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CD Leycom Inca Pressure Volume Loop System

Waiver type - Procurement: Nonavailability

Agency: NATIONAL INSTITUTES OF HEALTH (7529) • Product Service Code (PSC) : 6640 | Last Modified: 06/06/2023

Procurement Summary

The NHLBI DIR Cardiovascular Branch in collaboration with Emory University Midtown Hospital needs a dedicated pressure volume system to obtain real-time pressure-volume loops to assess the impact of novel catheter interventions to measure pressure-volume loops to assess cardiovascular function in human patients and human research subjects and assess interventional therapies for structural heart disease. The sole manufacturer of the required system is CD Leycom. This procurement will be for the purchase of one(1) CD Leycom Inca Pressure Volume Loop System.

Waiver Rationale Summary

This waiver is being submitted to purchase needed laboratory equipment that is not manufactured in the United States and no domestic source is authorized to supply the needed equipment. There is no commercial alternative to this specific system. CD Leycom is the sole manufacturer of pressure-volume loop systems and catheters suitable for invasive catheterization in patients in the USA

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

No

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

06/01/2023

Procurement Instrument Identifier (PIID)

75N92023P00114

Solicitation ID

N/A

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

Between 6 months and 1 year

Waiver Coverage

Individual Waiver

Funding Agency

NATIONAL INSTITUTES OF HEALTH