Impella Heart Pump and Controller

Notice of Intent to Sole Source 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), due to only one source being available to meet the Government's needs, to Abiomed, Inc. located at 22 Cherry Hill Dr., Danvers, MA 01923-2575. Requirement is for purchase of two (2) Impella RP Heart Pump Set and one (1) Impella Controller. The Impella RP heart pump delivers blood from the inlet area, which sits in the inferior vena cava, through the cannula to the outlet opening near the tip of the catheter in the pulmonary artery. The heart pump can be implanted in the right side of the heart without open heart surgery to help pump blood in patients who need short-term support. This pump system is used to assist the right ventricle in pumping blood throughout the body. Its purpose is to prevent episode of unstable heart function, including unstable blood pressure and poor blood circulation in patients who are at high risk for its occurrence due to temporary abnormalities in heart function. The Automated Impella Controller is the primary user control interface for the Impella platform featuring a 10-inch high-resolution display; delivers real time critical care information; transportation capable with durable and secure cart; autoflow single touch activation; boost setting delivers maximum support; direct dial-in flow capability for weaning. The Automated Impella Controller controls the Impella catheter performance, monitors for alarms, and displays real-time hemodynamic and catheter position information. Abiomed, Inc. is the only manufacturer and sole provider that can provide these salient characteristics above. The Impella RP system is the first and only percutaneous heart pump FDA approved for right heart support. Abiomed's Impella Heart Pumps provides right ventricular unloading with 4.0+L/min of continuous flow for immediate improvement in hemodynamic performance. Indicated for use for up to 14 days and enables biventricular support. 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 12:00 PM Local Time, 18 April 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: contact@example.gov. NO TELEPHONE REQUESTS WILL BE HONORED