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U.S. Department of Health and Human Services

Medical Devices

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Arctic Front® Cardiac CryoAblation Catheter - P100010

Picture of the device.This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Names:
Arctic Front® Cardiac CryoAblation Catheter (Models 2AF232 and 2AF282)
Freezor® MAX Cardiac CryoAblation Catheter (Models 239F3 and 239F5)
CryoConsole (Model 106A2)
Manual Retraction Kit (Model 20MRK)

PMA Applicant: Medtronic Cryocath LP
Address: Medtronic CryoCath LP, 16771 Chemin Ste Marie, Kirkland, Quebec, CANADA, H9H 5H3
Approval Date: December 17, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100010a.pdf

What is it? The Medtronic Cryocath Cryoablation system is intended todestroy (ablate) abnormal heart tissue to treat drug refractory paroxysmal atrial fibrillation (PAF), an intermittent abnormal heartbeat in the upper chambers of the heart that cannot be treated with medicines. The Arctic Front® Cardiac CryoAblation Catheter is a steerable, flexible plastic tube (catheter) with a balloon at its tip that expands when filled with coolant delivered from the CryoConsole, a computerized control center . The Freezor® MAX Cardiac CryoAblation Catheter is a catheter with a metal tip, rather than a balloon, to which coolant can also be delivered. The Manual Retraction Kit provides the doctor with an alternative method of removing the Arctic Front balloon catheter from the patient’s heart, if needed.

How does it work? The Arctic Front® Cardiac CryoAblation Catheter is delivered to the opening of each pulmonary vein in the heart by threading it over a guidewire from a puncture in the skin and vein at the groin. The balloon at the catheter tip is filled with pressurized liquid coolant delivered from a tank in the CryoConsole. The liquid expands to a gas that causes the tip to cool to an extremely low temperature. The balloon freezes the nearby heart tissue around the pulmonary vein, thereby blocking the abnormal electrical activity that causes PAF.

The Freezor® MAX Cardiac CryoAblation Catheter similarly creates smaller individual spots or lines of frozen tissue to stop PAF as the coolant is delivered to the catheter tip.

When is it used? The Arctic Front® Cardiac CryoAblation Catheter and CryoConsole (Arctic Front® Cryocatheter System) are used for the treatment of drug refractory PAF. The Freezor® MAX Cardiac CryoAblation Catheter is used along with the Arctic Front catheter in the treatment of drug refractory PAF in order to create smaller, “touch-up” areas of tissue ablation.

What will it accomplish? The destruction of specific areas of heart tissue will block the abnormal electrical pathways in the heart that cause atrial fibrillation. The procedure has been shown to be effective in treating symptoms related to atrial fibrillation for up to one year in approximately 70% of patients.

When should it not be used? Use of the Arctic Front® Cardiac CryoAblation Catheter is contraindicated as follows:

  • in the lower chambers of the heart.
  • in patients with active infections throughout the body
  • in conditions where the movement of the catheter within the heart would be unsafe (for example, when a blood clot is known to be attached to the inner heart wall)
  • in patients having conditions where large amounts of proteins in their blood can become non-dissolvable at low temperatures
  • in patients with one or more pulmonary vein stents

Use of the Freezor® MAX Cardiac CryoAblation Catheter is contraindicated in patients with the following conditions:

  • active infections throughout the body
  • in patients having conditions where large amounts of proteins in their blood can become non-dissolvable at low temperatures
  • conditions where the movement of the catheter within the heart would be unsafe (for example, clotted blood attached to the inner heart wall)

Additional information : Summary of Safety and Effectiveness and labeling will be available online.

Other Resources: