Impella pumps and accessories

This is a notice of intent to sole source a contract under the authority of FAR 13.106-1(b)(2), only one source being available to meet the Government’s need.  The contract is estimated for final completion by 03/31/2030.

The North American Industrial Classification System (NAICS) code for this procurement is 339112, Surgical and Medical Instrument Manufacturing, with a small business size standard of 1,000 employees.  The FSC/PSC is 6515, Medical and Surgical Instruments, Equipment, and Supplies.

The Department of Veterans Affairs intends to solicit and award a sole source contract, firm fixed price, five (5) year IDIQ, for Impella Pumps and Accessories to Geo-Med, LLC, 1525 INTERNATIONAL PKWY, STE 3071, LAKE MARY, FL 32746-7646. There are no other sources of service that will satisfy agency requirements.

The Impella heart pump is the only FDA approved, non-surgical heart pump for use during stent placement and the only device series appearing under FDA product code OZD.  No other products currently meet the necessary approvals that would allow for substitution/inclusion as equal products.  Original Equipment Manufacturer (OEM) is Abiomed, a large business who sells directly through Service-Disabled Veteran Owned Small Business (SDVOSB) distributor, Geo-Med, LLC.  

Any responsible source that feels it is capable in performing this requirement may submit a quote for the above listed items and describe and/or submit documentation to support your capabilities.  The response will be considered by the agency.  If you are not the Original Equipment Manufacturer (OEM), you must submit an authorized distributor letter signed by the OEM.  If you are not the OEM and a small business, you must indicate in your response how you will comply with limitations on subcontracting and/or the non-manufacturer rule.  Responses should be submitted to Leah Smith at leah.smith@va.gov no later than Monday, February 17th, 2025, at 11:00 AM Pacific Time to be considered.

The Government will not pay for information submitted. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition.