Boston Scientific Wins CE Mark Approval for Rhythmia Mapping System
Boston Scientific Corporation
(NYSE: BSX) has received CE Mark approval for the Rhythmia Mapping System, a
next-generation 3D mapping and navigation solution for use in cardiac catheter
ablations and other electrophysiology (EP) procedures to treat a variety of
conditions in which the heart beats abnormally. Some of those conditions
include atrial flutter, atrial fibrillation and ventricular tachycardia.
Boston Scientific is offering the Rhythmia Mapping System with the company's
64 electrode IntellaMap Orion Mapping Catheter, which has also received CE
Mark approval. The combination, part of the 2012 Rhythmia Medical
acquisition, is designed to provide electrophysiologists with accurate,
high-resolution electro-anatomical maps.
"In a pair of independent clinical studies, we repeatedly showed that the
Rhythmia Mapping System can rapidly generate and display high density
electro-anatomical maps that allowed clinicians to effectively diagnose and
treat even the most complex patients," said Hiroshi Nakagawa, M.D., PhD,
professor of Medicine, director, Clinical Catheter Ablation Program,
University of Oklahoma Health Sciences Center, and one of the principle
investigators in the studies. "The IntellaMap Orion Catheter has a
sophisticated 64 electrode design and unique deployable basket that provided a
high degree of maneuverability."
Mapping and navigation systems have become a standard tool for physicians
performing catheter ablations, and current systems demand tradeoffs between
accuracy and speed. A more accurate, high resolution image may improve a
physician's ability to select the appropriate site to ablate, improving
procedural efficacy. Similarly, increasing the speed at which a mapping
system can provide a high resolution map may significantly reduce procedure
time. The Rhythmia Mapping System is designed to increase speed and improve
density of mapping compared to existing systems, potentially offering
significant benefit to patients, physicians and health care systems.
"We believe the Rhythmia Mapping System can become a leader in EP mapping with
unparalleled speed, clarity and simplicity which should enable
electrophysiologists to perform procedures with great efficiency and
precision," said Pete Sommerness, general manager, Electrophysiology, Boston
Scientific. "Bringing the Rhythmia system to our electrophysiology customers
is a major step toward realizing our vision to redefine ablation technology."
In the United States, the Rhythmia Mapping System is an investigational device
and not available for sale.
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