For European release only - Not for use in the US
Estech, a leader in minimally invasive cardiac surgery, announced today that Professor and Doctor of Medicine, Nicolas Doll, Director of the Cardiac Surgery Department of the Sana Klinik for Heart Surgery in Stuttgart, Germany, successfully completed the first Cox-Maze Procedure using the Revolution 2, the latest generation COBRA Revolution Bipolar Clamp. The procedure included a complete bi-atrial lesion set on a 71 year old male patient having persistent atrial fibrillation for 5 years and concomitant arterial bypass grafting using bilateral IMA.
"I am very pleased to be the first surgeon to perform the full Cox-Maze using this novel device," said Dr. Doll. "This bipolar device is very easy to use and enables me to work efficaciously. Importantly, the reversible jaws allow me to access the atrial tissue easily and ergonomically, while the temperature control gives me high confidence in a quality lesion."
The COBRA Revolution Clamp enables deep transmural lesion formation after a single application by utilizing patented temperature control to reach and maintain tissue temperatures at safe, yet highly effective levels. The reversible jaws and softer atraumatic tips, uniquely allow surgeons to follow anatomic contours, for unprecedented ease of use and efficiency.
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. In the U.S., Estech COBRA® products have a cardiac or soft tissue ablation indication, while in Europe, Estech COBRA products are indicated for the surgical treatment of atrial fibrillation using RF surgical ablation. For more information, please visit www.estech.com.
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.
For European release only - Not for use in the US
