Cardima wins CE Mark for new surgical ablation system

Cardima, a medical device company, has received CE Mark approval for its Surgical Ablation Probe with stabilization sheath.

All components of the Cardima Surgical Ablation system are now approved for marketing in European countries recognizing CE Mark approval. The Cardima Surgical Ablation system can be used in open-chest surgery in conjunction with other procedures, or as a thoroscopic stand-alone, closed-chest procedure.

According to Cardima, the Surgical Ablation Probe with stabilization sheath is a microcatheter-based surgical probe powered by the company’s Intellitemp radiofrequency 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 radiofrequency and Intellitemp’s controlled radiofrequency technology.

The Cardima Surgical Ablation system used in a stand-alone procedure can reduce risk, as well as patient discomfort and recovery time, typically requiring only a single night hospital stay, which compares favorably to other ablation procedures, the company said.

Robert Cheney, CEO of Cardima, said: Our system has patented technology that allows for creating deep, long, linear and transmural cardiac lesions. 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 arrhythmias.