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FBO DAILY ISSUE OF AUGUST 14, 2010 FBO #3185
DOCUMENT

65 -- Angiojet Thrombectomy System-St. Louis VAMC - Justification and Approval (J&A)

Notice Date

8/12/2010
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN 15 Contracting Office;4101 S. 4th Street Trafficway;Leavenworth KS 66048
 

ZIP Code

66048
 

Solicitation Number

VA25510RQ0494
 

Archive Date

10/10/2010
 

Point of Contact

Donald E Hannah
 

E-Mail Address

cting
 

Small Business Set-Aside

N/A
 

Award Number

VA255-P-1486
 

Award Date

8/11/2010
 

Description

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION FAR 6.302-1 and 41 U.S.C. 253(c)(1) 1.Contracting Activity: Department of Veterans Affairs Network Heartland VISN 15 4101 S. 4th St. Trafficway Leavenworth, KS 66048-5505 2.Description of Action: The proposed equipment is for the VA Medical Center, l Jefferson Barracks Drive, St. Louis, MO 63125-4199, from MEDRAD called an Angiojet Thrombectomy System. It will be needed by Vascular Surgery when they begin to use the Interventional Radiology suite to perform procedures. The machine they currently use in the cardiac cath labs will have to stay there for use by the Cardiology teams. 3.Description of Supplies or Services: The proposed action is to provide a thrombectomy system that can be used by Vascular Surgery in Interventional Radiology to remove blood clots and restore blood flow to thrombosed arteries and veins. The system needs to have the ability to be used in peripheral arteries, native coronary arteries, coronary bypass grafts and in access grafts used by patients on dialysis. The total estimated price of the proposed action is $31,277.61. 4.Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C.253(c)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1(2)"Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. 5.Rationale Supporting Use of Authority Cited Above: The AngioJet Ultra is the only thrombectomy device that is FDA approved for use in peripheral arteries, native coronary arteries, coronary bypass grafts and in access grafts used by patients on dialysis. It has a unique patented system of using a special catheter that draws the blood clot to it and delivers high pressure saline jets to fracture the blood clot and remove the fragments. This flexibility gives our surgeons the ability to treat our veterans for blood clots in all parts of the body. This product is highly specialized and no other similar product can be used for as many different procedures. This same system is being used by Vascular Surgery in the Cardiac Cath Labs where they currently perform their procedures. There has been a plan agreed upon by the executive team to allow the Vascular Surgeons to use the Interventional Radiology Suite due to increased volume in the Cardiac Cath lab that decreases the amount of time Vascular Surgery has available. To implement this plan and avoid backlogging Vascular Surgery cases as well as Cardiology cases due to lack of surgical rooms we need to acquire some pieces of equipment, such as this Angiojet, that is needed for their surgeries. Not only is the AngioJet considered the best option due to its technical advantages but there is also a need to maintain continuity with the equipment that the surgeons are acquainted with already. 6.Efforts to Obtain Competition: See Item 8 below. 7. Actions to Increase Competition: Market Research will be conducted for any future requirements to confirm if any other sources become available. 8.Market Research: The subject matter experts for this product was Vascular Surgeons, who agreed that this is the only product that is FDA approved for use in both native coronary arteries and for peripheral arteries and veins. Research on the internet verified this information from multiple different sources. It is quoted many places that the Angiojet system is the only thrombectomy device with FDA approval for use in native coronary arteries, peripheral veins and arteries, and grafts. http://www.medcompare.com/spotlight.asp?spotlightid=64 http://www.invasivecardiology.com/article/7290 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm114851.htm 9.Any other facts supporting the use of other than full and open competition: a.MEDRAD is the only manufacture of this product and sole distributor. b.No other sources will meet the needs of the St. Louis VAMC. 10.Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief. ES//Joel Sauer- Administrative Officer DIS VAMC-St. Louis Date: 8-3-10 Name Title 11.Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. __es_//Hans Lorenzini___________ Date: _8-4-2010__________ Hans Lorenzini Contracting Officer
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25510RQ0494/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA255-P-1486 VA255-P-1486_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=144866&FileName=VA255-P-1486-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=144866&FileName=VA255-P-1486-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02239143-W 20100814/100813000109-e9892ad90bd1b436b308c2920c57a1dc (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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