A Diagnostics & Imaging Week

In Europe, more than 1.2 million people experience a stroke every year. The 18-to-55 age group is commonly affected, but at least one-fourth of all cases the causes of stroke in that group remain unclear.

Recent studies have suggested that Fabry disease, an inherited metabolic disorder, is a crucial trigger for stroke in such patients. The role of the disease is now being examined in the international Stroke in Young Fabry Patients (SIFAP) study under the direction of Dr. Arndt Rolfs, vice director of the department of neurology at the University of Rostock (Rostock, Germany).

Stroke is a more frequent problem in young people than commonly realized, with about 15% of all stroke patients being under 55. A recent study on stroke in that age group revealed that about 5% of males and some 3% of females with cryptogenic stroke — stroke of unknown origin — suffer from Fabry disease.

Fabry disease is an inherited, lysosomal storage disorder. Patients produce insufficient amounts of or completely lack alpha-galactosidase A, an enzyme that is essential for breaking down certain fatty substances, especially globotriaosylceramide (Gb-3).

“It is essential for young people with stroke to be screened for Fabry disease as possible trigger,” Rolfs said at an international press conference on SIFAP held in Berlin. “The study will not only provide reliable data on the link between Fabry disease and stroke, but will also help to improve the quality of life of Fabry patients.”

SIFAP is a joint project of more than 30 European stroke units. In the first phase of the study (SIFAP 1), 5,000 young stroke patients will be examined for risk factors, clinical symptoms and possible triggers. Rolfs said the collected data will allow precise conclusions about the prevalence of Fabry disease in young patients.

A concurrent study (SIFAP 2) examines the efficacy of prophylactic and therapeutic measures for stroke patients with Fabry disease.

Screening program set for MCADD

All babies in England are to be screened for an inherited metabolic disease called Medium Chain Acyl CoA Dehydrogenase Deficiency (MCADD), within two weeks of birth, according to a recent announcement by the UK Department of Health.

There will be a planned rollout of the screening program over the next two years.

Health Minister Ivan Lewis said the check will be carried out as part of the standard “heel-prick” test for babies that screens for other diseases such as sickle cell disorders and congenital hypothyroidism.

MCADD is a rare inherited metabolic disease that reduces the ability to maintain a normal blood sugar during episodes of metabolic stress. It affects between one in 10,000 and one in 20,000 babies born in the UK and screening should identify around 28 cases a year in England, Lewis said.

If the disease is not identified at an early stage, around a quarter of affected children will die from the condition, with one-third of survivors sustaining significant neurological damage. The Department of Health said that once babies are identified and given simple treatment, the risk of acute, life-threatening episodes needing emergency and intensive care and of death is substantially reduced.

Sheila Shribman, national clinical director for children, said, “This is a very important screening program. Evidence shows that screening newborn babies for this condition will not only save lives, but can significantly improve their quality of life. Simple treatment through dietary management will substantially reduce the risk of death and the risk of acute, serious illness.”

Sartorius acquires control of Stedim

Sartorius (Goettingen, Germany), a laboratory and process equipment provider, has acquired control of Stedim (Aubagne, France), a manufacturer of disposable bag and freeze-thaw technology systems for biopharmaceutical applications.

Under the terms of the agreement, the two founders of Stedim, who hold 51% of the company, will sell a controlling interest to Sartorius at 43 euros per share. Sartorius will make a public tender offer to acquire all outstanding Stedim shares at the same price. The transaction is subject to approval by Stedim’s shareholders and is expected to be completed this summer.

Sartorius said it will carve out its biotechnology division into a new legal entity to be called Sartorius Stedim Biotech that will be listed on Euronext Paris and is valued at 550 million euros ($715 million), with pro forma sales for 2007 of more than 400 million euros ($520 million) and a 14% EBITDA margin.

Dr. Joachim Kreuzburg, CEO and chairman of the executive board of Sartorius, said in a statement, “Given the strong growth rates in the biopharmaceutical markets and the shift in our markets toward disposable solutions, this transaction significantly accelerates our strategy toward next-generation biopharmaceutical manufacturing.”

Sartorius reported revenues of 521 million euros ($677 million) in 2006, with 48% coming from sales of mechatronics (high-precision weighing technology) and 52% of sales in biotechnology filtration and fermentation products

Stedim had 2006 sales of 91.4 million euros ($119 million), 44% of which were generated in North America. In addition to disposable bag systems, the company offers door systems for aseptic transfer technology and a proprietary freeze-thaw technology.

Austrian hospital orders Elektra systems

Elekta (Stockholm, Sweden), a manufacturer of advanced radiation treatment devices for cancer and brain disorders, reported an order from Landeskrankenhaus Feldkirch (Feldkirch, Austria). It includes two Elekta Synergy advanced treatment systems for intensity-modulated and image-guided radiation therapy (IMRT & IGRT), along with Mosaic, an oncology information management software package from Impac Medical Systems (Mountain View, California), an Elekta company. The total contract is valued at over 8 M euros and includes a service contract spanning over the equipment’s entire expected lifetime.

The radiation oncology department at Landeskrankenhaus Feldkirch offers radiation therapy for about 1,000 patients annually. With the late-2007 installation of the two new Elekta Synergy systems equipped with integrated high-resolution 3-D X-ray volume imaging capability for IGRT, along with advanced IMRT, the radiation oncology department in Feldkirch can now offer these methods for irradiating tumors with extremely high precision and accuracy. The initial order was booked by Elekta in January, and the installation will begin near the end of 2007.

The hospital also will install Mosaiq on more than 30 workstations, allowing the streamlining of processes and sharing of information entered into the EMRs.

Landeskrankenhaus Feldkirch is the main regional healthcare center for the Austrian Federal State of Vorarlberg. IT serves an area of about 400,000 inhabitants in the western-most state of Austria bordering Liechtenstein, Switzerland and Germany.