36C25526Q0468.pdf
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- Pulsed Field Ablation System
- Solicitation number
- 36C25526Q0468
About this file
This is a Sources Sought announcement issued by the Department of Veterans Affairs, Network Contracting Office-15, on behalf of the Harry S. Truman VA Medical Center's Electrophysiology Department in Columbia, Missouri.
The VA seeks market research on potential vendors capable of supplying a complete Pulsed Field Ablation (PFA) system to treat atrial fibrillation and cardiac arrhythmias. The required deliverables include: one (1) PFA Generator with specific technical specifications including 120V/60Hz input voltage, articulating touch screen interface, direct technician service access, and 24/7 phone support; five (5) over-the-wire PFA Catheters with 12F shaft diameter, 31mm or 35mm distal diameter, 115cm usable length, and 20 electrodes; five (5) steerable sheaths with 74cm usable length, 13F inner diameter, unidirectional deflection capability, and radiopaque distal end; and two (2) connection cables. The system must integrate fully with CARTO Mapping System version 8.1.1.17 and be compatible with VersaCross Connect Access Solution. Delivery is required 30 days after receipt of order to Columbia, Missouri.
Interested vendors must submit written responses including company name, address, point of contact, phone/fax/email, UEI number, GSA contract information if applicable, capability statement, references with contract numbers demonstrating similar past work, product brochures with specifications, authorized OEM service provider letter, and country of manufacture. Prospective contractors must be registered in SAM.gov and complete electronic representations and certifications. Reference number 36C25526Q0468 should be included in all correspondence. The point of contact is Amanda Williams at amanda.williams16@va.gov. This announcement does not obligate the Government to award a contract.
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36C25526Q0468
This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing.
The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following:
Pulsed Field Ablation System *** See Statement of Requirement below for details ***
If this is within your capability, please respond with the information below:
• Company Name
• Address
• Point of Contact
• Phone, Fax, and Email
• UEI number
• GSA Contract (as applicable)
• Capability Statement that clearly and convincingly identifies your ability to fulfill this requirement.
• References, with contract numbers, demonstrating the successful completion of work like the work required in this Sources Sought, performed in the past.
• Brochures of products being offered, to include specifications.
• Authorized service provider letter from OEM
• Country of manufacture
Interested firms are reminded that in accordance with FAR 4.203, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.203-1(b) states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in Small Business Search at https://search.certifications.sba.gov/.
Please include reference number 36C25526Q0468 in all correspondence regarding this Sources Sought.
Point of Contact for this Sources Sought is:
amanda.williams16@va.gov Department of Veterans Affairs Network Contracting Office -15 3450 S. 4th Street Trafficway Leavenworth, KS. 66048 https://search.certifications.sba.gov/ mailto:amanda.williams16@va.gov
STATEMENT OF REQUIREMENT
Pulsed Field Ablation System
OBJECTIVE
The Harry S. Truman VA Medical Center, Electrophysiology (EP) Department, in Columbia, MO, requires one (1) Pulsed Field Ablation (PFA) system to treat atrial fibrillation and other forms of heart arrythmias. PFA uses high-energy electrical pulses to ablate targeted heart tissues to help reduce frequency of abnormal heart rhythms. PFA works through electroporation, a process during which electrical impulses create tiny holes in the cell membrane. If enough energy is applied, this can cause irreversible cell damage, which is the goal of cardiac ablation.
TECHNICAL REQUIREMENTS
1. PFA Generator
a. Input voltage 120V/60Hz
b. User Interface – Articulating Touch Screen
c. Direct Access to technician service center
d. 24/7 phone support during patient procedure
e. All software updates included
2. PFA Catheter
a. Type – Over-the wire
b. Shaft diameter – 12F
c. Distal diameter – 31mm; 35mm
d. Usable length – 115cm
e. Number of electrodes – 20
f. Guidewire compatibility – 0/0.035” diameter, 180cm minimum length
3. Steerable Sheath
a. Usable length 74cm
b. Sheath overall length 91cm
c. Inner diameter – 13F
d. Deflection – Unidirectional, 35mm reach
e. Radiopaque – distal end
f. Guidewire compatibility – Maximum diameter 0.035”
4. Additional technical requirements
a. PFA system must be capable of full integration with CARTO Mapping System.
Current version is 8.1.1.17.
b. Must be compatible with VersaCross Connect Access Solution.
DELIVERABLES
CLIN 0001 – Pulsed Field Ablation (PFA) Generator
QTY: 1 EA
• In accordance with Statement of Requirement – Technical Requirements
CLIN 0002 – PFA Catheter
QTY: 5 EA
• In accordance with Statement of Requirement – Technical Requirement
CLIN 0003 – Steerable Sheath
QTY: 5 EA
• In accordance with Statement of Requirement – Technical Requirements
• Color – Clear
CLIN 0004 – Connection Cable
QTY: 2 EA
DELIVERY SCHEDULE
30 days After Receipt of Order (ARO)
DELIVERY LOCATION
Department of Veterans Affairs Harry S. Truman Memorial Veterans Hospital 800 Hospital Drive Columbia, MO 65201
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