FDA provides marketing clearance for Siemens' 64-slice and open CT systems

Malvern 12 April 2004The U.S. Food and Drug Administration has provided 510(k) clearance for the world's fastest 64-slice and the world's first open 16-slice CT systems. Developed by Siemens Medical Solutions, the SOMATOM Sensation 64 and SOMATOM Sensation Open are expected to change the role of CT in medical diagnosis and clinical care. The SOMATOM Sensation 64 provides 64-slice sub-millimeter imaging per rotation and the world's fastest gantry rotation time at 0.37 second, for unprecedented speed and sub-millimeter volume coverage, thus allowing physicians to make more informed diagnosis and treatment decisions. The new system also routinely delivers unmatched image quality in cardiac, neurology and body imaging applications with an isotropic spatial resolution of 0.4 mm.

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With an 82-centimeter extended field of view and 82-centimeter large gantry bore, the SOMATOM Sensation Open is designed to facilitate improved patient accessibility and positioning. As the first open 16-slice system, the product enables new levels of diagnostic support for CT-based radiation treatment planning, trauma applications, interventional procedures, and imaging of bariatric patients.

"Siemens has consistently taken the lead in the development of the most advanced CT innovations available on the market today, and specifically has addressed customer demand for faster, more accurate and efficient CT technologies", stated Richard Hausmann, Ph.D., president, CT Division, Siemens Medical Solutions. "The SOMATOM Sensation 64 and SOMATOM Sensation Open represent huge advancements in CT by revolutionizing patient access and positioning, advancing speed and image quality, and ultimately enabling improved clinical work flow and efficiency."

The SOMATOM Sensation 64 sets new benchmarks in image quality and is designed to offer significant improvement in acquisition time and resolution, which are key for cardiac, vascular, neurology and emergency examinations. The increased speed also facilitates data acquisition for patients who have difficulty holding their breath, such as elderly or paediatric patients.

Acquisition of 64 slices per rotation is possible through the new STRATON X-ray tube's "Double z-Sampling" technology, and new Siemens proprietary detector technology. "Double z-Sampling" allows two focal points in the anode by precise deflection of the electron beam within the X-ray tube that generate two overlapping beams to pass the scan field. The double readout of the detector produces 64 slice projections at down to 0.3 mm slice distance, thus increasing spatial resolution and providing unprecedented image quality.

Developed with Speed4D Technology, the SOMATOM Sensation 64 includes WorkStream4D for work flow optimization and data handling, syngo InSpace4D for evaluation of the moving heart, and CARE Dose4D for automated real-time dose adaptation. These components enable advanced utilization of cutting-edge multi-slice CT technology and efficient integration of sophisticated imaging applications in daily clinical practice. "Due to its speed, the SOMATOM Sensation 64 stands alone in its ability to image the finest cardiac structures in detail without motion artifacts, even in those patients with higher heart rates", stated Richard Hausmann.

The extended field of view of the SOMATOM Sensation Open allows visualization of the anatomy outside the conventional 50-centimeter diagnostic field of view to optimize CT-based radiation therapy planning (RTP). Physicians can more accurately plan treatment to the targeted area of the body while minimizing dose to surrounding healthy tissues.

When performing interventional CT procedures, the system's easy patient access enables faster and safer positioning of interventional equipment. During emergency room examinations, the large bore of the open system virtually eliminates the necessity to reposition and adjust life support equipment. Additionally, positioning and imaging of bariatric patients is simplified with the large bore and extended visualization.

"The SOMATOM Sensation Open represents a special CT solution that enables faster examinations in acute settings where every minute matters, and that can enhance work flow in virtually all applications where patient positioning is a challenge", stated Richard Hausmann. Based on Siemens' advanced 16-slice technology and with 0.5 second gantry rotation speed, the SOMATOM Sensation Open incorporates the revolutionary, compact STRATON X-ray tube from Siemens, which cools in less than 20 seconds.

Siemens Medical Solutions of Siemens AG, with headquarters in Malvern, Pennsylvania and Erlangen, Germany, is one of the largest suppliers to the health care industry in the world. The company is known for bringing together innovative medical technologies, health care information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Employing approximately 31.000 people worldwide and operating in more than 120 countries, Siemens Medical Solutions reported sales of 7,4 billion euro, orders of 7,8 billion euro and group profit of 1,1 billion euro for fiscal 2003.


Leslie Versweyveld

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