FDA Clears Boston Scientific IntellaTip MiFi XP Ablation Catheter and Steerable Sheath
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 provides information that allows electrophysiologists to pinpoint locations for ablation. Users say it is especially useful in identifying areas of interest for diagnosis and ablation with its high resolution electrogram.
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.
The products were approved by the FDA in August 2013.
For more information: www.bostonscientific.com