New Technology Combines Unprecedented Lesion Effectiveness with Ergonomic Ease of Use
San Ramon, Calif. --- October 4, 2010 --- Estech, a leading provider of minimally invasive cardiac surgery devices, today announced the launch of its COBRA Revolution™ Bipolar Clamp for use in surgical ablation procedures. The new instrument enables deep transmural lesion formation after a single application and is the only clamp to feature reversible jaws, which uniquely allows surgeons to follow anatomic contours, for unprecedented ease of use and efficiency. The COBRA Revolution Bipolar Clamp is the latest addition to Estech’s COBRA ablation product line, which features the company’s patented temperature-controlled radio frequency (TCRF) technology for superior patient safety and clinical effectiveness.
“The COBRA Revolution bipolar clamp offers ‘leapfrog’ technology in bipolar surgical ablation,” said John Pavlidis, Estech’s president and chief executive officer. “It enables the creation of deep lesions after a single application, which can save valuable time. Furthermore, it functions as two clamps in one, rotating fluidly between left and right curvatures. This gives the surgeon the convenience and safety of following the proper anatomic orientation, without the extra cost of a second device.”
Estech’s COBRA technology uniquely maintains preset tissue temperatures at safe, effective levels. This enables the new device to produce reliable lesions while avoiding patient morbidities or the application of numerous lesions in order to be effective.
Brian W. Hummel, M.D., F. A. C. S., Managing Partner GulfCoast Cardiothoracic and Vascular Surgeons has been using the new Estech bipolar clamp and said, “This new clamp represents Estech’s commitment to supplying the cardiothoracic surgeon with high quality, cost-effective ablation technology.”
The COBRA Revolution Bipolar Clamp has been cleared by the U.S. Food and Drug Administration for soft tissue ablation, and recently received CE mark approval, allowing the company to market the product to European Union countries. Estech’s COBRA ablation products, which include the COBRA Adhere XL surgical catheter, the COBRA Cooled linear epicardial surgical catheter, the COBRA standard linear catheter and the COBRA AFfirm Pacing Probe, are backed by nearly 100 patents and have been used in more than 15,000 procedures worldwide.
Estech develops and markets a broad portfolio of innovative medical devices and disposables that enable cardiac surgeons worldwide to perform a variety of traditional surgical or minimally invasive procedures, including the growing trend in hybrid ablation procedures, with superior ease of use, patient safety and clinical effectiveness. Estech uniquely focuses solely on the cardiac surgeon. The company’s product lines span three cardiac surgery disciplines, including temperature-controlled RF ablation, valve replacement and repair, and coronary artery bypass grafting. Estech markets its products in the U.S. and in more than 40 countries internationally through a direct sales force and a select network of distributors. Estech is privately held and backed by a number of leading life sciences venture capital firms in Silicon Valley and Europe. The company is headquartered in San Ramon, Calif., with a facility in the Netherlands. For more information, please visit http://www.estech.com.
Mark A. Koeniguer, Vice President of Marketing
COBRA® Surgical System: Disclaimer
In the U.S., the Estech COBRA Revolution and COBRA Bipolar Inserts have been cleared for ablation of soft tissues. The COBRA Adhere XL, COBRA Cooled and COBRA Surgical probes have been cleared for cardiac ablation. 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 is undertaking an Investigational Device Exemption (IDE) clinical trial and subsequent Premarket Approval Application (PMA) submission in the US to obtain a specific atrial fibrillation indication. 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.