EP Lab Digest - April 2008 - (Page 58)

58 NEWS APRIL 2008 CryoCor Atrial Fibrillation Study Published in the Journal of the American College of Cardiology ryoCor, Inc., a medical device company focused on the treatment of cardiac arrhythmias, announced the publication of a study on the treatment of atrial fibrillation (AF) 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 during a mean follow-up averaging 33 months. This study reviewed safety and long-term efficacy of AF ablation utilizing cryotherapy. 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 radiofrequency, 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 C 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, ten 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, PhD, 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. Clinical Data, Inc. Announces Expanded ® Reimbursement for the FAMILION Long QT Syndrome Genetic Test linical Data, Inc., a leader in the development of targeted therapeutics and predictive tests from its growing portfolio of proprietary genetic biomarkers, announced that its PGxHealth™ division has achieved significant growth in positive reimbursement policies for its FAMILION® genetic test for Long QT Syndrome (LQTS). Since January 1, 2008, additional private health insurers have adopted positive reimbursement policies related to genetic testing for LQTS, resulting in a total of 65 million lives now covered by these policies, up from 49 million lives at the end of 2007. PGxHealth is now also an approved laboratory provider for Medicaid in 13 states, covering an additional 9 million lives. An additional 24 state Medicaid agencies have indicated that coverage is pending, and applications have been submitted to the remaining 13 states. PGxHealth is also an approved Medicare provider and the FAMILION LQTS test is reimbursed by Medicare. Plans that have adopted positive coverage policies have determined that the FAMILION LQTS test is medically necessary for certain patients. “PGxHealth is committed to providing this important genetic test to patients and physicians, and we are investing significant resources to obtain insurance coverage for patients who need our LQTS test,” said Carol Reed, MD, Executive Vice President and Chief Medical Officer of Clinical Data, Inc.“This growth in private insurance and Medicaid coverage reflects increasing payer acknowledgement of the test's benefits and greater adoption among healthcare providers.” In a recent related development, Clinical Data announced on February 5, 2008 that C its FAMILION LQTS test met the Blue Cross and Blue Shield Association Technology Evaluation Center's (TEC) criteria for establishing the diagnosis of LQTS in certain individuals. In addition, a guideline issued in 2006 by the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee stated, “Genetic analysis is very important for identifying all mutation carriers within an LQTS family. Once identified, silent carriers of LQTS genetic defects may be treated with beta blockers for prophylaxis of life-threatening arrhythmias. Furthermore, silent mutation carriers should receive genetic counseling to learn about the risk of transmitting LQTS to offspring.” The guideline also stated, “In patients affected by LQTS, genetic analysis is useful for risk stratification and for making therapeutic decisions.” The FAMILION family of tests detect genetic mutations that can cause cardiac channelopathies. These are rare, potentially lethal heart conditions, including LQTS, Brugada Syndrome (BrS) and Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). By detecting genetic mutations, the FAMILION tests can be used to recognize inherited forms of cardiac channelopathies in individuals and their families, helping to guide treatment and reduce the deadly cardiac events they can cause. For cardiac channelopathies that have already been diagnosed, the test can help doctors and patients make more informed treatment decisions and aid in uncovering other possibly asymptomatic family members that may be at risk.

Table of Contents Feed for the Digital Edition of EP Lab Digest - April 2008

EP Lab Digest - April 2008 Pediatric Electrophysiology Medical Relief Work on the Yucatan Peninsula: A Labor of Love EP 101: Considerations for the Elderly EP Patient Contents Letter from the Editor Spotlight Interview: University of Maryland A Summary of the ACC/AHA/Physician Consortium 2008 Clinical Performance Measures for Adults with Nonvalvular Atrial Fibrillation or Flutter Can Psychosocial Characteristics Predict Fatal Outcomes in Patients? Interview with Jonathan S. Steinberg, MD, FACC 10-Minute Interview: Diane D. Sheffield, RN, BSN AED Access for All: An Organization for SCA Survivors New Column: 5 Quick Clues to AV Nodal Reentry Tachycardia CMS 2008 OPPS Final Rule Review New Online AED and CPR Training Opportunities: Q & A with Keith Weaver Highlights from the 5th Annual International Arrhythmia Winter School Email Discussion Group Events Calendar Second Annual Salary Survey Industry News and Products Classifieds Advertisers Index

EP Lab Digest - April 2008

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