Cardiothoracic Implants and Surgical Supplies

Notice of Intent to Award Sole Source.

The Medical Readiness Contracting Office - West, JBSA - Fort Sam Houston, Texas intends to award a Firm-Fixed-Price sole source contract to Edwards Lifesciences LLC. under the authority of Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source, for the requirement for Cardiothoracic implants and surgical supplies. This cardiac supply, specifically SAPIEN3 Transcatheter Heart Valve (THV) System and associated supplies. These products designed to treat severe aortic stenosis. The SAPIEN3 implantable Transcatheter Heart Valve is used to replace previously implanted surgical artificial aortic or mitral heart valves in patients who are too high risk for open-heart surgery. These products allow surgeons to replace failing previously implanted artificial aortic or mitral heart valves through a balloon catheter, once implanted it should improve patients’ quality of life.

The applicable NAICS code for this requirement is 339113, Surgical Appliance and Supplies Manufacturing. The Small Business Size Standard is 750 employees.  Award will be made on or after 01 May 2023.

The solicitation number is W81K0023Q0046 and is generated for the purposes of posting this notice. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. A determination by the Government not to compete the purchase order based upon responses to this notice is solely within the discretion of the Government. This notice is neither a request for quotes nor a solicitation of offers; however, interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. Questions will not be accepted after the due date. All responses must be received by 14 Mar 2023-10:00AM CST

Salient Characteristics for Edwards Lifesciences LLC Products

1. All products must be FDA approved and TAA compliant.

2. Must be clinically proven to treat severe aortic stenosis

 3. Staff surgeons must be familiar with product.

 4. Operating Room staff must be familiar with implant.

 5. Must be able to replace failing previously implanted artificial aortic or mitral heart valves through a     balloon catheter.

6. Must offer a broad range of surgical products to customize care based on patient’s needs.

7. Must be able to provide tissue with calcium blocking properties.

Contracting Office Address:

Medical Readiness Contracting Office - West

Attn: MCAA-RC, 3551 Roger Brooke Drive

JBSA-Fort Sam Houston, TX 78234-6200

Wane V. Thompson

wayne.v.thompson3.civ@health.mil