FDA Clears Siemens' Acuson SC2000 Prime Ultrasound System

October 17, 2014—Siemens Healthcare announced that the US Food and Drug Administration (FDA) has cleared the Prime edition of the company’s Acuson SC2000 cardiovascular imaging system. The Prime edition of the system offers live full-volume color Doppler imaging of heart valve anatomy and blood flow using a new true volume transesophageal echo (TEE) probe.

According to the company, the new technology provides a more anatomically accurate view of the heart and dynamic blood flow in one view during interventional valve procedures, even in patients with electrocardiogram (ECG) abnormalities. With this information, physicians can make faster, more accurate critical decisions.

Additionally, the new Z6Ms true volume TEE probe on the Acuson SC2000 Prime is the first Siemens transducer to use true volume three-dimensional (3D) TEE with 90° X 90° real-time acquisition and full-volume color Doppler, enabling complete 3D images of the heart, in every heartbeat.

During 3D TEE imaging, a flexible probe is guided into the esophagus to acquire close-range, detailed cardiac images to assess valve function. TEE also helps guide placement of interventional devices such as MitraClips (Abbott Vascular) and artificial valves during cardiac interventions to correct valve dysfunction.  

Siemens noted that current 3D TEE imaging methods require stitching—the fusion of multiple heartbeats—to form a complete image of cardiac function and blood flow. This gated acquisition eliminates almost all patients with any ECG abnormalities and often results in image artifacts that may skew results.

By eliminating the need for multiple beats to form an image and adding volume color Doppler capabilities, the Z6Ms true volume TEE probe allows physicians to visualize and assess blood flow in real time during a procedure to ensure proper function of the repaired or replaced valve, potentially reducing the need for a secondary intervention to correct any remaining regurgitation or the leakage of blood back into the heart chambers due to a dysfunctional valve.

“Volume color Doppler is extremely important,” commented Lissa Sugeng, MD, in the company’s press release. “With Siemens’ new volume acquisition, I can see the entire valve, locate the regurgitant jet, and assess the size of the orifice very quickly so that we can continue with the procedure.” Dr. Sugeng is associate professor of medicine at Yale University in New Haven, Connecticut.

Also introduced on the Acuson SC2000 Prime, the eSie Valves advanced analysis semiautomated software package measures heart valves during cardiac procedures. Whereas standard quantification software requires several minutes to provide heart valve measurements, the eSie Valves function provides semiautomated aortic and mitral valve measurements in seconds. This quantitative information allows physicians to quickly and easily evaluate valvular anatomy and physiology, which aids in device sizing and surgical repair, stated the company.

Siemens’ new Prime cardiovascular ultrasound technologies, including the Z6Ms true volume TEE transducer and the eSie Valves package, are also available as an upgrade for users of previous versions of the Acuson SC2000 system.