Medical Device Dailys

VIENNA, Austria — Ziehm Imaging (Nuremberg, Germany/Riverside, California) announced at ECR 2009 that Stryker (Kalamazoo, Michigan) has joined the list of companies with surgical navigational systems who are integrating 2-D and 3-D image data from the Ziehm mobile C-arms for intraoperative guidance during minimally invasive orthopedic, trauma and spinal surgery.

Ziehm has previously integrated its X-ray platforms with BrainLAB ((Feldkirchen, Germany/ Westchester, Illinois), Praxim (Grenoble, France) and CAS Innovation (Erlangen, Germany), which was acquired by Siemens (Erlangen, Germany) in February 2008.

Stryker will add the capability for real-time imaging of surgery to its active infrared navigation system for surgical planning and guidance.

The first Stryker system using the integrated Ziehm platform was installed at the Neurocenter of the University Medical Center in Freiburg, Germany, and has been used for spinal surgeries.

Dr. Ulrich Hubbe said the open C-arm allows routinely surgical procedures without having to adapt to a new clinical workflow, typically demanded by the introduction of new technology.

Martin Herzmann, director of global marketing for Ziehm Imaging, told Medical Device Daily that 50 C-arm systems have been sold in the 16 months since the company began collaborations on navigational surgery systems.

He said that for hospitals with Zeihm mobile X-ray units that also use a surgical navigation system rom one of the partners, only a software upgrade is required to integrate the two systems.

Until Ziehm began offering X-ray on wheels, surgeons relied on pre-operative and post-operative computed tomography (CT) scans.

With an intraoperative capability, surgeons now load pre-operative images into the navigation system and once the procedure is underway can receive real-time 3-D images that are automatically loaded and calibrated to the imaging on the navigation' systems monitor.

As a result, post-operative CT is often made redundant.

"Our goal is to bring mobile imaging to the same quality standards as fixed systems but at costs far below installed unit," said Herzmann.

"We are talking about mobile X-ray C-arms at $200,000 as opposed to $2 million to install a fixed system," he said.

EU directive would shut down MRI use

Gabriel Krestin, director of the European Institute for Biomedical Imaging Research (EIBIR), is hopping mad about European Union (EU) Physical Agents Directive 2004/40/EC on electromagnetic fields and is running a one-man campaign to stir up radiologists.

An unitended effect of the Directive, which aimed to regulate electromagnetic fields generated by power lines and cell phones is that normal use of magnetic resonance imaging (MRI) would breach the standards set and technically would need to be shut down.

Krestin said successful lobbying by the Alliance for MRI resulted in a postponement of enforcement of the Directive until April 2012, but the problem has not been solved yet because the language has not changed regarding MRIs.

Yet few people seem to take the Directive seriously and even fewer believe the EU rule would cause anyone to switch of their MRI.

EU directives have no force of law and must be adopted by national legislatures in each of the 27 Member States.

Technically the EU can levy a penalty against any country that fails to transpose t Directive 2004/40/EC by 2012, but the EU has yet to penalize any country for exceeding budget deficit limits, a more serious offense as it affects the value of the single currency, the euro.

To date, Krestin reports, only Poland has transposed the Directive into national law.

On the other hand the always sensible Dutch convened a consultation with healthcare workers and radiologists that resulted in a national standard that says there are no limits on exposure levels from MRI and the greatest risk anyone has found from MRI is the potential for injury from flying objects attracted by the giant magnet when it is switched on.

Krestin continues to campaign, however, stating in passionate Brussel-ese, "It will be crucial to raise awareness and ensure commitment of stakeholder groups at the national level and to seek constructive dialogue with the social partners in order to find a workable solution that allows for the continued use of MRI as well as adequate protection of workers."

News from Agfa

Agfa HealthCare (Mortsel, Belgium), a provider of diagnostic imaging and healthcare IT solutions, said at ECR 2009 that it has been selected by ENEL-MED, a private healthcare provider in Poland, to install its IMPAX 6 Picture Archiving and Communications System (PACS) to serve the needs of its seven facilities and more than 360 medical provider customers across Poland.

The agreement also foresees the installation of eight of the company's Computed Radiography (CR) systems and seven Drystar 5302 imagers.

Agfa also said it has signed an agreement with the Bulgarian Ministry of Health to implement IMPAX 6 at four of its sites in that country. To support the hospitals' transformation into digital imaging, Agfa also will install two CR 85-X and four CR 35-X solutions. at the Clinical Center Alexandrowska in Sofia, and the hospitals at Sveta Anna, Blagoevgrad and Stara Zagora.

Lastly, the company reported that it has delivered the first phase of solutions at several of the Basque Healthcare Service's 28-site Osakidetza facilities in Spain, including a go-live of its centralized Radiology Information System (RIS) across the facility's network.

In late 2007, Agfa was selected to install its IMPAX 6 system, a centralized RIS, 59 Computed Radiography solutions, and 52 diagnostic imaging printers across five hospitals and 23 primary care centers in the Basque Country of northern Spain.

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