FDA Clears Siemens' Artis Q and Artis Q.zen Angiography Systems

March 7, 2013—Siemens Healthcare (Malvern, PA) announced that the US Food and Drug Administration (FDA) has cleared the company's Artis Q and Artis Q.zen angiography system families, which feature the company's new x-ray tube and detector technology designed to improve minimally invasive therapy of diseases such as coronary artery disease, stroke, and cancer. These systems feature flat emitters that enable smaller quadratic focal spots that lead to improved visibility of small vessels by as much as 70% compared to conventional technology and provide a high level of detailed imaging information.

According to Siemens' press release, the Artis Q.zen system family combines the new x-ray tube with a new detector technology to enable detection at ultra-low radiation levels. Artis Q.zen imaging can utilize doses as low as half the standard levels applied in angiography. The systems incorporate a fundamental change in detector design from amorphous silicon to a more homogenous crystalline silicon structure. This structure allows for more effective signal amplification and reduced electronic noise, even at ultra-low radiation doses.

Additionally, the Artis Q and Artis Q.zen system families' software applications are designed to improve interventional imaging. In the treatment of coronary artery disease, the new integrated intravascular ultrasound map application automatically and precisely coregisters intravascular ultrasound images and angiography images, providing data such as vessel, lumen, and wall structure. The Clearstent Live allows for imaging of stents with motion stabilization in real time by freezing motion in the region defined by the balloon markers.

Other new 3D applications allow for imaging of the smallest structures inside the head. The systems' high spatial resolution allows for imaging intracranial stents or other miniscule structures, such as the cochlea of the inner ear. Moving organs such as the lungs can be imaged in 3D in less than 3 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' functional 3D imaging provides a basis for planning therapies such as chemoembolization of hepatic tumors, stated the company.