6515--watchman FLX pro

Closed Pre-Solicitation Posted

Solicitation number
36C25725Q0573
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
North Texas VA Healthcare System 4500 South Lancaster Road Dallas, Texas 75216, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs Veterans Health Administration is conducting market research for the procurement of the Watchman FLX PRO, a 40mm surgical implant designed for percutaneous, transcatheter closure of the left atrial appendage. The device will be used by the North Texas (Dallas) Healthcare System and features HEMOCOAT Technology, radiopaque markers, and is intended to reduce thromboembolism risk. Interested vendors must submit responses by 11:00 AM Central Time on May 22, 2025, to the contracting officer Michelle Cunningham. The VA is specifically seeking responses from manufacturers and authorized distributors, with a strong preference for Service-Disabled Veteran-Owned Small Businesses (SDVOSB), Veteran-Owned Small Businesses (VOSB), or other small business entities. Vendors must provide comprehensive information including business details, SAM UID number, NAICS code, business size, type, OEM authorization proof, and estimated market research pricing.

The pre-solicitation notice does not currently indicate a specific set-aside designation, though the VA is evaluating potential small business opportunities. The solicitation emphasizes a preference for items manufactured in the United States, and vendors must provide proof of being an authorized distributor to ensure the VA does not receive gray market items. While no specific award value or budget range is disclosed, the market research will help determine the procurement strategy, including whether the future solicitation will be set aside for small businesses. The evaluation will consider factors such as pricing fairness, manufacturing location, and business type. The procurement is specifically for the North Texas VA Healthcare System located in Dallas, Texas, and involves a medical device with precise specifications for storage conditions and surgical application.

Notice text

This market research notice is being conducted by Network Contracting Office (NCO) 17 VHA Regional Procurement Office-West (RPOW) 124 E. 5441 Babcock Road STE 302, San Antonio, Texas 78240 for the procurement of the Watchman FLX PRO. Background and Requirement: Contractor shall provide supplies and services for the North Texas (Dallas) Healthcare System, located at 4500 S. Lancaster Rd, Dallas, Texas 75216. 1. WATCHMAN FLX PRO shall be in accordance with the original equipment manufacturer (OEM) specifications. Kind of material: The WATCHMAN FLX Pro Device is designed with three first-ever features: new HEMOCOAT Technology designed to improve the healing process, radiopaque markers for precise device placement, and a new 40mm size for larger appendages.  Dimensions, size, capacity: 40MM Principles of operation: watchman FLX Pro is intended for percutaneous, transcatheter closure of the left atrial appendage. Restrictive environmental conditions: AMBIENT STORAGE (15-25 degree Celsius) Intended use: This equipment can reduce the risk of thromboembolism End item application: Surgical Implant Other pertinent information that describes the item, material or service required: IMPLANT REPLACEMENT Where are the items manufactured at? Provide the City and State: Include this information in your response. This equipment for proposed is the WATCHMAN FLX PRO. SPECIFIC INSTRUMENT REQUIRED: North Texas (Dallas) Healthcare System, located at 4500 S. Lancaster Rd, Dallas, Texas 75216. If this is an item your business can provide, please respond to this Sources Sought Notice by 11:00 AM Central Time on Thursday, 22 May 2025. The intent of this notice is to establish sources to define the procurement strategy (e.g. set-aside, sole source, unrestricted) for a solicitation that VA intends to post soon. Interested contractors are requested to respond in accordance with the following: a. where the item is manufactured; the VA is interested in procuring items manufactured in the United States. If you have an existing GSA or VA, Federal Supply Schedule contract, include the contract details in your response. Please note that VA is particularly interested in determining the availability of Service Disable Veteran Owned Small Business/Veteran Owned Small Business or other Small Business manufacturers or authorized distributors that can provide this item. Respond to this notice if you can provide these products listed in the table in the background and requirement section above. In the response, please cite your business size status. DISTRIBUTORS: You must provide proof that you are an authorized distributor. VA does not accept gray market items. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining the procurement strategy for the future solicitation. (e.g. if CO determines that capable small businesses cannot provide fair and reasonable pricing, then the solicitation will not be set-aside). Responses should include: (1) Business Name (2) Business Address (3) Point of Contact - Name - Phone Number - E-mail Address (4) SAM UID Number (5) NAICS code (6) Business Size: SMALL or LARGE (7) Type of Business: SERVICE-DISABLED VETERAN OWNED (SDVOSB), VETERAN OWNED(VOSB), 8A, HUBZone, WOMAN-OWNED (WOSB), etc. (8) Letter stating OEM authorized dealer, authorized distributor, or authorized reseller for the proposed equipment and/or services if applicable (9) GSA/FSS Contract Number if applicable All businesses eligible to provide this item are encouraged to reply as this information may be used to determine potential set-asides for the above-noted requirement. Send responses to Michelle Cunningham at michelle.cunningham@va.gov. DISCLAIMER: THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. However, Contractors may submit a capability statement, proposal, or quotation which shall be considered by the contracting officer whether to continue with the sole source procurement or to provide for competition. Due to technical issues, please allow additional time if you re using electronic means. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government.

Files

File Type Posted
36C25725Q0573 Watchman Pro.docx DOCX document

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