This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on June 16, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
NOI - PCA-NHLBI-07088
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The National Institutes of Health, Office of the Director, Office of Logistics and Acquisition Operations, is issuing a non-competitive combined synopsis/solicitation under FAR 12.603 and 41 U.S.C. 1901 to award a firm-fixed-price purchase order to CD Leycom BV for two complete INCA Pressure-Volume Loop Systems, including associated accessories, disposable 7F PV loop catheters, and Platinum-level training and support. This acquisition is conducted under FAR 6.302-3(a)(2)(ii) as a brand-name sole source due to the unique technological capabilities of CD Leycom’s system, which is the only FDA 510(k)-cleared invasive conductance-catheter-based pressure-volume recording system available for human clinical use, required for the NHLBI Laboratory of Cardiovascular Intervention’s SESAME studies under IDE G220158. The systems must meet specific salient characteristics including invasive conductance-catheter-based pressure-volume recording capability and support for load-independent ventricular function assessment via the inferior vena cava. Each system includes the INCA hardware, touchscreen medical PC, ConductNT analysis software, Procart trolley, pressure and volume cables, ten disposable 7F catheters per system, and three consecutive days of onsite clinical applications specialist installation and training plus eight hours of remote support. The delivery schedule specifies FOB destination terms with one system to be delivered to Christopher G. Bruce, MD at WellSpan Heart & Vascular Center in York, PA, and the second to Toby Rogers, MD at MedStar Washington Hospital Center in Washington, D.C., with performance required between June 24, 2026, and August 3, 2026. All proposals must be submitted electronically by 9:00 AM EDT on June 23, 2026, to nicholas.capobianco@nih.gov and must reference solicitation number 75N98026Q00630. Respondents must be actively registered in SAM.gov and provide their Unique Entity Identifier, Taxpayer Identification Number, and business size certification. Price quotations must include unit price, list price, shipping and handling charges, delivery timeframe after award, F.O.B. point, prompt payment discount terms, and product or catalog numbers. Proposals must also include documentation demonstrating the offered system meets all salient characteristics, a completed FAR 52.212-3 form,
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(ii) The solicitation number is 75N98026Q00630. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a purchase order without providing for full and open competition (brand-name).
This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).
The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a firm-fixed-price purchase order on a non-competitive basis to CD Leycom BV, Asveldweg 2, 7556 BP Hengelo, The Netherlands (U.S. point of contact: Patrick Sullivan, +1 (817) 879-9670; SAM.gov UEI: JLLJMU81NKV4), for two (2) complete CD Leycom INCA Pressure-Volume (PV) Loop Systems with associated accessories, disposable 7F PV loop catheters, and Platinum-level training and support, in support of the National Heart, Lung, and Blood Institute (NHLBI) Laboratory of Cardiovascular Intervention (LCI) SESAME clinical studies conducted under Investigational Device Exemption (IDE) G220158. CD Leycom BV is the sole commercial manufacturer worldwide of an invasive conductance-catheter-based pressure-volume loop recording system holding FDA 510(k) market clearance for use in human patients; no other vendor offers an equivalent system approved for clinical human use.
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective March 13, 2026.
(iv) The associated NAICS code is 334516 ¿ Analytical Laboratory Instrument Manufacturing, and the small business size standard is 1,000 employees. This requirement is not set aside for small business.
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