The first patient has been
treated in the Boston Scientific Corporation BSX ZERO AF clinical
trial to evaluate the safety and effectiveness of the Blazer® Open-Irrigated
Temperature Ablation Catheter in patients with symptomatic, drug refractory
paroxysmal atrial fibrillation. This international, multi-center study will
include up to 33 sites in the United States, Europe and Asia-Pacific, and as
many as 472 patients. The results of the ZERO AF trial are expected to be used
to support a U.S. Food and Drug Administration regulatory submission for a
paroxysmal atrial fibrillation indication.
Atrial fibrillation is a disorder that disrupts the ability of the heart to
beat regularly and pump blood efficiently. It affects approximately 15
million people worldwide and can lead to complications such as stroke or heart
failure. Paroxysmal atrial fibrillation is a type of atrial fibrillation in
which the irregular heartbeat starts up very quickly, stops spontaneously and
abruptly returns to the normal rhythm resulting in patients feeling
symptomatic. Catheter ablation, a procedure in which localized electrical
energy is delivered into the heart tissue aimed at restoring the continuous
normal rhythm, is a common treatment for many heart rhythm disorders including
paroxysmal atrial fibrillation.
The Blazer Open-Irrigated Catheter is the latest addition to the extended
families of Boston Scientific Blazer catheters. It is the company's first
entry into the open-irrigated catheter segment and is approved for use in CE
Mark countries and Canada. The Blazer Open-Irrigated Catheter offers the
Total Tip Cooling™ design, engineered to consistently cool the entire tip of
the electrode during radiofrequency energy delivery.
The first U.S. procedure was performed at St. David's Medical Center in Austin
by J. David Burkhardt, M.D., also part of Texas Cardiac Arrhythmia. "As
expected, the Blazer Open-Irrigated catheter handled well, consistent with my
previous experience using other Boston Scientific Blazer catheters," said Dr.
Burkhardt.
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