FDA Clears Siemens’ Cardiovascular Ultrasound

The United States Food and Drug Administration (FDA) has cleared the latest cardiovascular ultrasound system by Siemens, ACUSON SC2000 Prime.

The ACUSON SC2000 Prime provides live full-volume color Doppler imaging of heart valve anatomy and blood flow. The system uses a new true volume transesophageal echo (TEE) probe, which Siemens claims allows physicians to obtain a more anatomically accurate single view of the heart and dynamic blood flow during interventional valve procedures. Siemens said physicians can obtain an accurate view even in patients with electrocardiogram abnormalities, a modality known for misdiagnoses.

Current 3D TEE imaging requires stitching, or the fusion of multiple heartbeats, to form a complete image of cardiac function and blood flow, Siemens said. This excludes almost all patients with any ECG abnormalities and often results in image artifacts that may skew results, according to the Siemens release. [[{"type":"media","view_mode":"media_crop","fid":"28585","attributes":{"alt":"Siemens' ACUSON SC2000 Prime Ultrasound","class":"media-image media-image-right","id":"media_crop_1515401746633","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2913","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 227px; width: 200px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":" ","typeof":"foaf:Image"}}]]

Siemens claims the new Z6Ms true volume TEE probe on the ACUSON SC2000 Prime uses true volume 3D TEE with 90° × 90° real-time acquisition and full-volume color Doppler, which enables complete 3D images of the heart in every heartbeat. Eliminating the need for multiple heartbeats to form an image and adding volume color Doppler capabilities enables the surgeon to visualize and assess blood flow and ensure proper function of a repaired or replaced valve in real-time, Siemens said.

“Volume color Doppler is extremely important,” Lissa Sugeng, MD, associate professor of medicine at Yale University, New Haven, CT, said in the 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.”

The ACUSON SC2000 Prime is equipped with the eSie Valves advanced analysis semi-automated software package, which is responsible for measuring heart valves during cardiac procedures, Siemens said. Siemens claims the software provides semi-automated aortic and mitral valve measurements in seconds, compared to the industry standard that requires several minutes.