Cardima Receives CE Mark Approval For Its Surgical Ablation Probe With Stabilization Sheath

Main Category: Medical Devices / Diagnostics
Also Included In: Heart Disease;  Regulatory Affairs / Drug Approvals;  Cardiovascular / Cardiology
Article Date: 02 Apr 2009 - 2:00 PDT

email to a friend   printer friendly   view / write opinions

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 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.

About Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major concern for healthcare providers worldwide. An estimated 25 million people worldwide suffer from AF, which is increasing at a compound annual growth rate of approximately 20%. Considered the largest unmet need in cardiology today, the market represents an estimated $17 billion in annual revenues. AF symptoms typically include a rapid and irregular heartbeat, palpitations, discomfort and dizziness. During AF episodes, irregular, disorganized and quivering spasms of atrial tissue result in the heart's failure to pump adequate amounts of blood throughout the body. AF is a leading cause of stroke, can cause congestive heart failure and adds to the morbidity of any underlying heart disease. Recent estimates are that more than 2.5 million people in the U.S. have AF, of which 1 million are symptomatic, yet do not respond well to drug therapy. The cause of AF is unknown and there is no variation by geography or ethnicity. The incidence of AF increases with age. Furthermore, about 200,000 new cases are diagnosed each year in the U.S.

About Cardima

Cardima, Inc. has developed the PATHFINDER ® Series of diagnostic catheters, and the NAVIPORT® deflectable guiding catheter, the INTELLITEMP® Energy Management Device and the Surgical Ablation System. All of these Cardima devices have received CE mark approval and U.S. Food and Drug Administration (FDA) 510(k) clearance. The REVELATION® Series of ablation catheters with the INTELLITEMP® EP Energy Management Device, developed for the treatment of atrial fibrillation (AF), has received CE mark approval and is marketed in Europe. PATHFINDER®, NAVIPORT®, VENAPORT®, VUEPORT®, TRACER™, REVELATION® and INTELLITEMP® are registered trademarks of Cardima, Inc.

Forward-Looking Statements

This press release may contain forward-looking statements, including but not limited to the use of the Cardima Surgical Ablation System in a stand-alone procedure can reduce risk, as well as patient discomfort and recovery time requiring only a single night hospital stay, the system treats both the left and right atria which is necessary for the successful treatment of arrhythmia, and the cost savings to patients, hospitals and physicians providing tremendous sales opportunities in Europe. These statements are subject to risks and uncertainties. Investors are referred to the full discussion of risks and uncertainties associated with forward-looking statements as contained in our reports to the Securities and Exchange Commission, including our Forms 10-K and 10-Q. The Company assumes no obligation to update the forward-looking information.

Source
Cardima, Inc.