FDA clears x-ray angio system, MRI coil, and hybrid CT

April 25, 2001

The vascular community may soon have a new angiography product, now that the FDA has cleared Axiom Artis, an angiography system developed by Siemens Medical Solutions.Siemens isn’t talking, but a 510(k) summary statement, filed with the FDA,

The vascular community may soon have a new angiography product, now that the FDA has cleared Axiom Artis, an angiography system developed by Siemens Medical Solutions.

Siemens isn’t talking, but a 510(k) summary statement, filed with the FDA, describes the product as a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures.

“Axiom Artis can support the acquisition of position-triggered imaging for spatial data synthesis,” according to the summary statement obtained by SCAN. “When equipped with the Axiom OR table from the Koordinat table family, the modular angiography system is suitable for angiographic procedures in operating rooms.”

Siemens provided few details about the fledgling product.

“Delivery time frames are just too far off for us to make a big deal out of this yet,” said Richard Ruoff, the product manager.

According to the FDA summary, the system is designed as a set of components that may be combined in different configurations, creating specialized angiography systems and satisfying patient accessibility requirements for each specialized angiographic application.

The system has three basic stand variations: single-plane floor mounted, second-plane ceiling mounted, and floor-mounted multipurpose. The modified stand designs provide the basic building block that determines selection of the other components, such as the generator, x-ray tube, or collimator.

GE was less hesitant to talk about its FDA clearances. In a decision described by a GE executive as “huge,” the watchdog agency cleared an MRI coil designed to enable GE’s 3-tesla Signa VH/i to complete whole-body scans.

“It’s a very big step for the system,” said David Weber, manager of global MR growth for GE.

The 3-tesla system was introduced in 1996, but only as a head scanner. The body coil has been in the works for several years. Its clearance is the latest in a string of FDA OKs regarding the scanner, including earlier ones for multinuclear spectroscopy, diffusion cancer imaging, and functional MRI.

“This takes our 3-tesla system and allows it to grow up into what it was designed for in the beginning,” Weber said. “I cannot think of a body part that we are not approved for.”

The coil is retrofittable to GE’s installed base of 3-tesla systems. To date, 24 have been installed; 10 more are waiting to be delivered; another 30 to 40 systems are expected to be installed before the end of the year, Weber said.

“We have a very, very aggressive vision for 3 tesla,” Weber said. “We really believe this is the beginning of a new platform for mainstream clinical radiology. We believe this is going to grow into the next 1.5 tesla.”

The FDA also cleared a CT/PET system from GE. The system combines the company’s LightSpeed QX/i CT and Advance NX/i PET scanner into one platform. GE has already begun taking orders for the hybrid product.