St. Jude Medical (Little Canada, MN) has announced that its ViewFlex Xtra catheter system has been cleared to be marketed in the European Union. The device is designed for use with the ViewMate Z ultrasound console during intracardiac echocardiography procedures.
According to the company, the new system allows for single-handed use by physicians. In addition to a new ergonomic handle, the device features a four-way tip deflection feature. With the device, physicians can create high-resolution images of a patient’s cardiac anatomy and blood flow in real-time. The catheter’s sister product, the ViewMate Z combination ultrasound and echocardiography device, was developed as a collaborative effort with Zonare Medical Systems, a healthcare company based in Mountain View, CA.
In July of 2012, the ViewFlex Xtra was granted 510(k) clearance for the device from the United States Food and Drug Administration.
Frank Callaghan, the president of the cardiovascular division at St. Jude Medical, said in prepared remarks: "The combination of the ViewFlex Xtra ICE Catheter and ViewMate Z Intracardiac Ultrasound Console in an integrated EP Lab not only yields exceptional images, but more importantly allows physicians to focus on the patient and less on catheter manipulation.”
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