Boston Scientific Corporation
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.
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