GTI-00054: Galvanize Therapeutics INUMI Flex Needle for the Aliya Pulsed Electric Field System, 21G x 31mm Needle, 5mm Tip, 160cm Working Length

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| Price: | $499.00 per box of 1 |
|---|---|
| Quantity: | |
| In Stock: | 1 box of 1 |
| Status: | expired |
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Additional Details
Galvanize Therapeutics GTI-00054 INUMI Flex Needle for PFA
The Galvanize Therapeutics INUMI Flex Needle GTI-00054 is a sterile, single-use endoscopic delivery device intended for use with the Aliya PEF System for the surgical ablation of soft tissue. It passes through a compatible endoscope working channel and delivers pulsed electric field energy to targeted tissue through its monopolar electrode, supporting endoscopic access and controlled energy delivery.
Product Code: GTI-00054
- Product Type: Endoscopic soft-tissue ablation needle
- Product Family: INUMI Flex
- Compatible System: Aliya PEF System and Aliya EX System
- Energy Modality: Pulsed electric field
- Energy Delivery: Monopolar electrode
- Needle Gauge: 21 G
- Maximum Outer Shaft Diameter: 1.8 mm
- Minimum Endoscope Working Channel: 2.0 mm
- Working Length: 160 cm
- Active Tip Length: 5 mm
- Intended Use: Surgical ablation of soft tissue
- Use: Single-use
Sterilization
- Device Packaged as Sterile: Yes
- Requires Sterilization Prior to Use: No
AccessGUDID Info
- FDA Product Code: OAB
- FDA Product Code Name: Low Energy Direct Current Thermal Ablation System
- FDA Product Code: GEI
- FDA Product Code Name: Electrosurgical, Cutting & Coagulation & Accessories
- GMDN Term Code: 67470
- GMDN Term Name: Irreversible electroporation system endoscopic probe
- GMDN Term Description: A hollow, long, tubular electrical conductor with a sharply-pointed distal end intended for endoscopic introduction to deliver short electrical pulses, in a monopolar configuration, to produce irreversible cell membrane electroporation for ablation of soft tissue (excludes cardiac tissue). It is intended to be proximally connected to a connection electrode with a connection cable for use in conjunction with an appropriate generator. It may include a stylet intended to facilitate introduction; the connection electrode and connection cable are not included. This is a single-use device.
More on Ablation | PFA
Pulse Field Ablation (PFA) is an emerging non-thermal cardiac ablation technology used to treat atrial fibrillation (AFib). Unlike traditional ablation methods that use heat (radiofrequency) or cold (cryoablation) to destroy tissue, PFA delivers ultra-rapid electrical pulses that selectively target cardiac cells through a process called electroporation. This approach enables precise lesion creation while minimizing the risk of collateral damage to surrounding structures like the esophagus, phrenic nerve, or pulmonary veins. PFA is gaining interest for its potential to improve procedural safety, reduce recovery times, and offer a more efficient workflow in the electrophysiology lab.
IN-DATE