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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 16, 2015 FBO #4801
DOCUMENT

65 -- Heart Valve Replacement - 506-15-2-041-0487 - Justification and Approval (J&A)

Notice Date
1/14/2015
 
Notice Type
Justification and Approval (J&A)
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
Department of Veterans Affairs;Ann Arbor Healthcare System;Network 11 Contract Office;2215 Fuller Road;Ann Arbor MI 48105
 
ZIP Code
48105
 
Solicitation Number
VA25115Q0135
 
Archive Date
2/14/2015
 
Point of Contact
Kelly Poole
 
Small Business Set-Aside
N/A
 
Award Number
VA251-15-Q-0135
 
Award Date
1/15/2015
 
Description
1. PURCHASE REQUEST OR REQUISITION NUMBER: 506-15-2-041-04871A. PROJECT/TASK NUMBER 1B. ESTIMATED AMOUNT: $32,500.00 2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE: This is a request for a firm fixed price purchase order to Edwards Lifesciences (1 Edwards Way, Irvine, CA 92614) to purchase one (1) transcatheter heart valve, Saipen XT, transfermeral and direct aortic, 29mm size 3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED: Edwards Lifesciences is the only vendor that assists customers with the training process, on-site support, and hands on experience that is required when starting this process as new users of the transcatheter heart valves. This is done at no cost to the VA. Edwards has already provided five days of onsite training and support for the nursing and technical staff in the Cath Lab. They will continue to be on-site in order to assist the staff through the first 20 procedures. 4. REASON THAT SUGGESTED SOURCE IS THE ONLY SOURCE, WHICH CAN PROVIDE THE SUPPLIES OR SERVICES: Edwards Lifesciences and Medtronic are the only two manufacturers that have been iFDA approved to provide of the heart valves needed. Medtronic does not offer any of the on-site training that Edwards will be providing at no cost to the VA. Medtronic's sales model is to sell their transcatheter heart valves to clinics already experienced in this procedure. The Cath Lab has so many inexperienced staff members, so they can only use the Edwards Saipen XT heart valves as Edwards provides the training and support. 5. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED: A market study was previously completed, both GSA and open market, and it was found that there are only two FDA approved manufacturers of the transcatheter heart valves, Edwards Lifesciences and Medtronic. An intent to sole source was published to FBO, with negative responses. Further, recent contract (506A50078) for identical heart valves was completed as a sole source requirement, and the price of the valve needed is identical to the price of the heart valve on this order. s/signatures on file.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAAHCS506/VAAAHCS506/VA25115Q0135/listing.html)
 
Document(s)
Justification and Approval (J&A)
 
File Name: VA251-15-Q-0135 VA251-15-Q-0135_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1814446&FileName=VA251-15-Q-0135-001.docx)
Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1814446&FileName=VA251-15-Q-0135-001.docx

 
Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 
Record
SN03616124-W 20150116/150114234400-1b5a5800fe3b9b1e2f8a26463dfd9b88 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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