36C24E24Q0125.docx
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- Solicitation number
- 36C24E24Q0125
About this file
This document is a Special Notice from the Veterans Health Administration (VHA) Regional Procurement Office East, announcing the intent to sole source a requirement for the design and development of a Cardiovascular Valve Leaflet Cutter System prototype to Resolution Medical.
The requirement is a follow-on to a previous contract, 36C24E23P0138, which established an initial prototype. The current prototype development effort aims to create two functional catheter-based leaflet cutter systems capable of cutting and retrieving valve tissue from both native and bioprosthetic mitral and aortic valves. The prototypes must meet specified technical requirements, including an 18-20 Fr delivery system, sterilizability, biocompatibility, and regulatory compliance. The prototypes are to be delivered before September 30, 2025, and will be tested at a VA facility in San Francisco, CA.
This is a sole source procurement under FAR 6.302-1, as the agency believes Resolution Medical is the only responsible source. However, any other responsible sources who believe they can meet the requirement may submit capability statements by September 11, 2024 at 10:00 AM EST. The government will make a determination on whether to compete the requirement based on the responses received.
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Text version
Special Notice Special Notice
| SUBJECT* |
| Research Support - Prototype of Cardiovascular Valve Leaflet Cutter System. Intent to Sole Source to Resolution Medical |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 15215-1802 |
| SOLICITATION NUMBER* |
| 36C24E24Q0125 |
| RESPONSE DATE/TIME/ZONE |
| 09-11-2024 10:00 am EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 15 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| PRODUCT SERVICE CODE* |
| AJ13 |
| NAICS CODE* |
| 541715 |
| CONTRACTING OFFICE ADDRESS |
| Veterans Health Administration |
Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802
POINT OF CONTACT*
Contracting Officer Michael Haydo michael.haydo@va.gov
(412) 822-3158
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
The Veteran’s Administration (VA) Office of Research and Development, Regional Procurement Office – East in Pittsburgh, PA intends to negotiate on a sole source basis with Resolution Medical based in Minneapolis, MN on behalf of the VA San Francisco Healthcare System.
The requirement is to continue designing and developing a Leaflet Cutter System. This will be a follow-on to contract 36C24E23P0138 which set the prototype and potential to continue.
The current Leaflet Cutter System received funding to conduct prototyping activities which will ultimately benefit veteran patients if the concept becomes a 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.
Two Leaflet Cutter and Temporary Valve system prototypes are to be created and shall include the following:
· 18-20 Fr delivery system built onto steerable catheter
· Can 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
· Delivery date before September 30, 2025
· As these devices are custom built prototype, the vendor will not provide maintenance support.
The requirement will take place at a VA facility in San Francisco, CA. The sole source is pursuant to FAR 6.302-1 Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the contracting office no later than Wednesday, Sept 11, 2024, (10:00 AM, EST). Interest/capability statements may be sent to Michael Haydo at Michael.haydo@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
| *= Required Field |
| Special Notice |
Special Notice
File details come from the government source that posted it. Updated .