Cardima Receives CE Mark Approval for its Surgical Ablation Probe with Stabilization Sheath

Surgical Ablation System Capable of Closed-chest and Open-chest Ablation of Left and Right Atria.

Cardima, Inc., a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, today announced that it 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.

“Our discussions with European thought leaders cause us to believe there is a tremendous opportunity in Europe for the Cardima Surgical Ablation System for cardiac ablation procedures,” said Robert Cheney, Chief Executive Officer of Cardima. “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. We plan to market the Cardima Surgical Ablation System in Europe through distribution partners, and will begin treating patients through a network of cardiothoracic surgeon thought-leaders and developing Centers of Excellence at key clinical sites in Europe.”

The Surgical Ablation Probe with Stabilization Sheath is a microcatheter-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 radiofrequency and INTELLITEMP’s “controlled RF” technology. The Probe’s small, flexible design offers sole port-hole access and incorporates irrigation, suction and illumination, which aid in placement and lesion depth.

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.

Source:  Cardima

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