FDA approval for IntellaTip MiFi XP ablation catheter and 510(k) clearance of Zurpaz 8.5F steerable sheath


Boston Scientific Corporation has announced it has received US Food and Drug Administration (FDA) approval of its IntellaTip MiFi XP catheter and 510(k) clearance of its Zurpaz 8.5F steerable sheath.

“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, director of Electrophysiology, University of Alabama Hospital, USA. “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. The catheter features 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.

“Following the recent FDA 510(k) clearance of our novel Rhythmia Mapping System, adding the IntellaTip MiFi XP to our portfolio further reinforces our commitment to redefining ablation and diagnostic tools for the EP physician-especially since the catheter is compatible with the Rhythmia system,” said Pete Sommerness, general manager, Electrophysiology, Boston Scientific. “We believe that the IntellaTip MiFi XP approval, combined with the introduction of our Zurpaz steerable sheath, demonstrates how we are delivering on our promise to provide electrophysiologists with meaningful innovation and complete solutions.”

The Zurpaz 8.5F steerable sheath is cleared to gain access to the heart, facilitating placement of catheters for use in a variety of procedures including treatment of atrial flutter, atrial fibrillation and ventricular tachycardia. With enhanced features, including a soft distal tip, advanced shaft construction and an intuitive ergonomic handle, Zurpaz is designed to help clinicians deliver catheters consistently and safely during electrophysiology procedures.