NOI - PCA-NHLBI-07088
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI), is issuing a non-competitive combined synopsis/solicitation (NOI - PCA-NHLBI-07088) to procure two (2) complete CD Leycom INCA Pressure-Volume (PV) Loop Systems. This acquisition is intended to be awarded on a sole-source basis to CD Leycom BV, as they are identified as the only commercial manufacturer worldwide offering an FDA 510(k) cleared invasive conductance-catheter-based PV loop recording system for human patients. Proposals are due June 23, 2026, at 9:00 AM EDT.
Purpose & Scope
This requirement supports the NHLBI Laboratory of Cardiovascular Intervention (LCI) SESAME clinical studies, which investigate 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). The systems are crucial for conducting research under Investigational Device Exemption (IDE) G220158.
Key Requirements
The solicitation seeks:
- Two (2) complete CD Leycom INCA PV Loop Systems, each including:
- Integrated, standalone system for acquisition, display, and analysis of clinical intra-ventricular pressure-volume loops.
- INCA hardware, touchscreen medical PC, and ConductNT analysis software.
- Trolley cart, pressure-arm catheter cable (0.5 m), and volume-arm catheter cable (2.7 m).
- Ten (10) 7F disposable PV loop catheters (0.025-inch lumen, 12 electrodes, 8 mm electrode spacing).
- Platinum Training & Support: Three (3) consecutive days of onsite Clinical Applications Specialist (CAS) installation/training, plus 8 hours of focused CAS remote support.
Contract Details
- Contract Type: Firm-fixed-price purchase order.
- Period of Performance: June 24, 2026, to August 3, 2026.
- Delivery: On or before August 1, 2026 (30 days from order placement).
Eligibility & Set-Aside
- NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing.
- Small Business Size Standard: 1,000 employees.
- Set-Aside: This requirement is not set aside for small business.
Submission & Evaluation
- Submission Deadline: June 23, 2026, at 9:00 AM EDT.
- Submission Method: Electronically to nicholas.capobianco@nih.gov.
- Required Information: Unit price, list price, shipping/handling, delivery timeframe, prompt payment discount terms, F.O.B. point, product/catalog numbers, product descriptions, UEI, TIN, and business size certification. Offerors must be registered in SAM.gov.
- Evaluation Factors: May include past performance, technical capability, special features, lifecycle, warranty, maintenance, and environmental/energy efficiency.
Additional Notes
This is a non-competitive solicitation authorized under FAR 12.603 and 41 U.S.C. 1901, based on CD Leycom BV's unique position as the sole manufacturer of FDA 510(k) cleared systems for human clinical use. Offerors claiming to be manufacturers or authorized resellers must provide specific documentation.