FDA Clears GE Healthcare's Vivid E9 BT12 Ultrasound System With 4D TEE Transducer

April 25, 2012—GE Healthcare (Waukesha, WI) announced that it has received marketing clearance from the US Food and Drug Administration for the latest version of its Vivid E9 cardiovascular ultrasound system, the Vivid E9 Breakthrough 2012 (BT12), which includes a four-dimensional (4D) transducer for transesophageal echocardiography (TEE). The Vivid E9 BT12 system is now available in the United States, as well as in Europe and other international markets recognizing CE Mark approval.

According to GE Healthcare, whereas the Vivid E9 system is used most frequently in the echo lab, the Vivid E9 BT12 system can also be used in other settings. The TEE transducer produces precise images of the heart for assessment and diagnosis performed in the echo lab, as well as for supporting image-guided procedures in the catheterization lab and invasive surgical procedures in the operating room. With the TEE transducer, Vivid E9 BT12 can be used during procedures including mitral valve repair, transcatheter aortic valve repair, atrial septal defect closure, and patent foramen ovale closure.

The company stated that in addition to the configurable TEE transducer, other Vivid E9 BT12 features that can enhance 4D imaging and workflow include a new tilt and rotate function and a live 2-Click Crop tool. Workflow can be improved during mitral valve acquisition with a dedicated mitral valve button. Advanced quantification is gained with the new TomTec MV Assessment software plug-in (TomTec Imaging Systems GmbH, Unterschleissheim, Germany), which is available on the EchoPAC BT12, to increase productivity during mitral valve assessment and provide a set of static and dynamic measurements of the mitral valve anatomy.

“The new 4D transesophageal probe developed by GE Healthcare is an advanced diagnostic tool,” commented Luigi P. Badano, MD. “It combines ease-of-use and flexibility to acquire 4D data sets, user-friendly navigation tools that allow users to quickly visualize the cardiac structure of interest, and effective quantification software to quantitate left ventricular pump function, myocardial deformation, and mitral valve morphology.”

Prof. Reidar Winter, MD, added, “Vivid E9 BT12 with the new 4D TEE probe has worked great, especially during our intense first 2 days of MitraClip (Abbott Vascular, Santa Clara, CA) procedures. The system has tools like biplane prepare, biplane tilt/rotate, and laser lines that help optimize guidance of the catheter septal puncture, as well as the mitral clip positioning, which has the potential to reduce procedure time.”