FDA Clears Siemens Angiography System Families

The Food and Drug Administration (FDA) has cleared Siemens Healthcare’s Artis Q and Artis Q.zen angiography system families, which feature new X-ray tube and detector technology designed for minimally invasive therapy of diseases such as coronary artery disease (CAD), stroke, and cancer. The new X-ray tube in both the Artis Q and Artis Q.zen can help physicians identify small vessels up to 70 percent better than conventional X-ray tube technology, the company says.

In lieu of the coiled filaments found in conventional X-ray tubes, Siemens uses second-generation flat emitter technology in the new X-ray tube of the Artis Q and Artis Q.zen product lines. These flat emitters enable smaller quadratic focal spots that lead to improved visibility of small vessels and a high level of detailed imaging information.

The Artis Q.zen combines the new X-ray tube with a new detector technology that enables detection at lower radiation levels. Artis Q.zen imaging can use doses as low as half the standard levels applied in angiography. This is the result of several innovations, including a fundamental change in detector design from amorphous silicon to a more homogenous crystalline silicon structure. This structure allows for more effective signal amplification, significantly reducing electronic noise even at very low radiation doses.

Siemens developed the Artis Q.zen system family to support better imaging quality at ultra-low-dose ranges, reducing radiation exposure for patients, physicians, and medical staff, which is particularly important in dose-sensitive application fields such as pediatric cardiology and radiology, or electrophysiology.

The Artis Q and Artis Q.zen system families come with software applications designed to improve interventional imaging. In the treatment of CAD, the new integrated IVUS (intravascular ultrasound) map application automatically co-registers IVUS images and angiography images, adding detailed IVUS data such as vessel, lumen and wall structure. CLEARstent Live also allows the cardiologist to image stents with motion stabilization in real time by freezing motion in the region defined by the balloon markers.

Other new 3D applications are designed to image the smallest structures inside the head, such as intracranial stents or the cochlea of the inner ear. Moving organs such as the lungs can be imaged in 3D in less than three seconds, reducing motion artifacts and the required amount of contrast agent. Through visualization and measurement of blood volumes in the liver or other organs, Siemens’ 3D imaging can provide a basis for planning therapies such as chemoembolization and hepatic tumors.