CryoCath: Studies show Arctic Front catheter highly effective in treating atrial fibrillation

By E. Janene Geiss

Philadelphia, Jan. 17 - CryoCath Technologies Inc. said Tuesday that results from feasibility studies show the company's proprietary Arctic Front catheter is a highly effective and safe way to treat atrial fibrillation.

The 12-month data from the original 20-patient European trial saw 84% of patients atrial fibrillation-free. A further 10% or 2 more patients had significant reductions in atrial fibrillation burden and have conditions that do not warrant retreatment and are considered clinically successful, according to a company news release.

In addition, early data from 15 patients treated in the feasibility stage of the trial who have now reached a minimum three-month follow up point had 13 patients that were atrial fibrillation free, or 87%, one has been retreated and one other is scheduled to be retreated, officials said.

There were no reported permanent serious device-related adverse events such as stenosis, stroke, esophageal fistula or permanent phrenic nerve injury, officials said.

The feasibility stage of the study has enrolled 15 patients in total at the Mayo Clinic in Rochester, Minn., and Massachusetts General Hospital in Boston, officials said.

These results were presented by Douglas Packer from the Mayo Clinic at the annual International Boston Atrial Fibrillation Symposium, the only global conference focused solely on the treatment of atrial fibrillation, officials said.

"The data presented at this conference is consistent with what we've already seen in Europe. It shows unprecedented efficacy, coupled with a strong safety profile," Jean-Pierre Desmarais, chief scientific officer at CryoCath, said in the release. "These results reinforce our belief that cryotherapy delivered by Arctic Front is the ideal way to treat [atrial fibrillation]."

The Arctic Front balloon catheter now is available in Europe through a controlled beta-launch. More than 75 patients have been treated there to date with a 97% acute success rate. A more extensive roll out of this product is expected in the first half of calendar 2006, officials said.

The company also said it anticipates starting the pivotal stage of the investigational device exemption study in the first quarter.

Arctic Front is the world's first balloon cryo catheter designed to treat atrial fibrillation. The size and shape of its balloon safely and quickly creates a band of non-conducting tissue. These transmural lesions block aberrant electrical signals, preventing future atrial fibrillation episodes, officials said.

CryoCath is a Montreal medical technology company that focuses on cryotherapy products to treat cardiovascular disease.

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