Vårdpersonal

Freezor

Cardiac CryoAblation Catheter

Indications, Safety, and Warnings

Indications

The 7 Fr Freezor Cardiac CryoAblation Catheter and CryoConsole System and related accessories are indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT).

Contraindications

This device is contraindicated in patients with active systemic infection, where manipulation of the catheter would be unsafe (e.g., intracardiac mural thrombus) and in patients with cryoglobulinemia.

Warnings/Precautions

The impact of cryomapping with respect to patient outcomes has not been fully characterized. The Freezor Catheter contains pressurized refrigerant during operation. Release of this gas into the circulatory system due to equipment failure or misuse could result in gas embolism. If an unanticipated event occurs, stop the procedure at any time by pushing the RED button on the console control panel. Do not pull on the Freezor Catheter, umbilicals or CryoAblation Console while the catheter tip is frozen to the endocardial tissue, as this could lead to cardiac or vascular damage. Do not connect the Freezor Catheter to any radiofrequency generator or use the Freezor Catheter to deliver RF ablation energy, because this could cause catheter malfunction and/or patient harm. Do not re-sterilize or re-use any Freezor Catheter or sterile accessory under any circumstances. Freezor Catheters and sterile accessories are designed for single use only. Do not attempt to operate the 7 Fr Freezor Cardiac CryoAblation Catheter prior to reading and understanding the Instructions for Use.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.