Two Laser Balloon 'Live Cases' Shed New Light on Direct Visualization and PV Ablation

By Cardiofocus, PRNE
Sunday, January 23, 2011

A Tipping Point for CardioFocus

MARLBOROUGH, Massachusetts, January 25, 2011 - CardioFocus announced that two "live cases" using its Endoscopic Ablation
System were recently conducted. The first live case was a satellite
transmission performed at Centro Cardiologico Monzino in Milan, Italy;
broadcast to the 16th Annual Boston Symposium on Atrial Fibrillation in
Boston, MA. Several pioneers in the treatment of atrial fibrillation served
as moderators for this exciting educational presentation, providing
perspective on ablation procedures designed to isolate pulmonary veins.

The second live case was performed at St. Georg Hospital, in Hamburg,
Germany
, by Prof. Karl-Heinz Kuck. Both cases demonstrate the continued
interest of leading catheter ablation experts to gain a real time view of the
anatomy they are treating to enable durable PV isolation.

Stephen Sagon, CEO of CardioFocus said, "These back-to-back live cases
provide CardioFocus with a unique opportunity to be seen by clinicians from
around the world. Now that we have CE Mark approval for the latest version of
our equipment, we have received requests from multiple, well-respected
international arrhythmia centers. We plan to continue our highly disciplined
launch of the Endoscopic Ablation System at key European sites in 2011."

The acute isolation rate of pulmonary veins has been reported by
CardioFocus clinical investigators at over 99% in peer reviewed articles.
While nearly all of the pulmonary veins were isolated during the procedure,
78% of veins were isolated on the very first attempt. Chronic PV isolation
was reported to approach 90% when assessed at 3 months. According to Burke
Barrett, CardioFocus Vice President of Clinical and Regulatory Affairs, "We
expect more scientific studies and further presentations on our Endoscopic
Ablation System technology throughout the year, including the company's US
IDE pivotal study in the first half of 2011."

Two years after the initiation of clinical research, approximately 250
patients have been treated under multiple research protocols at 16 different
medical centers world-wide. More than 150 patients were treated in the EU and
almost 100 patients were enrolled in a US feasibility clinical trial.

The information in this news release related to our product is
preliminary and investigative. The CardioFocus System is not approved by the
FDA, and no conclusions can or should be drawn regarding its safety or
effectiveness.

    CONTACT: CardioFocus, Marlborough MA, USA
             Maria Shepherd +1-617-548-9892 (media)

Maria Shepherd, CardioFocus, +1-617-548-9892

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