Boston Scientific‘s IntellaTip MiFi XP ablation catheter has successfully cleared its clinical trials and the company was given FDA approval to introduce the device in the U.S. for treatment of atrial flutter.
The device provides higher resolution electrograms of the heart (Instagrams of the heart’s electric anatomy) than any other ablation catheter thanks to a novel set of electrodes around the device tip.
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“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.