Siemens Announces FDA Clearance of ACUSON SC2000 Prime Ultrasound System
· System’s new 3D transesophageal probe enables true volume color Doppler visualization of blood flow during interventional valve procedures
· New automated valve analysis software delivers comprehensive valve measurements within seconds to support heart interventions
Siemens Healthcare has announced that the Food and Drug Administration (FDA) has cleared the new Prime edition of its ACUSON SC2000 premium cardiovascular imaging system – a pioneering system 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. 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 3D TEE with 90° x 90° real-time acquisition and full-volume color Doppler, enabling complete 3D 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, MD, associate professor of medicine at Yale University, New Haven, Conn.¹ “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.² 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,” says 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, are also available as an upgrade for users of previous versions of the ACUSON SC2000 system.
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510(k) cleared. The aforementioned products and features are not commercially available in all countries. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.
Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world’s largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of combined cycle turbines for power generation, a leading provider of power transmission solutions and a pioneer in infrastructure solutions and automation and software solutions for industry. The company is also a leading supplier of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2013, which ended on September 30, 2013, revenue from continuing operations totaled €75.9 billion and income from continuing operations €4.2 billion. At the end of September 2013, Siemens had around 362,000 employees worldwide on the basis of continuing operations. Further information is available on the Internet at www.siemens.com.
1Dr. Lissa Sugeng is employed by an institution that provides Siemens product reference services for compensation pursuant to a written agreement.
2Results may vary. Data on file.