News Story

Running the Numbers
Angio Suites Add Tools for the Interventional Radiologist
Product Showcase: Mobile DR System Displays Images in 3 Seconds
GE OEC Medical Signs Consent Decree with FDA
Product Showcase: Image-Enhancement Software Analyzes Every Pixel

The Innova 3131IQ digital flat-panel biplane imaging system from GE Healthcare covers the full size of the patient?s frontal and lateral anatomy simultaneously, enabling procedures to be performed with fewer x-ray images and fewer contrast injections.

Angio Suites Add Tools for the Interventional Radiologist

Flat panels and portability were the buzzwords at RSNA 2006 as vendors displayed the latest advances in their angiographic x-ray technology.

The Innova 3131IQ and 2121IQ Biplane Imaging Systems from GE Healthcare, Waukesha, Wis?which were built based on input from dozens of clinical studies?feature proprietary digital flat-panel technology that enables high-quality 3D flat-panel rotational imaging of the vascular system, bone, and soft tissue. Offering 20- and 30-cm area coverage, the Innova IQ systems illuminate the finest vessel and cardiovascular technology while covering the full size of the patient?s lateral and frontal anatomy simultaneously.

This angiographic 3D image of a high-grade stenosis of the left internal carotid artery in a 79-year-old male was acquired on the Siemens Axiom Artis dBA Twin system using syngo Inspace 3D and cross-sectional visualization by syngo DynaCT to evaluate stent deployment. Image courtesy of Siemens Medical Solutions and University Hospital of Erlangen-Nuremberg, Germany.

Siemens Medical Solutions, Malvern, Pa, unveiled the largest biplane anatomical coverage area on the market?30 x 40 cm?on its Axiom Artis dBA Twin system. Featuring a compact housing design that enables virtually unrestricted patient access and outstanding angulation capabilities, the Axiom Artis dBA Twin offers flexibility across an array of applications. It also facilitates dose reduction for pediatric applications and supports the latest cross-sectioning 3D imaging techniques via the optional syngo DynaCT cross-sectional imaging capability.

Specializing in C-arm systems, Ziehm Imaging Inc, Riverside, Calif, displayed its Vision FD, Vision R, and Vario 3D devices, all of which were cleared by the FDA in 2006. The Vision R features a high-dynamic CCD camera running in pulse mode with up to 30 frames per second. The Vario 3D alternates between routine 2D fluoroscopy and isocentric or 3D mode with a simple keystroke; the full array of routine fluoroscopy applications is available on the device, making it a cost-efficient choice for hospitals where 3D is a necessity. And one of the first mobile C-arms to use flat-panel-detector technology, the Vision FD, is now cleared for use in the United States, moving the same CCD imaging capabilities provided by the Vision R from room to room with ease.

This feature is important in a market where patients are taking a growing interest in the price and quality of their care. “The informed patient understands why flat panel is preferable to analog,” explains Travis Sheridan, director of public relations at Ziehm. “The informed patient now understands the importance of using less radiation to capture a better image.”

? C. Vasko

GE OEC Medical Signs Consent Decree with FDA

After the FDA made its most recent examination of General Electric Co?s Salt Lake City manufacturing facility, the agency issued a consent decree of permanent injunction prohibiting the manufacture and distribution of specified x-ray surgical imaging systems made by GE OEC Medical Systems?a division of GE Healthcare, Waukesha, Wis. The consent decree?filed on January 12?was signed by two of GE?s top executives and also applies to the company?s Lawrence, Mass, facility.

The Utah location?s manufacturing practices came under scrutiny during a November 2004 inspection. The FDA issued a Warning Letter on March 31, 2005, citing violations of its current good manufacturing practice (CGMP) requirements; the injunction followed when a 2006 investigation revealed inadequate responses to the letter. CGMP deficiencies cited included failure to establish and maintain adequate procedures for validating the device design, and failure to establish and maintain adequate procedures for implementing corrective and preventive actions.

“These devices are used on thousands of patients, and their dependability and accuracy are critical for the successful outcomes of important medical procedures,” Daniel Schultz, MD, director of the FDA?s Center for Devices and Radiological Health, said in a press release. “When the FDA?s August 2006 inspection found ongoing CGMP deficiencies at the Utah facility, GE voluntarily stopped distributing devices from that facility and is working with the FDA to ensure that necessary corrective actions are fully implemented.”

The devices affected include the 9900 Elite C-Arm System, the 9900 Elite NAV C-Arm System, the 9800 C-Arm System, the 2800 UroView System, the 6800 MiniView System, the Insta-Trak 3500 NAV System, and the ENTrak 2500 NAV System, as well as their components and accessories. Under the terms of the consent decree?signed by Joseph M. Hogan, president and CEO of GE Healthcare; and Peter McCabe, president and CEO of GE OEC Medical Systems?the companies will take necessary measures to ensure FDA compliance. The decree also requires that the companies hire an independent expert to conduct inspections of the Utah and Massachusetts facilities and certify to FDA that all required corrections have been made.

The consent decree allows the companies to continue to provide routine service, replacement parts, and accessories for existing x-ray surgical systems; however, the companies are required to submit to the FDA a corrective action plan for bringing into compliance the 9900 Elite C-Arm, the 9900 Elite NAV C-Arm, and the 9800 C-Arm systems that currently are in use in the United States.

GE OEC Medical Systems has initiated product recall on several models of its x-ray surgical imaging systems. Copies of the recall notices are available online at www.gehealthcare.com/usen/xr/surgery/oec_info.html.

? C. Vasko