reviewed

Pulsed Field Ablation System (Q0941)

Waiver type - Procurement: Nonavailability

Agency: VETERANS AFFAIRS, DEPARTMENT OF (3600) • Product Service Code (PSC) : 6515 | Last Modified: 11/08/2024

Procurement Summary

Pulsed Field Ablation System - Cardiac AFib Equipment that treats both paroxysmal (intermittent) and persistent atrial fibrillation (AFib).

Waiver Rationale Summary

Currently there are only two FDA approved Pulsed Field Ablation Systems on the market. Of the two FDA Approved Pulsed Field Ablation (PFA) Systems available, only Medtronic's PFA system meets the required specifications in the statement of work. Additionally, responses to the solicitation were received offering the Medtronic- PulseSelect™ pulsed field ablation system, a non-domestic product.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

NAICS

339112 - Surgical and Medical Instrument Manufacturing

Date Submitted

10/23/2024

Procurement Instrument Identifier (PIID)

36C25724P0588

Solicitation ID

36C25724Q0941

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

Instant Delivery Only

Waiver Coverage

Individual Waiver

Funding Agency

VETERANS AFFAIRS, DEPARTMENT OF