66--SMART SENSE AND STIM LEADS
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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.
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