36C24418Q9821-002.pdf

Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1

For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C244-18-AP-0504

1. Contracting Activity: Department of Veterans Affairs, VISN 04, 642 Corporal Michael J. Crescenz VA

Medical Center. Contracting office NC04, 642-18-3-315-0212. BRAND NAME

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The CVX-300 is an excimer laser system used in minimally invasive interventional procedures within the cardiovascular system. The CVX-300 is unique because it emits strong pulses of light in the UV spectrum which is delivered to the targeted site with proprietary fiber optic catheter technology.

The excimer laser system will allow the Interventional Radiology department to start offering Atherectomy for patients with Peripheral Arterial Disease (PAD). Atherectomy is a procedure in which plaque is removed from the inside of a blood vessel. This is going to help provide better outcomes for our Veterans with PAD. This procedure is often a last resort for patients before having to be referred and go through major surgery/amputation. This equipment could potentially restore blood flow to major extremities preventing amputations. A price quote was obtained and the estimated amount for this procurement is $249,000.00. This a Brand Name Requirement.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Spectranetics manufactures and markets the only excimer laser system and disposable catheters for the treatment of Peripheral and Coronary Arterial Disease.

Spectranetics CVX-300 Excimer Laser facilitates photoablation through a variety of Spectranetics catheters to remove the binding of arterial plaques. Photoablation is the use of light to break down, vaporize, and remove the plaque. This is the only system on the market that can do this procedure.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted for this procurement via internet and subject matter experts.

Through the internet research conducted, it is determined that Spectranetics is the only company that manufactures and markets an excimer laser system for the treatment of Peripheral and Coronary Arterial disease. The CVX-300 excimer laser system allows for more functionality in IR and allows us to do the types of studies for the betterment of our Veterans. CO posted a Sources Sought on FBO with 2 SDVOSB responses who are capable of providing.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

____________________________ ___9-14-18 _____________ Name: Ronald J. Kline Date Title: CO

Name: Dianne Smith Date Title: NCO4, Division Chief https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466