The Naval Medical Center San Diego (NMCSD) intends to award a sole source purchase order under the authority of FAR 13.106-1(b)(1)(i), due to only one source being available to meet the Government's needs, to Medtronic, Inc. 710 Medtronic PKWY, Minneapolis MN 55432-5604, for Transcatheter Aortic Valve Replacement (TAVR procedure). The following supplies and/or services are needed for TAVR procedure:

1. CoreValve/Evolut Transcatheter Aortic Valve-Qty:2
2. EnVeo Catheter Delivery System-Qty:2
3. EnVo R Compression Loading System-Qty:2
4. On-Site support during the implantation for the upcoming two (2) Transcatheter Aortic Valve Replacement (TAVR) procedures.

CoreValve must come with four (4) sizes of aortic annulus and ascending aorta diameters. The sizes are 23mm, 26mm, 29mm, and 31mm. The delivery catheter system must be compatible with 0.035-in (0.889-mm) guidewire. The distal end of the system must have an atraumatic, radiopaque tip and a capsule that covers and maintains the aortic valve in a crimpled position. Compression loading system must include inflow tube (straight tube), outflow cone, outflow cap, outflow tube (tube with flared ends), and inflow cone.

Medtronic, Inc is the only source that provides of the TAVR procedure that meets the requirements identified herein due to these supplies are patient specific and are based upon the patient's anatomy. Only Medtronic provides training of their products and on-site clinical support during TAVR procedure.

Delivery is required on the following date of surgeries:

February 26, 2016 at 0800
February 26, 2016 at 1200

This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. 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 or to proceed with a sole source purchase order.

Capability statements are due by 09:00 AM Local Time, February 22, 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: [email protected].