News | May 16, 2013

First-In-Human Trial Completed for Type 1 Atrial Flutter Ablation Catheter

May 16, 2013 — Boston Scientific Corporation completed a first-in-human clinical trial utilizing the IntellaTip MiFi XP Ablation Catheter for the treatment of type 1 atrial flutter, an arrhythmia originating in the right atrium of the heart that affects nearly 1 million people in the United States. This single center feasibility trial enrolled 10 patients and was led by Prash Sanders, MBBS, Ph.D., FHRS, director of the Centre for Heart Rhythm Disorders at the University of Adelaide and the Royal Adelaide Hospital in Australia.

Patients with type 1 atrial flutter may exhibit symptoms that include palpitations, shortness of breath, fatigue, lightheadedness and fainting. Catheter ablation, a procedure in which localized electrical energy is delivered into the heart tissue aimed at restoring the continuous normal rhythm, has become a first-line treatment approach for patients with recurrent type 1 atrial flutter and demonstrates more successful short- and long-term outcomes compared to anti-arrhythmic drug therapy.

The IntellaTip MiFi XP Catheter is the first addition to the IntellaTip family of ablation catheters Boston Scientific expects to unveil over the coming years. This new line of ablation catheters is designed to provide physicians with high resolution, precise, multidimensional information through sophisticated micro-sensors at the tip of the catheter.

"The IntellaTip MiFi XP Catheter provided all of the benefits of a large tip catheter while allowing significantly more detailed mapping," said Sanders. "The catheter handling was intuitive and I found that the mapping capabilities gave me greater ability to identify gaps and know where to ablate. Potentially reflecting this, we had several procedures where the ablation time was quite short compared to conventional ablation technology."

"We believe the design of the IntellaTip MiFi technology will redefine the quality of critical electrical information that electrophysiologists depend on during ablation procedures," said Pete Sommerness, general manager, electrophysiology, Boston Scientific. "This technology demonstrates our commitment to providing electrophysiologists with innovative solutions to help improve the health of patients around the world."

Electrophysiology is a $2.5 billion market growing at a double-digit pace and represents a key growth area for Boston Scientific. The IntellaTip MiFi XP is an investigational device and is not available for sale.

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