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Boston Scientific Wins FDA Approval for IntellaTip MiFi XP Ablation Catheter, 510(k) Clearance of Zurpaz 8.5F Sheath

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Boston Scientific Corporation (NYSE: BSX) continues to expand its electrophysiology (EP) offerings with U.S. Food and Drug Administration (FDA) approval of its IntellaTip MiFi™ XP catheter and 510(k) clearance of its Zurpaz™ 8.5F steerable sheath.  These products join the company's growing portfolio of next generation EP tools designed to redefine ablation technology.  Catheter ablation, a procedure in which localized electrical energy is delivered into the heart tissue and is aimed at restoring the continuous normal rhythm, has become a first-line treatment approach for patients with certain kinds of irregular heartbeats.

"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 one 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. 

"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.  

Posted-In: News FDA


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