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