Biosense Webster, a Johnson & Johnson company, announced U.S. release of the first Dual Sensor 8 mm tip ablation catheters specifically designed for the treatment of atrial flutter. The NAVISTAR™ DS and CELSIUS™ DS catheters received marketing clearance by the U.S. Food and Drug Administration on September 30, 2002.

Roy Tanaka, U.S. President of Biosense Webster, said "U.S. introduction of the first Dual Sensor 8 mm Tip Catheters reinforce our commitment to remain at the forefront of advanced catheter technology. Our company had achieved an industry milestone by providing clinicians with the first approved product for atrial flutter ablation/"

Industry sources estimate that less than 20% of patients with atrial flutter are referred for ablation therapy. Yet, while available pharmaceutical treatments are only palliative, a successful ablation can be curative and eliminate the arrhythmia. Although atrial flutter ablations are challenging with standard catheters, the new Dual Sensor 8 mm tip catheters are designed to simplify the ablation procedure for all electrophysiologists.

NAVISTAR™ DS and CELSIUS™ DS Catheters are designed to benefit electrophysiologists by providing greater temperature control while delivering a long, deep lesion across the isthmus to achieve anatomical blocks with fewer ablations.

Compared to standard 4 mm tip catheters, the larger 8 mm tip on both dual sensor catheters has a much larger surface area exposed to local blood flow during a procedure. This blood flow serves to cool the tip, enabling the delivery of higher energy levels — up to 70 watts with the Stockert 70 RF Generator. The presence of two temperature sensors in the 8 mm tip facilitates precise temperature control that can help to reduce the risks of incomplete, low temperature ablations or excessively high temperatures at the tip that can cause char and coagulum formation.

Dr. David Wilbur of Loyola University Medical Center, lead investigator for the NAVISTAR™ DS Clinical Trial, said "The 8 mm NAVISTAR™ Catheter provides effective cooling, confirmed both by clinical and experimental data. The dual sensor technology is an important safety feature, allowing the physician to optimize energy delivery and lesion size, while avoiding charring, coagulum and steam pops," he said. "These characteristics facilitate the production of permanenet, bidirectional isthmus conduction block, making atrial flutter ablations easier than in the past with the 4 mm tip. Clinical efficacy for patients ablated with the NAVISTAR™ DS catheter was high in both acute success and 6-month freedom from recurrence at 98.8% and 96.7%, respectively."

Both the NAVISTAR™ DS and the CELSIUS™ DS Catheters are designed to increase the confidence of electrophysiologists as they tackle the challenges of creating successful atrial flutter ablations. Mr. Tanaka noted "We continue to explore and develop catheter technologies that will broaden the electrophysiologist's ability to treat more complex arrhythmias with increased confidence and effectiveness."