FDA Clears Siemens' Artis One Angiography System

May 5, 2014—Siemens Healthcare announced that the US Food and Drug Administration (FDA) has cleared the Artis One angiography system, which is designed for routine interventions including revascularizations of peripheral vessel occlusions, functional tests of dialysis shunts in patients with kidney failure, diagnostic or minimally invasive angiographic treatment of narrowed coronary arteries, and pacemaker implantations.

According to Siemens, the floor-mounted Artis One provides positioning flexibility similar to ceiling-mounted systems and occupies just 269 square feet, compared to the standard 484 square feet required by ceiling-mounted systems.

The company noted that the system features several axes that can move independently of one another, enabling physicians and hospital staff to easily position the system where it is needed—regardless of where they stand. The system accommodates full head-to-toe coverage of patients up to 6 feet, 10 inches in height without the need for patient repositioning. The system allows free access to the patient's head, enabling optimal care during the procedure.

The system’s tableside console has tactile buttons that can be manipulated easily even under the sterile covering. The on-screen, menu-guided user interface allows the physician to navigate directly using the heads-up display. All information regarding the procedure remains directly in front of the operator. The Artis One’s 30-inch display size delivers images up to 90% larger than conventional 19-inch monitors.

The Artis One features the Clearstent Live application for interventional cardiology procedures. This freezes motion in the region of the stent, allowing the interventionist to mask out movement of the beating heart and place the stent in precisely the correct position. The Artis One also includes HeartSweep, which uses dual-axis rotational angiography to image the entire heart in a single, smooth C-arm movement instead of multiple acquisitions from different projections. This single-sweep movement has the potential to speed up procedures and save contrast agents. The Artis One uses approximately 20% less energy than Siemens’ Artis Zee floor system, which can help reduce operational costs. The Artis One angiography system is available in multiple configurations that are tailored to fit a broad range of clinical requirements, stated Siemens Healthcare.