SOW - Pulsed Field Ablation System.docx

STATEMENT OF WORK (SOW)

Electrophysiology Pulsed Field Ablation (PFA) System

The Salt Lake City Veterans Health Care System Electrophysiology lab (EP Lab) currently uses radiofrequency (RF) ablation technology for atrial fibrillation (AF) ablations. This technology has been in use for decades and was the standard of practice throughout this time. However, recent technological advances have moved pulsed field (PFA) ablation technology to the forefront of ablative treatment for AF. PFA offers several clinical advantages over RF ablations, such as decreasing procedural time which reduces complications associated with duration of anesthesia and operative patient positioning. The cardiology department EP physicians are requesting the purchase of the Boston Scientific Farapulse PFA ablation system.

Description of Work Pulsed Field Ablation (PFA) is a non-thermal, minimally invasive cardiac procedure that treats arrhythmias like AFib by delivering high-voltage, microsecond-duration electrical pulses to create irreversible electroporation (cell death). It targets specific cardiac tissue, creating precise lesions that block faulty electrical signals while minimizing injury to surrounding tissues, such as the esophagus or phrenic nerve. Ablation System: Uses a specialized catheter—often a balloon or multi-electrode array—inserted via a vein in the groin up to the heart. Generator: Emits rapid, short-burst, high-voltage electric fields. Mechanism (Irreversible Electroporation - IRE): The energy creates microscopic, permanent pores in the cardiac cell membranes, leading to cell death without using excessive heat (radiofrequency) or cold (cryoablation). The procedure is performed under general anesthesia or sedation, with fluoroscopy and 3D mapping for guidance. A catheter is inserted through a small puncture in the femoral vein and directed into the left atrium. The physician positions the catheter around the pulmonary veins (or other targets), delivering rapid bursts of energy, often taking less than two hours. Tissue is rendered electrically silent, with reduced risk of damage to surrounding structures and faster recovery times compared to thermal methods.

Salient Characteristics

· Electroporation: a method of causing cell death in which a strong electric field creates mechanical holes, micropores, in the cell membrane – destabilizing the cell membrane while keeping the extracellular matrix intact. This pore formation does not have the same stages of nonconductivity you already expect from thermal based ablation technologies.

· To achieve durable cell death and loss of conductivity, energy must be applied to the point where the pores across the cell membrane reach stage 4 – irreversible electroporation. With the FARAWAVE catheter, this is functionally achieved through 8 total applications of 2.5 seconds in duration in a prescriptive dosing protocol.

· PFA (Pulsed Field Ablation)- tissue selective technology that allows for specific targeting of cardiomyocytes while avoiding injury to surrounding tissue.

· PFA technology that does not require forced contact to cause lesion formation.

· Non-thermal ablation modality based on the process of irreversible electroporation (IRE)

· Tissue-Selective Non-Thermal Mechanism: PFA kills cardiomyocytes by creating nanoscale pores in cell membranes (irreversible electroporation) rather than relying on heat (RF) or cold (Cryo). This selectivity spares neighboring tissues like the esophagus, nerves, and blood vessels, lowering the risk of major complications.

· Rapid, "Single-Shot" Delivery: Lesions are formed in milliseconds, rather than seconds or minutes. Multi-electrode, compliant catheters (like splined baskets) allow for complex atrial anatomies to be treated with a single pulse train.

· Increased Safety Profile: Clinical registries (e.g., MANIFEST-17K) show a <1% major complication rate, significantly reducing risks like atrio-esophageal fistula or phrenic nerve palsy.

· Biphasic Waveforms: Most clinical PFA systems (like FARAPULSE) use biphasic, microsecond-scale pulses, which reduce musculoskeletal contraction (patient movement) and microbubble formation compared to monophasic pulses.

· Enhanced Efficiency: The ability to rapidly isolate pulmonary veins makes procedures faster (often under 90 minutes total), allowing for shorter procedural times than conventional energy sources.

· Components: The system typically includes a specialized generator, a catheter interface box, and specialized catheters capable of creating 3D, non-thermal lesions.

· PFA is increasingly considered a potential new standard of care for atrial fibrillation (AFib) ablation.

Scope of Work The contractor will have the requested products delivered to Cardiology, 2nd Floor, VHASLC at 500 Foothill Drive Salt Lake City UT, 84148. Prior to implementation of the system for use, the vendor, Boston Scientific, will provide training on the generator and disposable supplies as a system to all cardiology staff members/procedure team members who will be participating in the Pulsed Field Ablation procedures. Biomedical engineering staff will be provided with any necessary training on the PFA system generator for any maintenance or repair needs.

Items to be purchased.

· FARASTAR Pulsed Field Ablation Generator Package – UPN: M004PF61M401

· Disposable catheter kits will be approved for purchase through CPRC #370290

· Extended Warranty Plan (Product Serial Number Unavailable: TBD at time of shipment)

· Training Hours/Training Plan for all Cardiology and Biomed Staff members utilizing and/or maintaining this equipment.

The C&A requirements do not apply. A Security Accreditation Package is not required.

END OF STATEMENT OF WORK