6515--Sources Sought Ultrasound Renal Denervation
Closed Pre-Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- 36C24625Q0621
- Agency
-
Veterans Integrated Service Network 6
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs, specifically the Network Contracting Office (NCO) 6 for Durham VA Medical Center, is conducting market research to procure a Recor Renal Denervation system, specifically the Paradise Renal Denervation System. This unique catheter-based device delivers ultrasound energy to ablate renal sympathetic nerves, offering an innovative treatment for hypertension that has demonstrated clinically meaningful improvements in patient quality of life and reduced cardiovascular hospitalizations. Potential respondents must submit detailed capabilities statements by April 9, 2025, at 10:00 AM EST to Byron.Brown4@va.gov, clearly indicating whether they are small business manufacturers or resellers. Respondents are required to provide a manufacturer authorization letter confirming their status as an authorized distributor/licensee, with failure to do so potentially resulting in disqualification. The evaluation will focus on the ability of businesses to meet the VA's specific medical device requirements, with submissions to be used strictly for market research and acquisition strategy planning.
The pre-solicitation notice is designated as a total small business set-aside, targeting manufacturers and distributors within the Electromedical and Electrotherapeutic Apparatus Manufacturing sector (NAICS 334510). The solicitation number is 36C24625Q0621, and it falls under the Product Service Code 6515 for medical and surgical instruments and equipment. While no specific award value or budget range is disclosed in the document, the notice indicates that this is a market research phase to assess potential vendor capabilities for future procurement. The government emphasizes that they will not entertain questions about the market research and will not assume any costs incurred by contractors in preparing their responses. The unique nature of the Paradise Renal Denervation System, which is currently the only FDA-approved device of its kind capable of delivering ultrasound-based hypertension treatment, suggests a specialized and potentially high-value procurement opportunity.
Notice text
The Department of Veterans Affairs, Network Contracting Office (NCO) 6 on behalf of Durham VA Medical Center is conducting Market Research through this sources sought notice to help determine the availability of qualified Businesses, capable of providing Automated Endoscope leak tester along with Endoscope Maintenance Unit, that meets, but not limited to, the following:
The Durham VAMC is currently in need of Recor Renal Denervation system. The Paradise Renal Denervation System is a catheter-based system that delivers ultrasound energy circumferentially to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves. This is the only device of its kind with the ability to treat hypertension with ultrasound. In other words, no other device exists or is FDA approved on the market to deliver this type of therapy. Patients experienced clinically meaningful improvement in quality of life and reduction of cardiovascular hospitalizations.
All respondents shall indicate/provide the following:
Whether or not they are small business manufacturers of the products they wish to offer, or if they are a reseller of a small business manufacturer.
A copy of its capabilities statement.
Failure to provide the above information may result in the potential offeror being considered incapable of meeting the VA s needs.
If the contractor can provide the above item, the contractor shall provide a letter from the manufacturer stating they are an authorized distributor/licenser of their products. Failure to submit an authorized distributor letter shall result in the product(s) potentially offered to be considered grey market and shall not be considered capable of meeting the VA s needs.
The capability statements received from this market research are for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research, and the Government will not entertain questions concerning this market research. The Government will not assume any costs incurred by the contractor in the preparation of responses. All responses shall be submitted in writing no later than April 9 ,2025, at 10AM EST to the attention of: Byron.Brown4@va.gov
Please title the subject line for all responses as: Ultrasound Renal Denervation
Files
| File | Type | Posted |
|---|---|---|
| 36C24625Q0621.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| 6515--Ultrasound Renal Denervation (RDN) System Supplies | Award Notice | |
| This notice | Pre-Solicitation |
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