Mechanical heart valves

Added: Aug 20, 2013 2:01 pm The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is St. Jude Medical Inc, 1 Saint Jude Medical Dr, Saint Paul, MN 55117. Naval Medical Center San Diego (NMCSD) has a requirement for mechanical heart valves, both mitral and aortic, as well as an aortic valve graft, which consists of an aortic valve with a length of vessel graft to replace a portion of the aorta. These heart valves shall include a sewing cuff to aid in attaching the valve to the vessel.

The requirement is for the following specific mechanical heart valves manufactured by St. Jude Medical; heart valves are available only on order of a physician or otherwise licensed practitioner. These valves include the Regent aortic valve with flex cuff, the Master mitral valve, the Master HP aortic valve, and the Masters HP Valved Graft.

The product shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.

There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Brian Miller at brian.miller4@med.navy.mil. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller. Email challenges are preferred. Closing date for challenges is no later than 4:00 PM. ET on 4 Sep 2013. No phone calls will be accepted.