Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as a Field Expedient System for Patients with Severe Torso Hemorrhage-Research and Development
Request for Information (RFI)
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) as a Field Expedient System for Patients with Severe Torso Hemorrhage
SYNOPSIS
This is a Request for Information (RFI) for planning purposes only, as defined in Federal Acquisition Regulation (FAR) 15.201e. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Government will NOT pay for information and materials received in response to this RFI and is no way obligated by the information received. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified performer sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; and universities and educational institutions, (3) their size classification relative to the North American Industry Classification System (NAICS) Code for the proposed acquisition. The applicable NAICS Code is 541712 - Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology). Your responses to the information requested will assist the Government in determining the appropriate acquisition method for the advanced development of a field deployable, rescuscitative endovascular balloon occlusion of the aorta (REBOA) system as a FDA-approved indication for the treatment of trauma-related severe hemorrhage.
BACKGROUND
Severe hemorrhage, particularly non-compressible torso and junctional hemorrhage, continues to be the leading cause of US deaths in combat. The US Army Medical Research and Materiel Command (USAMRMC) Joint Program Committee Six (JPC-6) has a requirement to develop novel strategies to control severe hemorrhage on the battlefield. Recent advancements in endovascular technology have led JPC-6 researchers to reexamine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) as a technique for controlling torso hemorrhage in austere combat environments and as an alternative to less field-expedient techniques such as thoracotomy and aortic cross clamping. JPC-6 therefore seeks Phase I-III clinical research support for the advanced development of a FDA-approved, trauma-specific indication for REBOA in a field deployable system. Although REBOA is currently performed utilizing existing catheters and commercial off-the-shelf products, the Government seeks a new device with particular military specifications and label indication for trauma that will allow for better operational adaptability and use in austere environments. The anticipated period of performance is 36 months, although this is subject to change given the variable nature of FDA submissions.
OBJECTIVES
The objective of issuing this RFI is to gather information that will assist in the determination of a suitable acquisition solution for conducting a GCP compliant clinical trial in the development of a FDA-approved, trauma-specific REBOA system for the treatment of severe hemorrhage - especially non-compressible torso and junctional hemorrhage - as experienced during combat. It is anticipated that this will be a full solution effort, spanning from final engineering, FDA submission preparation, and clinical trials to FDA approval and development of production capabilities. Interested parties should provide detailed responses and/or materials related to their technical capabilities to fulfill the potential Government requirement.
The REBOA system shall be designed to control hemorrhage from non-compressible injuries while maintaining vital blood pressure and circulation to the brain and heart. Whereas current REBOA techniques rely on existing catheters and commercial off-the-shelf products and limit military use, the Government requires a new, field deployable device that is indicated for use in trauma and has potential for point-of-injury care in austere combat environments. Specific device criteria include:
Fluoroscopy-independent placement of balloon catheter.
Minimization of time needed to place catheter.
Low-profile/small sheath size.
Integrated arterial pressure monitoring, allowing operator to monitor blood pressure above and below the balloon.
Minimization of device weight and volume.
Safeguards against balloon overinflation and inadvertent vessel perforation.
Ruggedization of device to withstand field conditions and maximize protection against patient infection.
Respondents are invited to provide materials related to their capabilities to fulfill ANY OR ALL of the inquiries listed above. Respondents should provide responses whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm.
SUBMISSION INSTRUCTIONS
All written responses must be received by January 21, 2015 at 3:00 PM EST. Submissions should: (1) use Microsoft Word or Adobe Portable Document Format (PDF); (2) be sent to Shawn Haubner at shawn.p.haubner.civ@mail.mil ; (3) be minimum 11 font on 8.5 quote mark X 11 quote mark paper; (4) be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (5) include a single organization point of contact with name, title, address, telephone and fax numbers, and e-mail address(es); and (6) not exceed 15 single sided pages in total (not including cover page and cover letter). Material that is advertisement only in nature is not desired. The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary and will be protected if appropriately marked. Do not use Government Security classification markings. Responses should include patent rights and/or licensure information for any data, product or technology that may be used to accomplish a proposed solution. Please indicate preference as to whether or not any future development rights would be shared with the Government if a partnership were to develop. Questions regarding this RFI should be submitted to Shawn Haubner at shawn.p.haubner.civ@mail.mil no later than 24 hours prior to the end date.
DISCLAIMER AND IMPORTANT NOTES
The Government will not pay for any information submitted in response hereto. Responders are solely responsible for all expenses associated with responding to this RFI. This notice does not obligate the Government to issue a solicitation or to award a contract. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to the respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation which may be published in the future.
POINT OF CONTACT
Mr. Shawn Haubner
Contract Specialist
Army Contracting Command-Aberdeen Proving Ground-Natick Contracting Division, 100 Medway Rd, Milford, MA 01757
shawn.p.haubner.civ@mail.mil
Shawn Haubner, 508-233-6167
ACC-APG - Natick (SPS)
