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6515--Aortic Valve (VA-22-00083943)

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36C24722Q0888Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Department of Veterans Affairs, Veterans Integrated Service Network (VISN 7) at the Ralph H. Johnson VA Medical Center intends to award a sole source contract for the procurement of the Inspiris Resilia Aortic Valve. This specialized heart valve, used in aortic valve replacement surgeries, offers unique advantages such as enabling safer and more precise valve-in-valve transcatheter aortic valve replacement (TAVR) procedures, which are commonly employed when replacing a failed bioprosthetic valve after 10 to 15 years. The valve is FDA-approved, and the sole source justification is based on the fact that only Edwards LifeSciences can meet the government's specific requirements for this product. The anticipated contract will be firm-fixed-price and performed at the Birmingham VA Medical Center in Alabama. The contract action follows FAR regulations allowing sole source awards when only one responsible source exists. This notice serves as an informational announcement rather than a solicitation, with no request for competitive proposals. Interested parties must demonstrate compelling reasons why competition would benefit the government by submitting capability statements by the specified deadline. The contracting officer managing this action is Darius Crane, who is the sole contact for communications regarding this contract.

General Info

Sole source contract for FDA-approved Inspiris Resilia Aortic Valve at Birmingham VA Medical Center.

Agency

Department Of Veterans Affairs → 247-NETWORK Contract Office 7 (36C247)

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Set-Aside

NONE

Documents

36C24722Q0888 - Aortic Valve Notice of Intent to Sole Source

sources-sought

Low

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Uniform Contract Format

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Timeline

PostedJul 19

special-notice

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Organization & Contact Information

AgencyDepartment Of Veterans Affairs → 247-NETWORK Contract Office 7 (36C247)

Contacts1 person available

OfficeAUGUSTA, GA, 30904, USA

Organization / AgencyDepartment Of Veterans Affairs → 247-NETWORK Contract Office 7 (36C247)

Office AddressAUGUSTA, GA, 30904, USA

Contacts

Darius CraneContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

Special Notice Special Notice Page 2 of 2 Special Notice *= Required Field Special Notice Page 1 of 2 NOTICE OF INTENT TO SOLE SOURCE The Department of Veterans Affairs Veterans Integrated Service Network (VISN 7), Ralph H. Johnson VA Medical Center is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a Sole Source award IAW FAR 13.106-1(b)(1) and only one responsible source and no other supplies or services will satisfy agency requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1. The NAICS code is 339113 with a small business size standard of 1,000. The VA intends to solicit and negotiate with Edwards LifeSciences. The place of performance is Birmingham VAMC, 700 19th Street South, Birmingham, AL 35233. The unique characteristic for the Inspiris Resilia Aortic Valve lies in the construction of the product. The Inspiris Resilia Aortic Valve is used in heart valve replacement surgery that involves replacement of a patient s aortic valve. The advantages of the Inspiris Resilia Aortic Valve are it allows for a safer and more precise placement of a transaortic aortic prosthesis (TAVR, valve-in-valve procedure) when a failed Inspiris valve requires replacement after 10-15 years of use. Valve-in-valve TAVR has rapidly become the most common way to manage patients with a failed bioprosthesis. It is also approved by the FDA. This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made based on unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government. The Government anticipates the award of a firm-fixed- price contract. All Interested parties who are responsible, certified, and capable may express their interest by providing a capabilities statement NLT July 26, 2022, at 2:00 PM EST. The point of contact for this action is Contracting Officer, Darius Crane who can be reached at: contact@example.gov.