JA_-_UVA_redacted_Redacted.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION (Actions NTE $650K for other than Simplified Acquisition Procedures)

(Actions over $650K, but not exceeding $12.5M must be approved by the competition advocate for the procuring activity)

1. Agency/Contracting Activity ACC-APG-Ft Detrick

2. Description of Action:

Nature: New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price Time & Materials Cost

For Hybrid Contracts, list percentage of each type of pricing:

Firm Fixed Price:

Time & Materials:

Cost:

Funds: Operations and Maintenance, Army (OMA) Other Funds: RDT&E

Fiscal Year of Funds: 2016

Name of Proposed Contractor(s):

University of Virginia 1215 Lee Street City, State, Zip:

Charlottesville, VA 22908

Phone:

3. Description of Services or Supplies:

The total estimated value of the proposed action is $639K.

Approval is requested to solicit on the basis of other than full and open competition for a new contract award to the University of Virginia for a research study to evaluate two pre hospital aortic occlusion devices to determine the accuracy, efficiency, and safety in controlling torso hemorrhage in a swine iliac junctional hemorrhage model for the Navy Medical Research Center’s (NMRC) Regenerative Medicine Department. The device will be acquired from Microvention and is to be provided to UVA to conduct the testing. This is a novel device that UVA co-designed with Microvention using their technology. Unfortunately, Microvention does not have the resources or facility to conduct the testing of the device. The anticipated Period of Performance (POP) will be a total of twenty-four (24) months. The information gained through this experimental activity will lead to refinement of the device in anticipation of a 510k application to the United States Food and Drug

J&A Control # NCD-16-54

Administration (FDA).

Traumatic hemorrhage, primarily the result of blast injuries, is the leading cause of death in active duty military service members (1 3). Although the widespread use of tourniquets has helped to reduce loss of life from severe lower extremity injury, non compressible torso hemorrhage remains a challenge with high mortality given the relative anatomic inaccessibility of this region to obtain hemorrhage control. Reports have suggested that up to 25% of hemorrhage sustained in the battlefield is potentially survivable with 50% the result of truncal trauma. Pelvic bleeding, in particular, can be severe and difficult to control, requiring advanced, upper echelon hospital based care, such as angioembolization, for definitive treatment. Because these advanced care methods and specially trained operators are at higher levels of care, mortality remain high. Unfortunately, outside of pelvic binders for pelvic fracture stabilization, which have limited success in hemorrhage control and are of no value in penetrating trauma there has been little advancement in the control of non compressible torso bleeding at the lower echelons of care.

Traditionally, early temporary control for non compressible torso hemorrhage has been limited to thoracotomy with aortic cross clamping. This technique has been reserved for moribund patients with absent or lost pulses and has an associated high morbidity and mortality. With growing interest in endovascular techniques for the management of vascular trauma the use of a resuscitative endovascular balloon occlusion of the aorta as an alternative to thoracotomy has been reported. For patients with massive pelvic or intra abdominal hemorrhage who survive transport to an advanced care facility, placement of a temporary occlusion balloon in the infra renal aorta, proximal to the aortic bifurcation, or the within the descending thoracic aorta have been used to provide time for more definitive treatment through surgical or endovascular methods. This in hospital technique provides a method to stop flow of blood below the level of the balloon until the balloon can be deflated under controlled conditions. Insertion of an occlusive balloon is less invasive than a thoracotomy and can be placed in the unstable patient. Endovascular balloon occlusion has been shown to be lifesaving and superior to thoracotomy with aortic cross clamping in civilian literature.

Placement of a temporary occlusion balloon in the aorta is performed under sterile conditions using ultrasound and fluoroscopic guidance, which requires time, skill, and bulky portable x-ray machines.

Despite the potentially life-saving nature of aortic balloon occlusion in the setting of massive torso and/or pelvic hemorrhage, current approaches for the placement these devices require fluoroscopic guidance. Fluoroscopy allows for: (i) intra-arterial injection of contrast dye to define the vascular anatomy, (ii) positioning of an aortic occlusion balloon with respect to this defined anatomy, and (iii) precise control of inflation of the device to allow for sufficient occlusion of the aorta while avoiding over-inflation that could result in rupture of the aorta secondary to balloon inflation. A technique has been published describing inflation of an aortic occlusion balloon in a trauma bay as a temporizing measure for patients with massive pelvic hemorrhage and life threatening shock, without fluoroscopic guidance. However, this approach required the expertise of a senior Interventional Radiologist to interpret subtle tactile cues reflecting appropriate balloon placement and inflation. Further, this technique was performed in a “blind” fashion and relied upon the assumption of normal vascular anatomy. In spite of the reported success with balloon occlusion placement, positioning and confirmation has required valuable time, the use of fluoroscopic imaging, and skilled experienced practitioners at higher echelons of care. Additionally, due to the size of the currently available device surgery is required to repair the arteriotomy created by the catheter. Any non-fluoroscopic approach for temporary occlusion of the aorta in the setting of hemorrhage must address: (i) positioning of the device with respect to individual patient anatomy, (ii) controlled inflation of the balloon to account for varying aorta diameters, particularly in the under-resuscitated patient, (iii) a low profile, allowing for removal of the device without surgical repair, and (iv) must account for considerations related to the need for operator training in how to safely introduce the device into the femoral artery without creation of additional vascular injury.

The potential benefits to the Government of this effort if successful are substantial. Placement of a temporary aortic occlusion device may become an effective technique for hemorrhage control at lower echelons of care [Role II facilities such as the Navy Afloat Trauma System (NATS), the Navy/Marine Corps Forward Resuscitative Surgical Systems (FRSS) or Role I settings with Independent Duty Corpsmen and Navy Special Warfare SEAL corpsmen and physicians])] if it could be adapted for quicker, easier insertion by non endovascular specialized providers. Earlier availability of this technique could allow first responders to stabilize non compressible torso bleeding until advanced care was available resulting in decreased mortality.

4. Authority: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations, but other exceptions may apply per FAR 6.3.

Actions other than simplified acquisition procedures (select one):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(1)

FAR 6.302-2: Unusual and compelling urgency, 10 USC 2304(c)(2)

FAR 6.302-5: Authorized or Required by Statute, 10 USC 2304(c)(5)

Other: insert appropriate authority here

5. Reasons for Authority Cited:

In accordance with FAR 6.302-1(a)(2)(ii)(A) and (B), only one responsible source exists for this contract for the testing of the Microvention device. The temporary occlusion balloon catheter (TOBAC) device for stabilization of massive torso hemorrhage in the field is a unique device that has no equivalent when considered against other current designs. This device addresses key issues with other devices, which chiefly include, the capability for use in a fluoroscopy free environment, provision of direct feedback concerning internal anatomic landmarks, and protection against aortic injury that may result from over-inflation of standard devices in the field. This device has emerged through joint planning and invention between Microvention, Inc. and the University of Virginia.

Microvention, Inc. possesses unique engineering and production capabilities which are critical to the design of this device. As a co-inventor of this device and academic institution with extensive vivarium and surgical capabilities, UVA is the only entity that may presently provide the applied preclinical testing of this device and is unique positioned to aid in the optimization of device design in preparation for submission of an FDA 510k application.

UVA is a large academic center, with extensive medical research capabilities.

is a co-inventor of the current device and is a clinical Interventional Radiologist within the

Department of Radiology and Medical Imaging. is also the Vice-Chair of Research for Radiology and Medical Imaging. UVA is a level I trauma center and routinely treats patients with acute aortic injury, blunt organ trauma with life threatening hemorrhage, and massive pelvic hemorrhage. has extensive experience utilizing aortic occlusion balloons for the treatment of patients with trauma as a life saving measure. Based upon this experience and in collaboration with partners at the Naval Medical Research Center and Microventions, Inc, has produced prototype designs for field-based aortic occlusion device systems for the field-based treatment of patients with massive hemorrhage from torso injuries. The devices that are the subject of the current project have emerged from these prototype design activities, and therefore UVA is the only source available.

The UVA’s is uniquely positioned to perform the preclinical studies necessary to test the two current devices and to provide the critical feedback on device optimization that will be necessary to move one of the two current devices forward to FDA 510k approval.

6. Efforts to Obtain Competition:

As there is no other entity that can perform this testing, no efforts will be made to obtain competition. A notice of intent to sole source will be posted and although it is unlikely that any other source for this effort could be identified, all interested parties shall be considered.

7. Actions to Increase Competition:

At this time, it is not the expectation of the Government to have any further follow-on requirements to this study.

8. Market Research:

Market research was conducted by , Regenerative Medicine Department at the Naval Medical Research Center (NMRC) in Silver Spring, MD. The Regenerative Medicine Department has a requirement to evaluate two novel pre-hospital aortic occlusion devices for controlling torso hemorrhage in a swine iliac junction model that meets the following requirements:

-Device can be placed without fluoroscopic guidance -Devices must be based upon balloon or elastomer-mesh designs to control device over-inflation with anatomical localization provided by a separate deployable locator mesh.

-Must already have a testable device meeting the aforementioned requirement.

-Must be able to assess device placement accuracy, precision, and hemostatic efficiency of aortic balloon occlusion systems.

-Must have the capability and infrastructure to test the in vivo effects of balloon on aortic wall.

-Must have capability to assess the effects of balloon inflation and elastomer mesh expansion on aortic wall injury, if any, by histologic evaluation.

The device design, testing, and optimization are very closely aligned activities. At present, there exists a prototype that has emerged from a device design that UVA was a key partner in creating. That prototype must now go through several iterative steps of device testing and refinement in order to arrive at a final device design that may be submitted to the FDA for approval. For this particular effort, the process of innovation towards a final device design has not yet concluded and the testing will heavily influence the steps that will be taken to refine the device to best stabilize patients with incompressible hemorrhage. This testing cannot be performed by a 3rd party with results communicated verbally or through written report. It requires hands on, manual experience by those individuals who were involved in the initial inception of the device in order to carry that process of innovation forward to completion. There are many groups that can create the swine junctional hemorrhage model proposed for the current effort. Additionally, there are many sites that have the capability for performing angiographic examinations on swine and inserting endovascular medical devices. However, there is only a single site (UVA) that can conduct the animal testing required in a manner that will allow for extraction of the necessary hands on data to allow for completion of the innovation process for this particular device.

identified UVA as the only source in the world that properly test this novel device because they co-designed it with Microvention.

Market research has determined that University of Virginia of Charlottesville, VA is the only company that has the capability in terms of infrastructure and facilities to conduct the testing of these two novel pre-hospital aortic occlusion devices for controlling torso hemorrhage in a swine iliac junction model that will subsequently be used to treat combat casualties in far forward locations.

9. Procurement History:

Previous Purchase Order(s) or Contract(s): Yes No

If "Yes", for each purchase order or contract provide:

Purchase order or contract number:

Was action competed? Yes No If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

10. Additional Information to support the justification. If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;

describe actions taken to remedy the situation.

Not applicable.

11. Technical / Requirements Certification: I certify that the supporting data under my cognizance which is included in this abbreviated J&A is accurate and complete to the best of my knowledge and belief.

Submitted By:

Position Title: Department Head, Regenerative Medicine, Naval Medical Research Center Email address:

Signature:

Date:

12. Fair and Reasonable Price Determination: As contracting officer, I hereby determine that the anticipated cost to the government for this contract action will be fair and reasonable.

Fair and reasonable determination shall be based on cost analysis of the proposed efforts, and cost realism analysis.

SIGNATURE:

NAME:

TITLE: Procuring Contracting Officer

13. Contracting Officer’s Approval: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing, I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

SIGNATURE:

NAME:

TITLE: Procuring Contracting Officer

5/24/2016