SAM #36C24E26Q0080

Intent to Sole Source: AtCor SphygmoCor XCEL System for Birmingham VA Medical Center Clinical Trial

This notice announces the VA's intent to award a sole source contract for a specialized medical device: - The Department of Veterans Affairs (VA), through the VHA Regional Procurement Office East, plans to procure one (1) AtCor SphygmoCor XCEL System from ATCOR Corp. - The system is a non-invasive arterial assessment platform used for measuring central (aortic) blood pressure, pulse wave analysis (PWA), and carotid femoral pulse wave velocity (PWV). - The procurement includes the electronics module, software license, brachial and femoral/thigh cuffs, carotid tonometer, air hoses, power supply, and user documentation. - The equipment is required for a multisite clinical trial (NCT06495710) funded by the VA MERIT Award, and all sites must use the same model and configuration for standardized data collection. - The SphygmoCor XCEL is described as the only FDA-cleared, commercially available system with the required proprietary features, including non-invasive central blood pressure waveform derivation, standardized augmentation index and pulse-wave analysis, and carotid femoral PWV measurements. - Only the OEM, authorized dealers, distributors, or resellers of the listed items are eligible to respond with capability statements. - The procurement is a single purchase; period of performance is not specified but equipment will be used for the duration of the clinical trial.

Description

The Department of Veterans Affairs, Birmingham Medical Center through the VHA Regional Procurement Office East intends to negotiate on a sole source basis, pursuant to Revolutionary FAR Overhaul 6.103-1, with ATCOR Corp .The requirement is the purchase of one (1) AtCor SphygmoCor XCEL System, a non-invasive arterial assessment platform used to measure central (aortic) blood pressure, pulse wave analysis (PWA), and carotid femoral pulse wave velocity (PWV). The system includes the SphygmoCor XCEL electronics module, software license, brachial and femoral/thigh cuffs, carotid tonometer, air hoses, power supply, and associated user documentation. This equipment will be deployed as part of the multisite clinical trial registered under NCT06495710 and supported by the VA MERIT Award 1I01CX002720 01A1 (Project ID 10912973). It is critical that all participating sites utilize the same equipment model and configuration to ensure standardized data acquisition across sites. The SphygmoCor XCEL provides validated clinical and research measurements of arterial stiffness, central hemodynamics, and vascular aging, supporting cardiovascular risk assessment, hypertension management, and outcomes evaluation in this trial. These data will support the study s objectives of assessing the effects of interventions on arterial stiffness and cardiovascular outcomes in Veterans. The system will be used by trained clinical and research personnel within the Cardiology Section at the Birmingham VA Medical Center. The required equipment is the AtCor SphygmoCor XCEL System, which possesses unique, proprietary capabilities that are essential for the Birmingham VA Medical Center s participation in the multisite clinical trial NCT06495710, funded through the VA MERIT Award 1I01CX002720-01A1 (Project ID 10912973). The SphygmoCor XCEL is the only FDA-cleared, commercially available system that combines: Non-invasive central (aortic) blood pressure waveform derivation using a validated brachial cuff-based algorithm; Standardized augmentation index (AIx) and pulse-wave analysis parameters used in large-scale VA and NIH studies; and Carotid femoral pulse-wave velocity (PWV) measurements obtained using AtCor s proprietary tonometer and processing algorithms, which are required endpoints in this clinical trial.

This notice of intent is not a request for competitive quotes; however, any responsible source who believes it is capable of meeting the requirement and who is the Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller of all the items listed above, may submit a capability statement to the contracting office no later than Monday August 3 2026, 2:00PM, MDT. Interest/capability statements may be sent to Robert Dobson at Robert.Dobson1@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.

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