ESTECH Announces COBRA(R) Adhere(TM) Radio Frequency Ablation Device Receives First Ever CE Indication for Surgical Treatment of Atrial Fibrillation (AF)
BARCELONA, Spain--Sept. 28, 2005--ESTECH COBRA(R) Products Receive FDA Marketing Clearance: COBRA(R) Accessory Intended for Use in Atrial Fibrillation Treatment |
At the European Association of Cardiothoracic Surgery (EACTS) Conference ESTECH (Danville, CA) announced that they have received European and US regulatory clearances to market ESTECH COBRA(R) products that are used surgically to treat Atrial Fibrillation (AF). Over five million people in the US and Europe are affected by AF. This heart disease is associated with serious complications and is the leading cause of stroke. ESTECH's COBRA(R) line of products are the first ablation devices available that have received clearance to be marketed specifically for AF.
Ray Bertolero, ESTECH Vice President and co-founder, announced the regulatory clearances today in a large scientific conference of cardiac surgeons saying, "ESTECH's COBRA(R) technology has proven clinical results in treating AF." He went on to say, "The new COBRA devices, which are now available, will offer new treatment options to a significant number of current AF patients."
The ESTECH COBRA(R), COBRA(R) Adhere(TM) XL and the COBRA(R) Bipolar Pacing Probe have recently received US FDA 510K marketing clearance. The COBRA(R) Adhere(TM) Surgical System received the CE mark with an indication for treatment of AF. The COBRA(R) Adhere(TM) is used by surgeons to make lesions on the heart that block the electrical impulses that cause AF. The COBRA(R) Adhere(TM) XL will enable a minimally invasive technique to treat AF. The COBRA(R) Bipolar Pacing Probe is the first RFA accessory in the US and Europe to be intended for the treatment of cardiac arrhythmias. It provides a means for immediately evaluating the effectiveness of AF treatment procedures.
COBRA(R) technology uses a unique intelligent temperature based system that provides both optimal and reproducible results by regulating the RF energy. Other systems offered by AtriCure (ATRC), Medtronic (MDT) and Guidant (GDT) do not have this advanced energy regulation technology.
About ESTECH
ESTECH headquartered in Danville, CA offers tools for least invasive techniques and traditional approaches to the procedures that cardiac surgeons do every day -- coronary artery bypass, valve Surgery, atrial ablation and surgical treatment of congestive heart failure.
Note to Editors: ESTECH, Inc. and "Cobra" are trademarks owned by or licensed to Endoscopic Technologies, Inc.