Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath.
The IntellaTip MiFi XP is a high resolution catheter that provides information about tip location and helps electrophysiologists to assess lesion maturation and differentiate viable from non-viable tissue.
The IntellaTip MiFi XP is indicated for ablation of atrial flutter, a cardiac abnormality that affects nearly one million people in the US.
It is the only available catheter in the market to provide high resolution electrograms of the heart.
Boston Scientific electrophysiology general manager Pete Sommerness noted that following the recent FDA 510(k) clearance of the company’s novel Rhythmia Mapping System, adding the IntellaTip MiFi XP to its portfolio further reinforces its commitment to redefining ablation and diagnostic tools for the EP physician, especially since the catheter is compatible with the Rhythmia system.
"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," Sommerness added.
The FDA also cleared Zurpaz 8.5F steerable sheath, used to access the heart during catheter placement in a variety of procedures including treatment of atrial flutter, atrial fibrillation and ventricular tachycardia.
The soft distal tip, advanced shaft and an intuitive ergonomic handle help clinicians to deliver catheters consistently and safely during electrophysiology procedures.