Sol_75N98026Q00630.pdf

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National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q00630

NICHOLAS CAPOBIANCO

+10

000-000000

06/16/2026

06/23/2026 0900 ED

Multiple

The purpose of this NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION is to provide NHLBI with CD Leycom INCA PV

Loop Systems for SESAME Clinical

Studies.

Period of Performance: 06/24/2026 to

08/03/2026

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award

Management Maintenance (Oct 2018);

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NSN 7540-01-152-8067

75N98026Q00630 in Equal Employment Opportunity Investigations

(Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

FAR 52.212-5 Contract Terms and Conditions

Required to Implement Statutes or Executive

Orders/Commercial Products and Commercial

Services (Jan 2025)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: CD Leycom INCA Pressure-Volume Loop Systems for NHLBI SESAME Clinical Studies

(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.

(v) Description of Requirement:

The NIH, on behalf of NHLBI/DIR/Cardiovascular Branch/Laboratory of Cardiovascular Intervention, requires two (2) complete CD Leycom INCA Pressure-Volume Loop Systems to support NHLBI-sponsored human subjects research evaluating the mechanistic effect of transcatheter myotomy on ventricular compliance and diastolic function in patients with non-obstructive left ventricular hypertrophy and heart failure with preserved ejection fraction

(HFpEF). Each system shall consist of the following items (two of each item required, except disposable catheters as noted):

Item Product Code Description Qty per

System

INCA PV

Loop System 3001880

Integrated, standalone system for acquisition, display, and analysis of clinical intra-ventricular pressure-volume loops; includes INCA hardware, touchscreen medical PC, and ConductNT analysis software

Procart for INCA 4100189 Trolley cart for complete INCA system 1

INCA

Pressure Cable – 0.5 m

410019302 Pressure-arm catheter cable 1

INCA

Volume Cable – 2.7 m

410019401 Volume-arm catheter cable 1

CA-71083-

PL PV Loop Catheter

4100079 7F disposable PV loop catheter, 0.025-inch lumen, 12 electrodes, 8 mm electrode spacing 10

Platinum Training & Support

9900012 Three (3) consecutive days onsite Clinical Applications Specialist (CAS) installation/training plus 8 hours focused CAS remote support

Salient characteristics. The required system must possess all of the following salient characteristics:

1. FDA 510(k) market clearance for use in human patients.

2. Invasive conductance-catheter-based pressure-volume recording capability.

3. Support for load-independent assessment of ventricular function via inferior vena cava

(IVC) occlusion, including derivation of end-systolic elastance (Emax/Ees), diastolic compliance, and ventricular-arterial coupling.

4. Integrated, standalone hardware/software platform with validated analysis software for acquisition, display, and analysis as a single regulatory-cleared system.

5. Compatibility with 7F disposable conductance catheters bearing 12 electrodes at 8 mm electrode spacing.

(vi) Delivery Location:

System 1 — Ship to: Christopher G. Bruce, MD WellSpan Heart & Vascular Center 30 Monument Road, Suite 1100 York, PA 17493

System 2 — Ship to: Toby Rogers, MD MedStar Washington Hospital Center 110 Irving Street Washington, DC 20010

Desired delivery: on or before August 1, 2026 (vendor-quoted lead time: 30 days from order placement).

(vii) [Reserved]

(viii) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition.

(ix) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) A written notice of award or acceptance of an offer, issued to the successful offeror within the time specified in the offer, shall result in a binding contract without further action by either party.

The Government reserves the right to accept any offer (or part of an offer) before the expiration date, whether or not discussions are conducted, unless a written notice of withdrawal is received prior to award.

(x) Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, with their offer.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items, applies to this acquisition.

(xiii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None.

(xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xv) Submission Requirements:

Responses must include sufficient information to demonstrate the respondent's capability to provide the required product or service. Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B. point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of a specified brand-name product must provide:

(a) Product, catalog, model, and/or part number(s); (b) Product description; (c) Documentation demonstrating that the offered item meets all required salient characteristics; (d) Quantity; (e) Estimated price or cost; (f) Shipping, handling, and/or installation charges; and (g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by 9:00 AM EDT on Tuesday, June 23, 2026 and must reference solicitation number 75N98026Q00630. Responses may be submitted electronically to nicholas.capobianco@nih.gov.

This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the Agency. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government.

mailto:nicholas.capobianco@nih.gov

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