Boston Scientific treats 1st patient in Zero AF trial, aims for FDA win for Blazer catheter

January 16, 2013 by MassDevice staff

Medical device giant Boston Scientific treats the 1st patient in a clinical trial of its Blazer open-irrigated temperature ablation catheter, hoping to use the results to win FDA clearance to treat patients with heart rhythm disorders.

Boston Scientific logo

Massachusetts medical device giant Boston Scientific (NYSE:BSX) launched a new study of its Blazer Open-Irrigated Temperature Ablation Catheter, hoping to use the results to win FDA approval.

The 1st patient was treated with the device, the latest in Boston Scientific's Blazer line and the company's 1st open-irrigated catheter, at St. David's Medical Center in Austin, Texas, by Dr. David Burkhardt, who said treatment with the new device was "consistent with my previous experience using other Boston Scientific Blazer catheters," according to a press release.

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Boston Scientific hopes its Zero AF study will enroll up to 472 patients across 33 sites in the U.S., Europe and Asia-Pacific. The device maker is assessing the Blazer device in treatment of patients with paroxysmal atrial fibrillation, a form of atrial fibrillation marked by erratic heart rhythms that start and stop sporadicly.

The Blazer Open-Irrigated Temperature Ablation Catheter delivers electrical energy to heart tissues in efforts to relieve the irregular heart rhythms, and is a common treatment for paroxysmal atrial fibrillation and many other heart rhythm disorders, according to Boston Scientific.

The device is already approved for use in CE Mark countries as well as in Canada.