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66--SMART SENSE AND STIM LEADS

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36C25019Q1130Federal

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The Department of Veterans Affairs, specifically the Louis Stokes Cleveland VA Medical Center, plans to enter into a sole source contract with Ardiem Medical, Inc. for the supply of Smart Sense and Stim Leads. These leads include implantable stimulation modules compatible with the iSens TM System, designed to restore sensation for amputees by providing clinical-grade, custom-manufactured components tailored to the specific dimensions of the study subject's super extremity amputation. The procurement is justified under FAR and VAAR regulations that authorize sole source awards to veteran-owned small businesses, recognizing Ardiem Medical, Inc. as the only reasonably available source for this specialized medical technology. The notice invites other interested parties to express their capability and interest by the deadline of July 19, 2019, although the decision to open the procurement to competition remains at the discretion of the Government. Responses received will inform whether a competitive solicitation is issued. No formal solicitation is currently available, and all inquiries must be sent via email to the designated contact at the VA, with specific instructions to reference the solicitation number and product name in the subject line. This approach ensures the VA can efficiently acquire this critical medical device while maintaining compliance with acquisition regulations intended to support veteran-owned businesses.

General Info

VA sole source contract with Ardiem Medical for custom implantable stimulation leads for amputees.

Agency

N/A

NAICS

334419 - Other Electronic Component Manufacturing

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

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Timeline

Posted

special-notice

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Organization & Contact Information

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AgencyN/A
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Office AddressN/A
ContactsNo contact information available

Full Description

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SPECIAL NOTICE NOTICE OF INTENT TO SOLE SOURCE Smart Sense and Stim Leads The Department of Veterans Affairs, The Louis Stokes Cleveland Department of Veteran Affairs Medical Center, 10701 East Boulevard, Cleveland, Ohio 44106 intends to solicit and negotiate with only one source under the authority of FAR 13.106, Only one source reasonably available, and VAAR 819.7008, Sole source awards to Veteran-owned small business concerns. The VA intends to solicit and negotiate with Ardiem Medical, Inc., 1125 Wayne Avenue, Indiana, PA 15701 for Smart Sense and Stim Leads. The Stim Leads are to provide implantable stimulation modules compatible with the iSens TM System that will enable restoration of sensation to human amputees. The clinical grade Smart Sense Leads are custom-designed and manufactured to dimension specific to the study s super extremity amputee subject. Other persons may identify their interest and capability to respond to this requirement by Friday, July 19, 2019 at 5PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries shall be submitted by email to Rachelle Hamer at rachelle. hamer@va. Enter 36C25019Q1130 | Smart Sense and Stim Leads in the email subject line.

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ASC SUPPLIER OPER AE AND AF DIV

POSTED

2 days ago

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in 3 days
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