Cardiac Ablation Device Approved
The Isolator bipolar ablation clamp system manufactured by AtriCure received marketing clearance from the FDA. This adds to the line of products available for cardiac surgery.
The device uses bipolar radiofrequency for cardiac ablation indications. The FDA approval also includes the Isolator Synergy ablation clamps that can be used to destroy or ablate soft tissue in cardiac as well as general surgical procedures.
The company’s multifunctional bipolar pen is used for cardiac ablation in addition to treatment of cardiac arrhythmias. Uses for cardiac arrhythmia include temporary pacing, sensing, stimulating, and recording during disease evaluation.
According to AtriCure, this may be the only currently approved device that employs bipolar radiofrequency in a clamp system design for this indication.
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July 10, 2007 Related topics: Product Approval & Certification, Cardiology