EP Lab Digest - September 2007 - (Page 24)

24 NEWS SEPTEMBER 2007 CryoCor Receives FDA CardioFocus Approval for Right Atrial Flutter Endoscopic Ablation Continued from page 1 ased on this approval, CryoCor intends to begin selling its cryoablation system in the United States over the next several months.The company will place an initial focus on console placement in high-volume ablation centers in the U.S. and is currently evaluating its sales and marketing requirements for this strategy.The company has targeted an initial installed base of approximately 120 to 160 consoles by December 31, 2008, growing to approximately 300 consoles by 2010. Helen Barold, MD, Chief Medical Officer of CryoCor, said, “I am extremely pleased with the FDA’s decision to approve our Cryoablation System for the treatment of right atrial flutter.There is a large opportunity for treating flutter with cryoablation. Over 200,000 patients per year in the United States are diagnosed with this condition. Many of these patients could benefit from B the unique advantages provided by our system, specifically the fact that cryoablation is a less painful way of ablating right atrial flutter as demonstrated by several published studies.” The FDA’s decision to approve CryoCor’s PMA for right atrial flutter follows an Advisory Panel meeting convened on June 27, 2007. At that panel meeting, the Advisory Panel voted to recommend approval of CryoCor’s PMA, with conditions. To comply with these conditions, CryoCor will implement a formal training program for clinical sites, as well as conduct a two-arm registry study of 650 patients collecting safety and long-term effectiveness data on the use of its cryoablation system as compared to approved radiofrequency catheters in the treatment of right atrial flutter. CryoCor reported that it does not anticipate significant difficulty in complying with the requirements of the registry study. System Earns CE Mark to Treat Atrial Fibrillation; US Clinical Investigation Underway Continued from page 1 eCardio Diagnostics Announces Major Corporate Expansion Cardiac Arrhythmia Monitoring Provider Opening Additional Diagnostic Facility and Increasing Professional Staff Continued from page 1 arry Lawson, President and CEO of eCardio Diagnostics commented, “We are extremely proud of what this milestone represents. Since our inception, our mission has been to differentiate ourselves with superior focus and responsiveness to our Client’s needs, providing them with the best overall services possible.We feel that delivering on this objective has contributed significantly to the rapid and sustained growth we are experiencing.” Frost & Sullivan’s Patient Monitoring Research Analyst, Mr. Zachary Bujnoch, added, “eCardio has achieved a level of customer attentiveness and T L service that clearly sets them apart. Consequently, they have earned our Customer Service Leadership Award both of the last two years this award was conferred within their industry segment.” He concluded,“It is gratifying to see this translate into their continued growth and expansion.” The additional facility is conveniently located, features leading-edge equipment, technologies and connectivity throughout and will serve as the workplace for eCardio’s diagnostic laboratory technologists, reimbursement specialists and several of their information technology staff members. he Endoscopic Ablation System has been designed to treat atrial fibrillation, a disease that affects more than 5 million people in Europe and the United States, in addition to millions more worldwide. “We’re very gratified to have achieved this level of confirmation for the work we have accomplished and the potential for aiding patients afflicted with atrial fibrillation worldwide,” said Stephen Sagon, the company’s President and CEO. “The CE Mark confirms our satisfaction of the EU medical device directives and assures patients and clinicians that our European clinical results and our manufacturing quality systems are of high caliber.” The CardioFocus Endoscopic Ablation System has also received US IDE approval for clinical investigation in a randomized, multi-center study, currently underway and enrolling patients at over a dozen leading medical centers across the country. Patients with symptomatic paroxysmal atrial fibrillation may learn about inclusion and exclusion criteria for the ENABLE trial, including information about participating centers at “http://www.clinicaltrials.gov/ct/show/NCT0047723 0?order=1”. Study co-principal investigator Andrea Natale, MD of the Cleveland Clinic Foundation commented, “I am very satisfied with our ability to access anatomical targets and to achieve electrical isolation.The realtime view using the Endoscopic Ablation System provides a truly unique opportunity to tailor ablation therapy in a highly variable clinical setting.” His colleague and study co-principal investigator Vivek Reddy of the Massachusetts General Hospital said, “Today, there are no devices specifically approved in the U.S. to treat this challenging arrhythmia. Multiple products are being used to pursue a variety of different strategies, but these are limited by the inability to directly visualize the tissue being ablated. The CardioFocus technique provides a new capability to directly address the difficult navigational challenges clinicians face in treating patients with symptomatic paroxysmal atrial fibrillation”. http://www.clinicaltrials.gov/ct/show/NCT00477230?order=1 http://www.clinicaltrials.gov/ct/show/NCT00477230?order=1

Table of Contents Feed for the Digital Edition of EP Lab Digest - September 2007

The ICD Shock and Stress Management Program: Interview with Samuel F. Sears Jr., PhD Universal ECG Screening: The Advocate’s Perspective Contents Letter from the Editor Spotlight Interview: Morristown Memorial Hospital 10-Minute Interview: About the Mended Hearts and Mended Little Hearts Organizations ICD Patient Support Groups Email Discussion Group: September 2007 Technology: Only As Good As the Attitude Behind It! Electrophysiologic Management and Treatment of Chronic and Acute Cardiac Device Infection First Annual EP Lab Digest Salary Survey Events Calendar Industry News and Products

EP Lab Digest - September 2007

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