, Veterans Health Administration (VHA). The purpose of this sources sought is to conduct market research to support the procurement of Edwards Heart Valves Consignment for VASFHCS. This notice serves to survey the market in an attempt to ascertain whether or not sources are capable of providing the requested services. This notice allows potential contractors/vendors to submit a non-binding statement of interest and documentation demonstrating their capability. The sources sought effort is intended to assess industry capabilities and develop/support the intended direction of acquisition planning. The Network Contracting Office (NCO 21) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 339113 Surgical Appliance and Supplies Manufacturing. This sources sought is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, or large business) relative to NAICS 339113. Responses to this notice, will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this notice are not considered adequate responses to any corresponding solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this notice. Background: The Department of Veterans Affairs is seeking vendors who can provide brand name or equal Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis with ThermaFix process*; Carpentier-Edwards PERIMOUNT Magna Mitral Ease pericardial valve with Carpentier-Edwards ThermaFix process*; Carpentier-Edwards Physio II Mitral Ring; Edwards MC3 Tricuspid Annuloplasty Ring; Edwards IMR ETLogix Mitral Annuloplasty Ring; Edwards Cosgrove Annuloplasty Ring; and Edwards Intuity Elite Rapid Deployment Aortic Valve System. The vendors must demonstrate the ability to meet all requirements for this notice. MINIMUM TECHNICAL REQUIREMENTS: Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis with ThermaFix process*- Flexible cobalt-chromium alloy stent. Three independent bovine pericardial leaflets Fabric covering stent: Polyester cloth Valve sewing ring: Silicone rubber Lower profile design specific to the aortic position. Hemodynamic stability Pericardial leaflet shape to allow for precise fit with tissue thickness measurements and tissue deflection testing to be accurately matched. Model 3300TFX features the Carpentier-Edwards ThermaFix process , which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids Storage Temperature: 10 °C to 25 °C (50-77 °F) Storage Solution: Glutaraldehyde Rinse Procedure: 500 ml (sterile physiological saline solution) x 60 seconds. Repeat once using new saline solution Elimination of up to 98% phospholipids Model 3300 TFX Magna Ease Aortic Valve Specifications (mm) 19, 21, 23, 25, 27 & 29 Carpentier-Edwards PERIMOUNT Magna Mitral Ease pericardial valve with Carpentier-Edwards ThermaFix process*- Flexible cobalt-chromium alloy stent Three independent bovine pericardial leaflets matched for thickness and elasticity to optimize stress distribution. Ultra-low profile, with reduced ventricular projection of up to 40%. Long, multi-bend handle. Wide, saddle shaped cuff. Retractable stent posts. LVOT reference markers. Single cut handle. Includes Barrel Sizer Accessory Set Includes Replica Sizer Accessory Set Model 7300 TFX Magna Mitral Ease Nominal Specifications (mm) 25, 27, 29, 31, & 33 Stent Diameter (Wireform) 25, 27, 29, 31, 31 Tissue Annulus Diameter 28, 29.5, 31.5, 33.5, 33.5 External Sewing Ring Diameter 36, 38, 40, 42, 44 Anterior Effective Profile 7, 7.5, 8, 8.5, 8.5 Carpentier-Edwards Physio II Mitral Ring- Angled holder improves visualization and line-of-sight to the mitral valve Indicated for use in patients with mitral valve insufficiency Evolves from the native D-shape to a more circular shape to accommodate the pathological changes in mitral annular dimensions Model 5200 Carpentier-Edwards Physio II Mitral Ring (mm) 24, 26, 28, 30, 32, 34, 36, 38, & 40 Edwards MC3 Tricuspid Annuloplasty Ring- Rigid ring for remodeling the tricuspid annulus Constructed of titanium alloy 3D shape mimics the tricuspid annulus, corresponds to the anatomical contour Incomplete ring to avoid the sensitive conduction system anatomy Corrects annular dilatation, increases leaflet coaptation, reinforces annular suture lines, and prevents further dilatation of the annulus Downward angle in the septal region to help reduce the stress on sutures and the risk of ring dehiscence Model 4900 Edwards MC3 Tricuspid Annuloplasty Ring (mm) 26, 28, 30, 32, 34, & 36 Edwards IMR ETLogix Mitral Annuloplasty Ring- Rigid ring for remodeling the mitral annulus in patients with Type IIIB mitral regurgitation Constructed of titanium alloy Features an asymmetric design for optimal restoration of mitral compentency in valves with mitral insufficiency Tailored reduction of the anteroposterior distance leads to increases leaflet coaptation Asymmetric design compensates for tethered P2/P3 segment Provides complete fixation of the septal-lateral dimension during the cardiac cycle Model 4100 Edwards IMR ETLogix Mitral Annuloplasty Ring (mm) 24, 26, 28, 30, 32, & 34 Edwards Cosgrove Annuloplasty Ring- Flexible ring for remodeling the mitral or tricuspid annulus Flexible band allows for natural annular movement during the cardiac cycle Adapts to the 3-dimensional contour of the annulus while providing support against recurrent dilatation Multiple band lengths accommodate different posterior leaflet dimensions for a measured plication of the mitral or tricuspid annulus Model 4600 Edwards Cosgrove-Edwards Annuloplasty Ring (mm) 26, 28, 30, 32, 34, 36 & 38 Edwards Intuity Elite Rapid Deployment Aortic Valve System- Rapid deployment aortic valve system combining proven pericardial valve technology with innovations in transcatheter heart valves Built on the proven performance and long-term durability of the Perimount valve design Low supra-annular profile facilitates use with any aortotomy and provides excellent clearance from the coronary ostia Thermafix processed tissue treatment, matched leaflets, flexible alloy wireform, stainless steel frame and textured sealing cloth help to create Excellent hemodynamic performance Delivery system provides streamlined procedures through rapid valve preparation and innovative balloon design helping to save time during procedures and streamline concomitant procedures Model 8300KITB Edwards Intuity Elite Rapid Deployment Aortic Valve (mm) 19, 21, 23, 25, & 27 INSTRUCTIONS: Submit a brief description, two-three (2-3) pages (including cover letter) that demonstrates how your company can provide the requested equipment and/or services. Provide authorized distributor memo from the manufacturer. Include past experience in providing this system to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability and your address. The above salient characteristics are a draft, and are NOT finalized. If any portions seem unclear, prohibited, and/or you are unsure about the draft description of the requirement please list your comments and/or concerns in your response so they can be addressed. PLEASE INDICATE WHETHER YOU HOLD A GSA FEDERAL-SUPPLY SCHEDULE CONTRACT THAT COVERS THIS EQUIPMENT AND/OR SERVICES AND, IF SO, THE CONTRACT NUMBER. Provide BUSINESS SIZE AND SOCIO-ECONOMIC STATUS; (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantages business (c) If disadvantages, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (e) Include the DUNS number of your firm. (f) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and/or the VetBiz Registry at http://vip.vetbiz.gov. If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry (g) link to the respondent s General Services Administration (GSA) schedule, or attached file of same, if applicable (h) citation of any current or past customers (i.e., within the past two (2) years) to include contract number, point of contact telephone number or e-mail address; and (i) other material relevant to establishing core competencies of the firm. Response is due by noon Thursday, March 9, 2017. Please submit e-mail responses to Ms. Mandy Thompson, Contract Specialist, at email address: [email protected]. Your response should include a STATEMENT OF CAPABLILITY, GSA SCHEDULE INFORMATION, PROOF OF AUTHORIZED DISTRIBUTOR/DEALER, DUNS#, BUSINESS SIZE, AND SOCIO-ECONOMIC STATUS information as explained above. Please place Attention: Edwards Heart Valve SF in the subject line of your email. This notice is to assist the VA in determining sources only. NOTE: Issuance of this notice does not constitute any obligation whatsoever on the part of the Government to procure this equipment and/or services, or to issue a solicitation, nor to notify respondents of the results of this notice. No solicitation documents exists at this time; however, in the event the acquisition strategy demonstrates that GSA is a viable option for procuring a solution, the RFQ shall be posted to GSA eBuy where only those firms who currently hold a GSA Schedule with the applicable SIN will be able to respond. The Department of Veterans Affairs is neither seeking quotes nor accepting unsolicited quotes, and responses to this notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative costs incurred in response to this RFI.

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