A Medical Device Daily

Pall (Port Washington, New York), a developer of filtration, separation and purification technology reported the opening of its new European headquarters in Fribourg, Switzerland. The office will initially house Pall's Life Sciences business in Europe, with plans to integrate the company's European Industrial business in 2011. The initiative was undertaken with the Fribourg Development Agency (FDA).

"Europe represents approximately 40% of Pall's $2.3 billion revenues worldwide. The Fribourg office will manage the company's continuing growth in the European markets and bring important efficiencies to customers and the business," said Eric Krasnoff, Pall chairman/CEO.

"Fribourg provides a central location, a well educated, multi-lingual workforce and a business-oriented environment that make it ideal as a regional management center. This enables us to centralize key management activities to improve service, increase productivity and lower operating costs," said Roberto Perez, president, Pall Life Sciences.

MagForce submits product file for CE mark

MagForce Nanotechnologies (Berlin) has submitted the product file for NanoTherm to Medcert GmbH, the medical certification and testing company which serves as notified body for the certification of medical products.

With this step, MagForce said it has now commenced the conformity assessment procedure for its Nano-Cancer therapy. Following successful completion of this conformity assessment procedure and EC type testing of the magnetic field applicator, MagForce will be able to apply the CE European conformity marking and to market its Nano-Cancer therapy throughout the European Union.

In early November, the results of a pivotal clinical trial were published demonstrating the efficacy of the new therapy in patients with recurrent glioblastoma, and it is upon these results that the application for European regulatory approval is based. The primary study objective, which was to extend the median survival time following tumor recurrence by three months compared to a historical control group, was significantly exceeded in the actual results. Following treatment with Nano-Cancer and accompanying radiotherapy, the median survival time following diagnosis of the first tumor recurrence was 13.4 months. Compared to the 6.2-month median survival time following recurrence observed in a recently published EORTC study, the patient survival time was shown to be statistically highly significant longer.

"With the glioblastoma study successfully concluded and the product file now submitted for review, we have attained our most important objectives for this year, which we are of course extremely pleased about," said Uwe Maschek, CEO of MagForce Nanotechnologies. "We are confident that we are on a solid course to complete the certification procedure for our Nano-Cancer therapy in the first half of 2010. Over the months ahead, we will thus be able to concentrate our resources entirely on preparations for the commercialization phase."

MagForce develops nanotechnology-based cancer treatment products. Its patented Nano-Cancer therapy allows the targeted destruction of tumors using superparamagnetic nanoparticles to generate heat.

Sectra RIS/PACS now used in Northern Ireland

The South East Trust in Northern Ireland, comprising five hospitals, is live with Sectra (Link ping, Sweden) RIS/PACS. These are the first of 25 hospitals, together performing more than 1 million examinations per year, that will be connected in one common radiology IT solution called NIPACS.

In October 2008, Sectra signed a 31 million contract with the Department of Health to provide an integrated solution for digital management of all radiology information and images throughout the entire public healthcare system in Northern Ireland.

"I have been very impressed by the magnificent equipment which really is of the highest specification, and its proven potential for improving services," says Michael McGimpsey, the Minister for Health, Social Services and Public Safety in Northern Ireland. "This will result in quicker diagnosis and treatment for patients, and will contribute to a much more efficient and productive health and social care system."

Dutch researchers report on RapidArc

Researchers from VU University Medical Center (Amsterdam, the Netherlands), have reported that RapidArc radiotherapy from Varian Medical Systems (Palo Alto, California) has clinical advantages over earlier fixed-beam approaches to stereotactic treatments of lung tumors. Their findings, based on treatment of 85 medically inoperable lung cancer patients, were reported at the recent annual meeting of the American Society for Radiation Oncology (ASTRO; Fairfax, Virginia) in Chicago and a condensed version has been published in the Green Journal' (Radiotherapy and Oncology, 93, 2009).

"RapidArc enabled much faster treatment for these patients, with treatment in just six minutes, reducing the risk of patient motion and achieving superior dose conformity around the target while reducing dose to the chest wall by almost a third," said Wilko Verbakel, a medical physicist. "Dose conformity is extremely important when you are treating close to critical structures and the conformity you see with RapidArc is always better or at least as good as with fixed-beam IMRT and certainly better than achievable with ten static non-coplanar beams or dynamic conformal arc."

Clinicians at VU deliver stereotactic RapidArc treatments using the Novalis Tx radiosurgical platform from Varian and BrainLAB (Feldkirchen, Germany). The high dose delivery capability of Novalis Tx combined with the speed of RapidArc enables stereotactic treatments with beam-on time of as little as six and a half minutes, even for the highest doses, which previously took about 30 minutes to deliver.

Hypo-fractionated stereotactic lung treatments at VU are delivered in three sessions of 18 Gy each, five sessions of 11 Gy each or eight sessions of 7.5 Gy each, depending on the size and position of the tumor. Planning, described by Verbakel as very easy' using RapidArc, is based on 4-D CT scans and the treatment field allows a small margin to account for tumor motion caused by breathing. Additional recent research by the team at VU has shown that, unlike with some other advanced radiation delivery techniques, treatment of a moving tumor with RapidArc has no negative dosimetric consequences.