AJ13--Cardiovascular Valve Leaflet Cutter System Prototype

Regional Procurement Office (RPO) - East intends to negotiate on a sole source basis with Resolution Medical, LLC, 42 Northern Stacks Drive, Suite 200, Minneapolis, Minnesota, 55421-2973, to enter into a contract for specialized services for the San Francisco VA Healthcare system to prototype a functional catheter-based cardiovascular valve leaflet cutter. The current Leaflet Cutter System Project received Bringing Research Advancements to Veterans and Everyone (BRAVE) funding through the Technology Transfer Assistance Program (TTAP) to conduct prototyping activities, which will ultimately benefit Veteran patients of the San Francisco VAMC and nationally across the VA if the concept becomes a commercial product.

STATEMENT OF WORK (SOW)

GENERAL INFORMATION

1. Title of Requirement.

Technology Transfer Assistance Program (TTAP) Project to Prototype Cardiovascular Valve Leaflet Cutter System

2. Background.

The current Leaflet Cutter System Project received Bringing Research Advancements to Veterans and Everyone (BRAVE) funding through the TTAP to conduct prototyping activities which will ultimately benefit veteran patients of the San Francisco VA Healthcare system and nationally across the VA if the concept becomes a commercial product. The project consists of creating a functional catheter-based cardiovascular valve leaflet cutter which includes the capability to retain or retrieve the valve tissue. The catheter works in concert with a catheter-based temporary valve. A successful prototype will be used in bench studies to generate proof of concept results in support of future funding to develop the product further. Ultimately, the concept may be licensed and developed into a lifesaving product by a medical device company.

3. Scope.

The San Francisco VA Healthcare system is looking for specialized services to design and prototype devices in alignment with the mission of TTAP s BRAVE program. This purchase will include work to develop the device design, to build prototypes, and to test them.

4. Specifications.

The Leaflet Cutter system specifications are designed to outline all the TTAP BRAVE requirements. These requirements will be provided to the Point of Contact (POC)/Contracting Officer Representative (COR) before final approval. Multiple Leaflet Cutter prototypes shall be created and shall include the following characteristics:

Catheter 18-20 French delivery system built onto steerable catheter

Cut and retrieve leaflets from native valve or bioprosthetic valve

Mitral and aortic

Capable of functional testing in benchtop water bath and/or in vitro left heart model, ideally pulse duplicator

Sterilizable

Biocompatible materials

Materials and design meet applicable regulatory standards

Quality System Regulation 21 CFR Part 820

ISO 13485:2016

Budget shall not exceed $115,000.00

5. Security Requirements.

The Certification & Accreditation (authorization) requirements do not apply. A Security Accreditation Package is not required.

6. Place of Performance.

Services will be conducted at the vendor s physical address.

7. Period of Performance.

Base Period: 9/18/2023 12/31/2023

Approximately 3 months

Delivery must be before January 1, 2024

8. Delivery Location.

San Francisco VA Healthcare system

4150 Clement Street, 112 D

San Francisco, CA 94121

9. Delivery Requirements.

The Vendor shall notify the POC/COR to plan the delivery date. This notification shall be

provided at least one month prior to the vendor-anticipated delivery date. The Vendor

shall plan and coordinate with the POC/COR, Biomedical Engineering, ICU, and Logistics.

This notice of intent is not a request for competitive proposals. Any responsible sources who wish to identify their interest and capability to provide this equipment or equipment that is compatible must notify this Contracting Officer at millicent.covert@va.gov, NLT Friday, September 1, 2023, by 11:59 AM EST. Telephone responses will not be accepted. Upon receipt of the interested parties' notification, the Contracting Officer will determine whether to conduct a competitive procurement or proceed with sole source negotiations.