From rxpgnews.com
FDA Gives Clearance to Study Safety and Efficacy of New Catheter for Treatment of Atrial Fibrillation
By CryoCath Technologies Inc.
Mar 29, 2005, 19:12
CryoCath Technologies Inc., the global leader in cryotherapy products to treat cardiovascular disease, today announced it has received clearance from the United States Food and Drug Administration (FDA) to initiate an Investigational Device Exemption (IDE) study for the treatment of Atrial Fibrillation (AF). The study will see the use of two CryoCath catheters, Arctic Front(TM) to treat AF and Freezor� MAX to treat Atrial Flutter when concomitant to AF.
The initial stage of this trial will treat approximately 25 AF patients at three U.S. centers, with enrolment completed by the end of the second quarter of calendar 2005. Initial three-month follow-up data is expected to be available in the fourth quarter of calendar 2005. The trial's endpoints will be safety (stenosis) and efficacy (AF free with or without drugs).
Following discussions with the FDA, CryoCath intends to use the data from this initial stage of the trial and ongoing European data to apply for U.S. regulatory approval to commence the pivotal stage of this IDE study for the treatment of AF.
The Arctic Front catheter has been designed to overcome the three principal obstacles in providing a commercially viable ablation solution for treating AF - safety limitations, inappropriate chronic success rates and lengthy/complex procedures.
With regards to safety, all the clinical results from the prior use of cryoenergy in and around the pulmonary veins suggests that this energy source does not generate serious adverse events such as stenosis (narrowing of the vein), thrombosis (clot formation), and esophageal perforation - three complications that have been consistently reported with alternative heat-based ablation systems.
With respect to efficacy, 6-month data from a 20 patient study using Arctic Front suggests success rates well above traditional point-to-point RF ablation techniques.
With respect to simplifying the ablation of the pulmonary veins and reducing procedural times, the innovative balloon design allows the entire surface area of the encircling atrial tissue of the pulmonary vein to be ablated at one time, thereby reducing the number of lesions required.
As well, the natural contours of the catheter's balloon shape allow for simple and effective anatomical placement of the catheter balloon in the target region of the encircling atrial tissue of the pulmonary vein. As a result, procedures are expected to be completed in less than 2.5 hours (skin-to-skin).
AF, described as a rapid and chaotic quivering of the top two chambers in the heart, is the most prevalent arrhythmia, affecting more than 2 million patients in the U.S. with an annual incidence of 160,000 new cases per year. It is a leading cause of stroke and hospitalizations, and has become the most common complication of cardiovascular surgery. If left untreated, it can lead to heart failure and death.
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