Device Dossier
SavvyWire Pre-Shaped Pressure Guidewire - Catheter guide wire
Device Dossier for SavvyWire Pre-Shaped Pressure Guidewire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
The SavvyWire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the SavvyWire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
Functional description
Stainless-steel guidewire with optical pressure sensor and pre-shaped spiral tip used with the OptoMonitor system for blood pressure measurement. Supplied with tip insertion tube to insert the guidewire into a catheter and a hemostasis valve to flush and equalize the pressure sensor. A PTFE sleeve covers the guidewire shaft except for two zones to allow connection of surgical pacing cables (not provided). The proximal zone also allows connection of SavvyWire to the FOIC handle (preconnected).