FDA Clears Boston Scientific IntellaTip MiFi XP Ablation Catheter and Steerable Sheath
August 21, 2013 — The U.S. Food and Drug Administration (FDA) approved Boston Scientific’s IntellaTip MiFi XP catheter and granted 510(k) clearance for the Zurpaz 8.5 French steerable sheath for electrophysiology (EP) ablation procedures.
"The IntellaTip MiFi XP is a unique high resolution catheter which provides information that allows electrophysiologists to pinpoint locations for ablation, a key element needed for success," said Tom McElderry, M.D., director of electrophysiology, University of Alabama Hospital. "In my experience with this technology, it proved especially useful in identifying areas of interest for diagnosis and ablation. This level of high resolution electrogram is something we have never seen before and I believe it will open a whole new array of possibilities in EP."
IntellaTip MiFi XP is indicated for ablation of atrial flutter, an arrhythmia that affects nearly 1 million people in the United States. The catheter features sophisticated mini electrodes on the tip designed to provide information about tip location and help clinicians assess lesion maturation and differentiate viable from non-viable tissue.
For more information: www.bostonscientific.com