Cardima announces CE Mark approval for Surgical Ablation Probe in Surgical Treatment of Atrial Fibrillation

Mar 29 2010

Cardima, Inc. (OTCBB:CADM), 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 with an Indication for the Surgical Treatment of Atrial Fibrillation for its Surgical Ablation Probe. All components of the Cardima Surgical Ablation System are now approved for marketing for the treatment of AF in European countries recognizing CE Mark approval.

“Following the procedure, we anticipate that patients typically will stay in the hospital overnight and be discharged the next day. We believe that the cost savings and advantages to patients, hospitals and physicians will assist in the acceptance and distribution throughout Europe.”

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 significantly less invasive than current prevailing surgical treatments for AF. The Cardima Surgical Ablation 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.

"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," said Robert Cheney, Chief Executive Officer of Cardima. "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."

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 unique and 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.

"The Cardima Surgical Ablation System used in a stand-alone procedure can reduce risk, as well as patient discomfort and recovery time," added Mr. Cheney. "Following the procedure, we anticipate that patients typically will stay in the hospital overnight and be discharged the next day. We believe that the cost savings and advantages to patients, hospitals and physicians will assist in the acceptance and distribution throughout Europe."