Occlusion Balloon Catheters and Catheter Convenience Kits for NAMRU-SA

Quotes are NOT being accepted in response to this document. This document is linked to Notice of Intent (NOI) posting #N6264518Q0035. The Naval Medical Logistics Command (NMLC) intends to award a Firm Fixed Price (FFP) contract to Combat Medical Systems, LLC, 5555 Harrisburg Industrial Park Drive, Harrisburg, NC, 28075.
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The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR Part 13.501(a), Sole Source (including brand name) acquisitions, to Combat Medical Systems, LLC, 5555 Harrisburg Industrial Park Drive, Harrisburg, NC, 28075, for an indefinite delivery, indefinite quantity (IDIQ) contract that provides for the delivery of up to 500 occlusion balloon catheters and 500 catheter convenience kits. The occlusion balloon catheters shall be capable of fully occluding vessels up to 32 mm in diameter. The occlusion balloon catheters shall also be capable of monitoring blood pressure while occluding vessels. The occlusion balloon catheters shall be capable of being inserted into the vessel via minimally invasive procedures to temporarily control hemorrhage and augment afterload in traumatic arrest and hemorrhagic shock states. These supplies are required to continue hemorrhagic shock studies on swine in order to examine the use and outcomes with REBOA as a component to augment treatment.

The Emergency Room-Resuscitative Endovascular Balloon Occlusion (ER-REBOA) catheters are the only occlusion balloon catheters on the market capable of being inserted into a vessel via a minimally invasive procedure and fully occluding a vessel. A search of the FDA website determined that Prytime Medical developed the ER-REBOA catheters and has the proprietary knowledge to manufacture the technology. Therefore, Prytime Medical is the only manufacturer that can provide ER-REBOA catheters and catheter convenience kits. Combat Medical Systems, LLC is the sole, authorized distributor of the ER-REBOA catheters and catheter convenience kits, for Prytime Medical, to the DoD and Federal Law Enforcement agencies throughout the United States. The ordering period for this IDIQ contract is anticipated to be 60 months.

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 one (1), 8.5 inch x 11 inch page 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 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 contract.

Capability statements are due by 1300 Eastern Time, 05 October 2018. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following address: marciano.a.diaz.civ@mail.mil AND jayme.l.fletcher2.civ@mail.mil. No phone calls will be accepted.

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