FREMONT, Calif.--(BUSINESS WIRE)--Cardima, Inc. (OTCBB:CADM - News), 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.
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.”
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.
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®, REVELATION®, INTELLITEMP®, VUEPORT® and NAVIPORT® are registered trademarks of Cardima, Inc.
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.
Richard Gaston, M.D., 510-354-0300
Lippert/Heilshorn & Associates
Jody Cain, 310-691-7100