Device Dossier
Nykanen RF Wire - Electrosurgical system electrode, active, general-purpose, single-use
Device Dossier for Nykanen RF Wire - Electrosurgical system electrode, active, general-purpose, single-use (Electrosurgical system electrode, active,…
Intended purpose
The Nykanen Radiofrequency Wire is intended to create an atrial septal defect in the heart.
Functional description
The Nykanen Radiofrequency Wire delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and an external electrode. The wire is usually inserted into the femoral vein and positioned into the appropriate chamber of the heart under fluoroscopy. Once positioned RF power is delivered resulting in the puncture of the targeted cardiac tissue.