Catheter_single_source_justification_FBO.pdf

Single Source Justification (Simplified Acquisition)

Section A: General Contract Information

Contracting Activity: 1 SOCONS Purchase Request/

Identification Number:

Project/Program Name:

Resuscitative Endovascular Balloon Occlusion of the Aorta Catheter

(REBOA)

Item # ER7232A

Estimated Contract Cost

Total =

Section B: Description of the Supplies/Services Required

The need for a flexible catheter inserted through an introducer and into the femoral artery, maneuvering it into the aorta and inflating a balloon at its tip. This technique/ Endovascular Balloon Occlusion of the Aorta Catheter will be used in traumatic injured patients that are rapidly bleeding to death from injuries to their chest, abdomen or pelvis. This stops blood flow beyond the balloon, essentially halting any bleeding, while also stopping all blood flow distal to the balloon. The REBOA is the only FDA approved catheter of its kind that can be used outside the hospital, emergency room and clinical setting

Section C: Justification for Soliciting from a Single Source

Unique capabilities/supplies possessed by only one contractor as follows:

- Pryor Medical Devices is the sole provider and ONLY manufacture of the REBOA Catheter.

- Pryor Medical REBOA Catheter is the only FDA approved Resuscitative Endovascular Balloon Occlusion of the Aorta Catheter that can be used outside of Hospital, ER, and Clinical facilities.

- Special Operations Surgical Team (SOST) Surgeons/Emergency Physicians have received specialized REBOA Catheter placement/trauma applications training.

- Pryor Medical REBOA Catheter has great potential in stopping internal hemorrhage, increasing the chance of survivability of warriors suffering battlefield traumatic injuries

Section D: Efforts to Obtain Competition

Internet Search

- Currently, there is NO other Resuscitative Endovascular Balloon Occlusion of the Aorta Catheter that can be used during SOST missions, environments, and austere locations.

- There is NO other “FDA” Approved Resuscitative Endovascular Balloon Occlusion of the Aorta Catheter on the market.

- Market Research showed that Pryor Medical is sole provider of the ER-REBOA Catheter catalog number ER7232A

Section E: Steps to Preclude Future Single Source Awards

Through every available means, AFSOC/SG will continue to monitor market information and technical publications to determine whether any other source can meet our needs. In addition, minimum requirements for any future requirements as described herein will be shared with industry to encourage other manufacturers to begin producing similar compatible products.

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1)(SAP) that the circumstances of this contract action deem only one source is reasonably available.

Date

Typed Name and Rank/Grade of Requiring Activity CC

REBECCA W. CARTER, Lt. COL, USAF, BSC

Chief, Modernization Division

Signature of Commander

Date

Typed Name and Rank/Grade of Contracting Officer

Signature of Contracting Officer