Device Dossier
TorFlex™ Transseptal Guiding Sheath - Catheter, intravascular, guiding
Device Dossier for TorFlex™ Transseptal Guiding Sheath - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston…
- GMDN category: Catheter, intravascular, guiding
Intended purpose
The TorFlex™ Transseptal Guiding Sheath kit is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
Functional description
Following vascular access using an access needle, the guidewire is introduced and advanced to the required depth. With the guidewire in place, the access needle is withdrawn. The dilator/sheath assembly is threaded over the guidewire using a slight twisting motion into the required location under fluoroscopic guidance. The sheath side port is used for the injection of fluids or to aspirate blood during the procedure or during removal of the transseptal device or dilator.