FBO Notice Date 09/20/18
BIDS Reference Number 55
Document Type: Presolicitation
Medical, Dental & Veterinary Equipment & Supplies

Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 21702-9203

65 -- Occlusion Balloon Catheters and Catheter Convenience Kits for NAMRU-SA SOL N6264518Q0035Marciano Allan V. Diaz, Contract Specialist, Email marciano.a.diaz.civ@mail.mil- Jayme L. Fletcher, Contract Specialist, Email jayme.l.fletcher2.civ@mail.milThe 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 occludingvessels. The occlusion balloon catheters shall be capable of being inserted into the vessel via minimally invasive procedures to temporarily control hemorrhageand 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 beinginserted into a vessel via a minimally invasive procedure and fully occluding avessel. 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 thesole, authorized distributor of the ER-REBOA catheters and catheter conveniencekits, 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 requiredwork. 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 bythe due date of this notice will be considered by the Government. A request fordocumentation 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 PDFattachment to the following address: marciano.a.diaz.civ@mail.mil AND jayme.l.fletcher2.civ@mail.mil. No phone calls will be accepted.

CITE: https://www.fbo.gov/spg/DON/BUMED/N62645/N6264518Q0035/listing.html