Pulsed Field Ablation System

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 19 is conducting a market survey to identify potential sources for a Pulsed Field Ablation System for the Salt Lake City VA Medical Center. Issued strictly for market research and planning purposes, this Sources Sought Notice aims to determine the availability, technical capability, and socioeconomic size classifications of interested suppliers and manufacturers. The anticipated North American Industry Classification System (NAICS) code for this requirement is 334510 (Electrotherapeutic Apparatus Manufacturing). Interested companies must submit their responses, including company demographics, point of contact details, Unique Entity ID, Federal Supply Schedule (FSS) or open market status, delivery lead times, and product country of origin. Additionally, respondents must indicate their eligibility under various small business programs (such as SDVOSB, VOSB, or HUBZone) and address specific small business manufacturing and ownership criteria. To assist the government in assessing capabilities, businesses are encouraged to provide supporting documentation such as product specifications, brochures, and capability statements. Responses do not constitute formal offers and must be submitted via email to lynn.lim@va.gov by 12:00 pm MT on September 14, 2026.

This document is a standard federal solicitation provision, the Buy American Certificate (October 2022). It requires offerors to certify whether their proposed end products are domestic or foreign as part of the evaluation process under Federal Acquisition Regulation (FAR) Part 25. Specifically, the provision requires offerors to: - Certify that each proposed end product is domestic and specify if it contains a critical component. - List all foreign end products, including their country of origin. - For foreign products that do not consist primarily of iron or steel (excluding commercially available off-the-shelf items), indicate if domestic content exceeds 55 percent. - Separately list domestic end products that contain a critical component. The government will use this disclosed information to evaluate offers in compliance with the Buy American Act and FAR Part 25 guidelines.

The Salt Lake City Veterans Health Care System (VHASLC) has issued a Statement of Work to transition its Electrophysiology Lab (EP Lab) from traditional radiofrequency ablation to Pulsed Field Ablation (PFA) technology for treating atrial fibrillation. The cardiology department is requesting the procurement of the Boston Scientific Farapulse PFA ablation system, which uses non-thermal, tissue-selective irreversible electroporation (IRE) to safely target cardiomyocytes while preserving surrounding structures. The scope of the procurement includes the FARASTAR Pulsed Field Ablation Generator Package, disposable catheter kits (approved via CPRC #370290), an extended warranty plan, and comprehensive training. Boston Scientific will provide operational training for all participating cardiology and procedure team staff, as well as maintenance training for the biomedical engineering department. Deliveries will be made to the Cardiology Department on the second floor of the VHASLC facility in Salt Lake City, Utah. This procurement does not require a Security Accreditation Package, as Cybersecurity and Authorization (C&A) requirements are not applicable to this equipment.