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Control Number: 25-MRCO-WEST-49

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office - West (MRCO-W), Joint Base San Antonio-Fort Sam Houston, Texas

2. Description of Action: This requirement is to provide one (1) FDA approved LivaNova SenTiva Vagal Nerve Stimulator for the Operating Room Orthopedics Service, Brooke Army Medical Center (BAMC), Joint Base San Antonio (JBSA), Fort Sam Houston, Texas. This action will be accomplished via a sole source acquisition and will result in a firm-fixed price contract.

Nature: X New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number: W81K00-25-Q-A012 Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract Name or #______________ Order #_______ against a single award IDC Contract Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: X Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid (insert percentage of each contract type)

Funds: ____ Operations & Maintenance, Army (OMA) Other Funds: DHP

FY: 25

Name of Proposed Contractor(s) and Address:

LivaNova USA, Inc 100 Cyberonics Blvd Ste 600 Houston, Texas 77058-2017 Phone: 210-269-1310 Kirk Jewasko, Kirk.Jewasko@livanova.com

Brand Name Buy: X Yes No

3. Description of Services or Supplies: The LivaNova SenTiva generator vagus nerve stimulator device is a physician prescribed surgically implanted medical device selected for drug resistant epilepsy. The SenTiva implantable pulse generator is the only full body conditional MRI compatibility, non-rechargeable system on the market that mitigates seizure activity by

Control Number: 25-MRCO-WEST-49

Version – February 2017

c. The SenTiva system electronically stimulates the vagal nerve, which helps to normalize communication between the brain and vagal nerve. This device eliminates the need for multiple medications and reduces the number of active seizures.

d. Failure to award a contract to LivaNova to the provide the required device compatible with the existing equipment currently being used could jeopardize the Brooke Army Medical Center, Department of Surgery’s mission of providing accurate and timely care to its beneficiary population.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to exception 5.202(a)(13)(i) “Is for an amount not expected to exceed the simplified acquisition threshold.”

7. Market Research: Market research conducted by the customer and contract specialist via the internet identified LivaNova as the sole manufacturer and distributor of the required SenTiva generator vagus nerve stimulator.

a. A thorough search was conducted via internet websites and GSA Advantage/eLibrary. No sources were identified that could satisfy the needs of this requirement.

b. The Small Business Administration’s Dynamic Small Business Search (DSBS) https://dsbs.sba.gov/ was utilized to identify small businesses capable of fulfilling the requirements of this acquisition. DSBS was queried using NAI S Code 334510 along with key words “Nerve Stimulator.” No sources were identified capable of meeting the needs of this requirement.

c. The requiring activity conducted an informal analysis by consulting surgeons (end users) concerning their experiences and requirements over the past three years of actual historical data usage. Usage was made available using supply chain management’s materiel management information system DMLSS. LivaNova SenTiva generator vagus nerve stimulator is not available via e-commerce sources via Defense Logistics Agency’s Electronic Catalog (ECAT), Distribution and Pricing Agreements (DAPA) nor a Federal Supply Schedule (FSS) contract.

d. Historical Acquisition Information/Personal Knowledge in procuring supplies/services of this type: Since 2019, the Medical Readiness Contracting Office-West (MRCO-West), JBSA has issued five (5) contracts to LivaNova for SenTiva Generator.

Contract Number Award Date Contractor POP Total Value W81K0023P0164 5 Jul 23 LivaNova 1 Oct 23 to 30 Sep 24 $ Sole Source W81K0022P0187 19 Jul 22 LivaNova 1 Oct 22 to 30 Sep 23 $ Sole Source W81K0021P0158 21 Jun 21 LivaNova 1 Oct 21 to 30 Sep 22 $ Sole Source W81K0020P0263 4 Sep 20 LivaNova 1 Oct 20 to 30 Sep 21 $ Sole Source W81K0019P0181 1 Apr 19 LivaNova 2-APR-2019 $ RFQ issued unrestricted, only one quote received