SAM #NOI-CC-OLAO-26-008070

NIH Sole Source Notice for Medtronic Detachable CONCERTO Coils

This notice announces the National Institutes of Health Clinical Center's intent to negotiate a sole source contract with Medtronic USA Inc. for detachable CONCERTO Coils. - Agency: National Institutes of Health, Clinical Center (NIH-CC), Department of Health and Human Services - Purpose: Procurement of detachable CONCERTO Coils for occluding internal bleeding and embolization therapy - Product details: - Coils are used to block blood flow, including for tumor ablation - Available in various diameters and shapes (micro and macro) - Designed to conform to blood vessels and minimize trauma - Sole source justification: - Only Medtronic USA Inc. is considered capable of supplying these coils - Cited statutory authority for sole source procurement - No specific part numbers or quantities provided - No attachments or additional product/service line items listed - Opportunity is not an award; it is a notice of intent to sole source - Commercial opportunity for vendors offering similar embolization coil products is limited due to sole source determination

Key Details: - OEM: Medtronic USA Inc. - Product: Detachable CONCERTO Coils - Application: Embolization and occlusion procedures - No specified period of performance, quantities, or part numbers

Description

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with the following vendor: Medtronic USA Inc.

Acquisition Background:

The purpose of this acquisition is to stop internal bleeding/ blood flow.  The coils are used to occlude internal bleeding and save life.  An alternation therapy also includes deliberate blocking of blood flow to kill a tumor. The CONCERTO COILS come in an array of various diameters, both micro and macro, and deploy into various shapes to conform and constrict the blood vessel. The Embolization and resulting Occlusion of an artery and its management require a specific and comprehensive category of products, solutions and services to enable providing a continuum of care, from patient assessment to stopping a bleed, or embolizing blood flow to ablate a tumor, these products are designed to do the job with little trauma to the vasculature in the surrounding areas/tissue, minimal complications.

The statutory authority for this sole source requirement is 41 U.S.C. 253(c) (1) as implemented by FAR 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-OLAO-26-008078) by 12:00 PM eastern standard time on 07/20/2026 to: valerie.gregorio@nih.gov.

All responses received by the closing date of this synopsis will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

NOTE: The actual soliciation number is  NOI-CC-OLAO-26-008078. SAM.gov would not let me update the solication number listed.

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