CryoCath to expand pivotal study on atrial fibrillation

By Lisa Kerner

Erie, Pa., April 3 - CryoCath Technologies, Inc. announced that, due to a request from the Food and Drug Administration, it will expand the feasibility stage of its STOP AF trial by enrolling an estimated 15 additional patients.

The trial is assessing the company's Arctic Front catheter to treat atrial fibrillation (AF), a cardiac arrhythmia affecting more than 2.2 million Americans, according to a news release.

Patients will be treated with the latest version of CryoCath's Arctic Front bi-directional, double balloon catheter. The revised design incorporates improvements, including two balloon sizes, based on physician feedback from clinical use in Europe and the United States.

The device lets physicians rapidly isolate all four pulmonary veins and create large, durable transmural lesions that stop the incidence of AF episodes, CryoCath said.

The FDA has requested more patients be treated before the start of the pivotal portion of the U.S. trial as a result of these changes, the company said.

"While we are prepared to commence the pivotal stage of the STOP AF trial, we nonetheless understand the FDA position to have absolute certainty as to this or any other product's ultimate safety profile," chief scientific officer, Jean-Pierre Desmarais said in the release.

"The Arctic Front version to be used on these additional patients, all of whom have already been identified and lined-up for treatment, is the same version that is in commercial use in Europe and is performing well in multiple centers."

FDA feedback is expected mid-April.

CryoCath is a Montreal-based medical technology company that provides catheter and surgical products to treat cardiac arrhythmias.

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