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Freezor Xtra

Surgical Cardiac CryoAblation Device

Indications, Safety, and Warnings

Indications

The Freezor Xtra Surgical Cardiac CryoAblation Device and CryoConsole are intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The Freezor Xtra Surgical Cardiac CryoAblation Device freezes the target tissue and blocks the electrical conduction by creating an inflammatory response or cryo necrosis.

Contraindications

The Freezor Xtra Surgical Cardiac CryoAblation Device is contraindicated:

  • In patients with active systemic infections
  • For endocardial use as the safety and efficacy of endocardial use have not been demonstrated
  • In patients with cryoglobulinemia

Warnings/Precautions

The Freezor Xtra Surgical Cardiac CryoAblation Device contains pressurized refrigerant during operation. Release of this gas into the body due to equipment failure or misuse could result in pericardial tamponade, tissue emphysema, or other patient injury. If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the RED button on the console control panel. Do not pull on the Freezor Xtra device, umbilicals, or console while the device tip is frozen to tissue, as this could lead to inadvertent tissue damage. Do not connect the Freezor Xtra device to any radiofrequency generator or use it to deliver RF ablation energy, because this could cause device malfunction and/or patient harm. Do not resterilize or re-use any device or sterile accessory under any circumstances. Freezor Xtra and sterile accessories are designed for single use only. Do not attempt to operate the Freezor Xtra Surgical Cardiac CryoAblation Device prior to reading and understanding the Instructions for Use.