FDA Approves AF Ablation Device, But Not Yet For Use As An AF Ablation Device

“The historical problem of attaining atrial wall transmurality reliably in a beating, working heart by applying ablative energy from the epicardium only, appears to have been solved with this new device.”

In short

What’s in a word? In coronary interventions the word ablation usually describes the  act of isolating (by ablation) the pulmonary veins in order to correct atrial fibrillation(AF). Estech, a provider of devices designed to minimally invasively do this “ablation”, has announced the market release of its Cobra Fusion™ system.

In Europe it is indicated for treatment of AF, while in the United States it can be used for “temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device”…. but not yet ablation for AF treatment, which is only allowable under investigational conditions at the present time.

Background

Estech says its technology is the first of its kind to use a unique suction application and innovative electrode configuration to gently pull the tissue targeted for ablation into the device and out of the path of circulating blood. It’s a clever concept, because the so called epicardial ablation of target tissue from outside the heart muscle to inside, is complicated by the cooling effect of circulating blood which tends to stop the internal tissue surfaces gaining the benefit of the ablative energy. The Cobra Fusion™ ablation system overcomes this by effectively sucking the tissue onto a catheter surface, this suction-applied tissue contact acting as a form of tissue clamping to the electrode subsequent to RF energy deliver to create a reproducible, transmural lesions on a beating heart.

Estech reckons its bipolar clamping technology is capable of creating linear lesions anywhere on a beating heart with unprecedented performance and ease of use.

The COBRA Fusion ablation system incorporates proprietary Versapolar™ technology — an exclusive innovation that delivers both bipolar and monopolar radiofrequency (RF) energy to the targeted cardiac tissue, enabling transmural lesion formation in thin and thick cardiac tissue. As with all COBRA® ablation systems, the new device is powered by Estech’s patented temperature controlled radiofrequency (TCRF) energy which continuously monitors and maintains tissue temperature at target levels throughout the procedure. TCRF avoids the need for multiple applications that other technologies often require and ensures that tissue temperatures remain within a safe and effective range.

Clinician comments

James L. Cox, M.D., the pioneer and creator of the Cox‐Maze procedure stated: “I have had the recent opportunity to observe the clinical use of this new device in several patients. The historical problem of attaining atrial wall transmurality reliably in a beating, working heart by applying ablative energy from the epicardium only, appears to have been solved with this new device.” Dr. Cox added: “The ability to involute the atrial wall into the ablation device itself using suction allows for the application of radiofrequency energy to both sides of the involuted tissue, thereby creating reproducible transmural and contiguous linear lesions for the first time off‐pump. Moreover, the device is small enough to fit through a standard port, using an endoscopic port‐access approach. I believe that this device represents a significant addition to the surgeon’s armamentarium in the field of cardiac ablation.” Dr. Cox is the Evarts A. Graham Professor of Surgery Emeritus, Chief, Division of Cardiothoracic Surgery Emeritus, Washington University School of Medicine, Barnes‐Jewish Hospital, St. Louis, Missouri, USA.

Regulatory status

The Estech ablation products are not approved for the treatment of Atrial Fibrillation in the U.S. Estech has received Investigational Device Exemption (IDE) approval from FDA to begin enrollment in a clinical trial to support a PMA submission to obtain a specific atrial fibrillation indication in the U.S. for several products.

In Europe, the Estech COBRA ablation products are CE marked with an indication for the treatment of atrial fibrillation.

Source: Estech