SAN DIEGO, March 10 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced today the publication of a study on the treatment of atrial fibrillation utilizing the Company's Cryoablation System. The study was published in the February 26, 2008 special focus issue of the Journal of the American College of Cardiology (JACC). The study concluded that, using the Cryoablation System, pulmonary vein isolation benefited 82% of patients with recent onset paroxysmal atrial fibrillation, or AF, during a mean follow- up averaging 33 months. This is the first and only study to be published that reviews safety and long-term efficacy of AF ablation utilizing cryotherapy, or extreme cold. The study also demonstrated an excellent safety profile with no occurrences of pulmonary vein stenosis or esophageal injury, which are two serious complications that can occur during AF ablation with radio frequency, or other heat-based, ablation devices.
The study examined the effectiveness of treating patients with early stage paroxysmal AF by isolating the pulmonary veins using the CryoCor Cryoablation System. Seventy patients with drug refractory, early stage (five years or less) symptomatic paroxysmal AF were enrolled in the study and tracked for 15 to 60 months following treatment. After the initial pulmonary vein isolation ablation procedure, 34 (49%) patients had no AF recurrences off antiarrhythmatic drugs, 15 (21%) patients had no recurrences on antiarrhythmic drugs and eight (11%) patients reported an improvement of greater than 50% while on antiarrhythmic drugs. Overall, 57 patients (82%) benefited from the procedure. Of the 13 patients that did not improve following the ablation, 10 received a second pulmonary vein isolation six months after the first procedure, with six of these patients reporting improvement in their symptoms.
Dr. Rodriguez and Dr. Timmermans, senior authors of the study, stated, "This study further validates our belief in CryoCor's Cardiac Cryoablation System as a safe and effective treatment for atrial fibrillation. This long term study is the first of its kind to follow patients for an average of almost three years, and we are very pleased with the safety and effectiveness results we continue to see with this system."
Ed Brennan, Ph.D., President and Chief Executive Officer of CryoCor, said, "We are very pleased with the atrial fibrillation study results published in the Journal of the American College of Cardiology, a highly-respected and widely-read journal. We believe this study will help to expand the awareness of our Cryoablation System among physicians in the United States, building on the recent FDA approval of the system for the treatment of right atrial flutter."
In August 2007, CryoCor announced completion of enrollment of its pivotal trial for the treatment of AF. CryoCor is the first Company to complete enrollment of a pivotal atrial fibrillation clinical trial, and anticipates filing a PMA for the treatment of AF in the second half of 2008. CryoCor believes that the study published in JACC validates the safety and effectiveness of CryoCor's Cardiac Cryoablation System for the treatment of AF.
The study was conducted by the Academic Hospital Maastricht, in Maastricht, the Netherlands; the University Hospital of Liege, in Liege, Belgium; and the Cardiovascular Research Institute Maastricht in Maastricht, the Netherlands. The authors of the study are Wendel Moreira, MD, Academic Hospital Maastricht; Randy Manusama, MD, Academic Hospital Maastricht; Carl Timmermans, MD, PhD, FACC, Academic Hospital Maastricht; Benoit Ghaye, MD, University Hospital of Liege; Suzanne Philippens, RN, Academic Hospital Maastricht; Hein J. J. Wellens, MD, PhD, FACC, Cardiovascular Research Institute Maastricht; and Luz-Maria Rodriguez, MD, PhD, FACC, Academic Hospital Maastricht.
CryoCor is a medical technology company that has developed and manufactures a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The Company's product, the CryoCor Cardiac Cryoablation System, or the Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The Cryoablation System has been approved in Europe for the treatment of atrial fibrillation, and atrial flutter, the two most common and difficult to treat arrhythmias, since 2002. In the United States, CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the Cryoablation System for the treatment of atrial fibrillation and the Cryoablation System has been approved for the treatment of right atrial flutter. For more information please visit the Company's website at http://www.cryocor.com
Forward Looking Statements
The statements in this press release that are not descriptions of historical facts are forward-looking statements that are subject to risks and uncertainties. These include statements related to the safety and effectiveness of CryoCor's cryoablation system, the implications of the study regarding such safety and effectiveness, the benefits of the study being published to CryoCor, and CryoCor's anticipated timing for filing its PMA for AF, all of which are prospective. Such statements are only predictions and reflect CryoCor's expectations and assumptions as of the date of this press release based on currently available operating, financial, and competitive information. The actual events or results may differ materially from those projected in such forward-looking statements due to a number of factors, including risks involved with CryoCor's technology and its effectiveness; risks associated with the Company's dependence on patents and proprietary rights; risks associated with the Company's protection and enforcement of its patents and proprietary rights; risks associated with the development or availability of competitive products or technologies and the other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any intent or obligation to update any of these forward-looking statements.
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