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Natick, Mass.-based Boston Scientific Corporation scored big with the U.S. Food and Drug Administration (FDA) in August, receiving 510(k) clearance of its Zurpaz 8.5 F steerable sheath and pre-market approval of its Intellatip Mifi XP catheter. These products complement Boston Scientific’s portfolio of next-generation electrophysiology (EP) tools. 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 1 million people in the United States. 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 … 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 of the electrophysiology business at 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 8.5 F 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. The sheath has a soft distal tip, updated shaft construction and an ergonomic handle, and is designed to help clinicians deliver catheters consistently and safely during electrophysiology procedures.
“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 1 million people in the United States. 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 … 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 of the electrophysiology business at 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 8.5 F 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. The sheath has a soft distal tip, updated shaft construction and an ergonomic handle, and is designed to help clinicians deliver catheters consistently and safely during electrophysiology procedures.