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Cardima Receives CE Mark For Surgical Ablation System

Cardima, a manufacturer of surgical ablation system, has received CE mark approval with an indication for the surgical treatment of atrial fibrillation for its surgical ablation probe.

The Cardima Surgical Ablation System can be used in open-chest surgery in conjunction with other procedures, or as a thoracoscopic stand-alone, closed-chest procedure. The closed-chest procedure is less invasive than current prevailing surgical treatments for AF. The system allows a trained cardiac surgeon to gain access to the heart through two or three small ports in the chest, making a large incision or sternotomy unnecessary.

The Surgical Ablation Probe with Stabilization Sheath is a catheter-based surgical probe powered by the company’s IntelliteMP radiofrequency (RF) energy management device. Together these components comprise the Cardima Surgical Ablation System.

The Surgical Ablation Probe allows for creation of cardiac lesions without gaps through the use of temperature-regulated RF energy and the IntelliteMP’s patented technology that controls each high efficiency electrode individually.

The Probe’s flexible design offers total ‘port hole’ access and incorporates irrigation and suction to increase lesion depth and illumination to aid in probe placement. The IntelliteMP affords individual electrode monitoring in real time as well as temperature control and feedback to the surgeon, a feature unique to Cardima’s system.

Robert Cheney, chief executive officer of Cardima, said: “We are currently establishing surgical ablation programs for AF in Ireland and the Netherlands and will expand over time into other European countries. Obtaining a CE Mark indication for the treatment of AF is a significant regulatory step forward and will assist us in developing relationships with surgeons and surgical centers across Europe.

“Our Cardima Surgical Ablation System has patented technology that allows for creating deep, long, linear and transmural cardiac lesions that mimic the current gold standard, the Cox Surgical Maze, in the treatment of AF. Unlike the highly invasive Cox Maze or similar open chest procedures, the Cardima Surgical Ablation System can be used in either closed- or open-chest procedures. Additionally, our system treats both the left and right atria, which we believe is necessary for the successful treatment of arrhythmia.”