NOI - PCA-NHLBI-07088

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued. (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.