FDA Clears Siemens’ Acuson SC2000 Prime Ultrasound System

The U.S. Food and Drug Administration (FDA) has cleared Siemens Healthcare’s new Prime edition of its Acuson SC2000 premium cardiovascular imaging system – a product that offers live full-volume color Doppler imaging of heart valve anatomy and blood flow using a new true volume transesophageal echo (TEE) probe.

With this technology, physicians can obtain 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, the company claims. This information helps physicians make faster, more accurate critical decisions.

During 3D TEE imaging, the physician guides a flexible probe into the esophagus to acquire close-range, detailed cardiac images to assess valve function. TEE helps guide placement of devices such as MitraClips and artificial valves during cardiac interventions to correct valve dysfunction.

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. However, the new Z6Ms true volume TEE probe on the Acuson SC2000 Prime is the first Siemens transducer to use true volume 3-D TEE with 90 degrees by 90 degrees real-time acquisition and full-volume color Doppler, enabling complete 3-D images of the heart, in every heartbeat. By eliminating the need for multiple beats to form an image and adding volume color Doppler capabilities, the Z6Ms true volume TEE probe allows the surgeon 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,” says Lissa Sugeng, M.D., associate professor of medicine at Yale University in New Haven, Conn. “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.”

Also introduced on the Acuson SC2000 Prime is the eSie Valves advanced analysis semi-automated software package, which measures heart valves during cardiac procedures. While standard quantification software requires several minutes to provide heart valve measurements, eSie Valves provides semi-automated 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.

“We’re extremely proud of what the Acuson SC2000 Prime enables physicians to do in the detection and treatment of valvular disease,” said Dr. Jeffrey Bundy, CEO, Siemens Ultrasound. “We are aiming to provide tools with standard-setting performance and workflow, equipping physicians to focus on their patients and explore new and more efficacious procedures.”

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