Siemens Healthineers receive FDA clearance for new angiography systems

By Staff News Brief

Siemens Healthineers has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the ARTIS icono, a high-precision family of angiography systems. The systems permit a wide range of minimally invasive procedures to be performed in a single interventional suit.

The ARTIS icono floor is a floor-mounted single-plane system for vascular, interventional cardiology, surgical, and oncology procedures. It provides coverage of patients up to 6’8” in height without repositioning and lateral coverage of 6.23 feet. It can achieve virtually the same angles as a ceiling-mounted system and free space for anesthesia carts, echocardiography systems, and patient monitors with its additional axis. The ARTIS icono floor does not require a ceiling-mounted unit.

The ARTIS biplane system is engineered for optimal utilization in neuroradiology and abdominal imaging. It has significantly enhanced two-dimensional and three-dimensional imaging as well as improved visualization of difficult-to-delineate structures. It also provides rapid flexibility for multidisciplinary lab use. Users can shift the detector’s position from the patient’s right side for interventional radiology procedures to the left side for cardiovascular procedures in under 90 seconds using the system’s lateral plane switch.

Siemens Healthineers states in a press release that the ARTIS icono platform delivers the new OPTIQ image chain, which fundamentally redesigns image processing for 2D imaging. OPTIQ increases image quality across a wide range of C-arm angles and patient weights, regulating acquisition parameters to automatically achieve optimal image contrast at patient radiation doses that conform to the As Low As Reasonably Achievable (ALARA) guiding principal for radiation safety.

Case Flows provide personalized workflow plans to optimize imaging parameters and system positions, in addition to displaying layouts for the entire procedure. They are designed to adapt to user needs, providing flexibility when executing certain sequences. Users can standardize procedures across multiple ARTIS icono labs for improved outcomes and more consistent documentation, according to Siemens.

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Siemens Healthineers receive FDA clearance for new angiography systems.  Appl Radiol. 

By Staff News Brief| September 24, 2019
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