Cardima's Surgical Ablation System breakthrough for patients with heart disease

Fremont 16 September 2003In February 2003, Cardima Inc. received approval from the Food and Drug Adminitration for their Surgical Ablation System in the United States. The Cardima Ablation System was first utilized by cardiac surgeons at New York City's Lenox Hill Hospital to repair damaged heart tissue in patients with a long history of chronic Atrial Fibrillation (AF) in conjunction with valve disease.


According to the American Heart Association, about five million Americans are diagnosed with valve disease each year, a condition that occurs when the heart's valves fail to pump blood into and out of the heart properly. Patients with valve disease also have a 50 percent incidence of AF, a disturbance in the heartbeat in the top two chambers of the heart.

Valve disease can be treated with medications, but in cases where much damage has occurred, surgery is required. However, both conditions can now be simultaneously treated using the FDA-approved Cardima Surgical Ablation System. Approximately 225.000 heart valve procedures are performed worldwide each year. Untreated, valve disease can cause shortness of breath and/or difficulty catching your breath, dizziness, weakness, chest pain, edema or body swelling, and palpitations.

The system is composed of a surgical ablation probe, an energy management device, and a unique delivery system. These collectively enable the surgeon to create curvilinear scars in the heart muscle or walls. This scar tissue blocks the signals which cause the heart to go into atrial fibrillation. This represents a significant possibility for surgeons to effectively treat atrial fibrillation.

Dr. Didier F. Loulmet, M.D., Chief of the Minimally Invasive Robotic Cardiac Surgery Programme at Lenox Hill Hospital, who also heads the hospital's Atrial Fibrillation Programme, reported: "The unique technology behind the Cardima Ablation System proved to be a critical and powerful tool in these especially difficult cases."

"Now, in one operation, patients can have two procedures to treat both their valve conditions and their chronic AF episodes. This offers the advantage of reducing the time needed for the treatment of two separate heart conditions and thereby significantly reducing the patient's overall recovery time", stated Dr. Loulmet.

More information on the Cardima Surgical Ablation System can be found in the VMW Septebmer 2003 article Cardima to launch Surgical Ablation System with radio frequency in the United States market.

Leslie Versweyveld

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