CardioFocus (Marlboro, MA) recently conducted two “live cases” using its Endoscopic Ablation System—the first of which was a satellite transmission performed at Centro Cardiologico Monzino (Milan, Italy) and broadcast to the 16th Annual Boston Symposium on Atrial Fibrillation (Boston, MA). Several pioneers in the treatment of atrial fibrillation served as moderators for this educational presentation, providing perspective on ablation procedures designed to isolate pulmonary veins (PVs). The second live case was performed at St. Georg Hospital (Hamburg, Germany) by Prof. Karl-Heinz Kuck. Both cases demonstrate the continued interest of catheter ablation experts to gain a real-time view of the anatomy they are treating to enable durable PV isolation.
“These back-to-back live cases provide CardioFocus with a unique opportunity to be seen by clinicians from around the world,” said Stephen Sagon, CEO of CardioFocus. “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 PVs has been reported by CardioFocus clinical investigators at over 99% in peer-reviewed articles. While nearly all of the PVs 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 three months.
“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,” according to Burke Barrett, CardioFocus Vice President of Clinical and Regulatory Affairs.
Two years after the initiation of clinical research, approximately 250 patients have been treated under multiple research protocols at 16 different medical centers worldwide. More than 150 patients were treated in the EU and almost 100 patients were enrolled in a U.S. feasibility clinical trial.
The CardioFocus system is not approved by the FDA, and no conclusions can or should be drawn regarding its safety or effectiveness.