SAN RAMON, Calif.--(BUSINESS WIRE)--Apr 3, 2012-- Estech, a leader in minimally invasive and endoscopic cardiac ablation, announced today that the Food and Drug Administration (FDA) has given conditional Investigational Device Exemption (IDE) approval to initiate patient enrollment in the Estech-sponsored ATTAC-AF trial. The IDE trial has been designed to evaluate the treatment of atrial fibrillation (AF) utilizing temperature-controlled radiofrequency (TCRF) ablation in patients undergoing cardiac surgery. Up to 15 centers in the United States and Europe will participate in the trial, which is intended to enroll over 100 cardiac surgery patients.
The ATTAC-AF trial will enroll cardiac surgery patients who have a history of non-paroxysmal AF. During the cardiac surgical procedure for treatment of coronary or valve disease, patients will also be treated for their atrial fibrillation disease with Estech's COBRA(R) Ablation probes utilizing patented TCRF technology. Patients enrolled in the ATTAC-AF trial will be followed for a minimum of one year to determine the success rate for preventing recurrence of AF and to assess the patient's quality of life following the ablation procedure.
For patients referred for cardiac surgery, non-paroxysmal atrial fibrillation is exceptionally important because its associated morbidity causes significantly poorer survival rates compared to patients with normal sinus rhythm (NSR). Approximately, 30 to 40% of patients undergoing mitral valve repair have pre-existing non-paroxysmal AF. Patients in NSR following mitral valve operation have increased one and four year survival rates compared with those in AF. The increased rates of morbidity and mortality associated with patients who remain in AF after surgery demonstrate the need for an effective and reliable treatment for AF.
"This is a very important study to get the indication to treat atrial fibrillation surgically," said the principal investigator Niv Ad, MD, Chief of Cardiac Surgery and Director of Cardiac Surgery Research at Inova Heart & Vascular Institute, Virginia, USA. "I have found Estech's temperature-controlled RF technology to be of very high quality and Estech employees to be dedicated and committed to excellence in cardiac ablation," Dr. Ad continued. "With the anticipated participation of some of the best cardiac surgery centers in the U.S. and Europe, this promises to be an excellent study." About Estech Estech develops and markets a broad portfolio of innovative medical devices that enable cardiac surgeons to perform a variety of surgical procedures, while specializing in minimally invasive and hybrid ablation. The COBRA line comprises the first technology invented, developed and brought exclusively to the surgical ablation market.
Temperature-controlled RF energy delivery, suction-assisted tissue contact and internally-cooled devices provide superior ablation performance compared to other ablation systems. For more information, please visit www.estech.com.
COBRA(R) Surgical System: Disclaimer In the U.S., the COBRA Adhere XL, COBRA Cooled and COBRA Surgical probes have been cleared for cardiac ablation. The Estech COBRA Revolution has been cleared for ablation of soft tissues. The AFfirm Pacing Probe has been cleared to be used upon completion of the cardiac ablation procedure to assess the adequacy of cardiac lesions created in surgically treating the patient's arrhythmia. Estech does not promote off-label use of its products and their use is at the discretion of the cardiac surgeon. Estech has received conditional Investigational Device Exemption (IDE) approval from FDA to begin enrollment in a clinical trial to support a Premarket Approval (PMA) submission in the U.S. to obtain a specific atrial fibrillation indication for several products. In Europe, the Estech COBRA RF ablation products are CE marked with an indication for the treatment of atrial fibrillation by ablating cardiac tissue during surgery.
CONTACT: Estech Jean Zartler, +1-925-543-2194 Director of Marketing firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: HEALTH CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES FDA GENERAL HEALTH SOURCE: Estech Copyright Business Wire 2012 PUB: 04/03/2012 06:00 AM/DISC: 04/03/2012 06:00 AM http://www.businesswire.com/news/home/20120403005615/