CRYOCATH INITIATES PATIENT ENROLLMENT IN ATRIAL FIBRILLATION.CryoCath Technologies Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :CYT), Montreal, has enrolled and treated its first patient in its Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) study for Atrial Fibrillation (AF). The study involves a unique "tool box" approach to treat AF using up to three different CryoCath catheters: Arctic Circler, Freezor Xtra and Freezor MAX. The study is designed to take place in two stages. In the first stage, the company will enroll up to 30 patients at three U.S. centers. Dr. Vivek Reddy of Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world in Boston, Dr. Jim Irwin of St. Joseph's Hospital St. Joseph's Hospital may refer to: In the United States:
St. at the Texas Heart Institute will participate as clinical investigators in the first stage, with Dr. Reddy acting as the principle investigator. Dr. Irwin treated the first patient enrolled in the AF study on November 12, 2003. In July 2003, St. Joseph's Hospital was also one of the first centers to use the Freezor CryoAblation System in the U.S. Since then, St. Joseph's has used the system to treat nearly 60 patients with a variety of arrhythmias, including AVNRT AVNRT Atrioventricular Nodal Reentrant Tachycardia AVNRT Atrioventricular Nodal Reentry Tachycardia AVNRT Atrioventricular Nodal Reciprocating Tachycardia , AVRT AVRT atrioventricular reciprocating tachycardia. and Atrial Tachycardia. With an average of 4 cryo-applications per vein, the initial AF study case resulted in all four pulmonary veins isolated with the Arctic Circler catheter alone. Per the protocol of the study, Freezor MAX successfully (confirmed by bi-directional block) created a flutter ablation line (6 cryo- applications) to avert an occurrence of Atrial Flutter, often present with or as a consequence of treating AF. Total procedure time for both ablation procedures was approximately 3.5 hours. "I was ecstatic with the success of this particular case and very impressed with both Arctic Circler and Freezor MAX. Moreover, the timeframe of the procedure now makes ablating AF a clinically viable option," said Dr. Jim Irwin. "Like many of my colleagues, the majority of my patients have AF, yet to date there has been no safe and effective device to address the disorder. The potential to bridge this technology gap is why I am enthusiastically participating in this important study." The company expects to expand the number of centers participating in the study. Subsequent to follow-up of the stage one patients, and based on acceptable safety and acute success rates, an additional number of patients will be enrolled in the second stage of the trial to generate the data required to submit a Pre-Marketing Approval application to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . The final protocol for the second stage will be determined early in 2004 after the FDA has issued its AF trial guidance document. "Starting the IDE study is an important development milestone which brings us closer to commercializing an AF catheter in the U.S., which will complement our surgical probe, SurgiFrost(R), which today is routinely used to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise cardiac arrhythmias including AF," said Steven G. Arless, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CryoCath. "Dr. Irwin's positive experience reflects the encouraging results we are getting across Europe with Arctic Circler and leads us to believe our AF cryoablation franchise positions CryoCath to become the dominant player in AF ablation." Tool Box Approach Arctic Circler, uniquely configured to treat AF originating in the pulmonary veins, has the ability to create curvi-linear lesions rapidly within the ostia Ostia (ŏs`tēə), ancient city of Italy, at the mouth of the Tiber. It was founded (4th cent. B.C.) as a protection for Rome, then developed (from the 1st cent. B.C.) as a Roman port, rivaling Puteoli. (openings) of the four pulmonary veins (PV). Freezor Xtra will touch up gaps, if necessary, resulting from unique PV anatomy. Freezor MAX will be used to create a flutter ablation line in all AF patients regardless if Atrial Flutter is present or not. About AF AF is a disorder of the heart characterized by rapid and chaotic beating of the atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. and is the most prevalent cardiac arrhythmia, affecting four million patients in the Western World. AF is one of the leading causes of stroke and short-term hospitalizations with 400,000 new cases annually. Despite its prevalence, there are no current, practical clinical options to effectively and safely treat AF. Catheter ablation to resolve AF's underlying cause, aberrant electrical signals originating on the left side of the heart near or within the pulmonary veins, has been restricted by safety concerns. As a result, the standard treatments for AF are limited to various costly drug regimens that offer only a palliative (non-curative) approach. About CryoCath(R) CryoCath is a medical technology company that leads the world in cryotherapy Cryotherapy Definition Cryotherapy is a technique that uses an extremely cold liquid or instrument to freeze and destroy abnormal skin cells that require removal. products to treat cardiovascular disease. With a priority focus on providing physicians with a complete solution of catheter and surgical products to treat cardiac arrhythmias, CryoCath has multiple products approved in the U.S. and across Europe. The company is developing additional products to expand its pipeline of products to treat cardiac arrhythmias and has research projects in ischemia and peripheral restenosis. For more information, visit http://www.cryocath.com or call 514/694-1212 ext. 224. |
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