Medical Device Daily Contributing Writer
and Staff Reports

Use of antibiotics in France fell again in 2006 to 33.6 million prescriptions, down 17% since the government launched a program in 2002 to discourage the heavy usage in that country. Yet with the rate of decrease stabilizing at 3.5% per year for the last three years, according to the Caisse Nationale d'Assurance Maladie des Travailleurs Salari s (CNAMTS), the target of a 25% reduction by 2008 is far from assured.

CNAMTS is re-launching its effective media campaign, "Les antibiotiques, c'est pas automatique," which was seen as producing a 7.3% decrease during the first year of the program. The agency also plans another round of visits with general practitioners, putting an emphasis on pediatric practices.

France is Europe's second-heaviest user of antibiotics after Greece and is only slightly ahead of the U.S., which ranks third in the 2005 data gathered for the European Surveillance of Antimicrobial Consumption (ESAC).

While the program has saved France 1566 million ($736 million) since 2002, the driving force behind the government's program is the alarming increase in bacterial resistance. In 2004, France recorded 38% resistance of pneumococcus to penicillin, compared to a European average of 10%. Pneumococcus resistance to erythromycine was 42% compared to 18% for the rest of Europe.

The most significant change in antibiotics consumption is a decrease of 31% for children under five-years-old, the age group that most often is administered antibiotics, according to CNAMTS.

The Netherlands and Germany are among the lowest antibiotic prescribing countries of Europe with about 10 Daily Delivered Doses (DDD) per 1,000 inhabitants in 2005, according to ESAC. The European average is just under 20 DDD, compared to 25 DDD for the U.S.

Studies eye Fabry disease stroke link

In Europe, more than 1.2 million people experience a stroke every year. The 18-to-55 age group is commonly affected, but in 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 [a] 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.

New distribution accord for Misonix

Misonix (Farmingdale, New York) said that it has further expanded its European business of High Intensity Focused Ultrasound (HIFU) using the Sonablate 500 for prostate cancer treatment through a distribution agreement with Takai Hospital Supply (THSI; Tokyo) to market the SB500 in Turkey, Greece and Cyprus.

The SB500 is a medical device developed by Focus Surgery (Indianapolis) and manufactured by Misonix. Misonix also has the exclusive European distribution rights for the product.

Misonix is an investor in privately held Focus Surgery, which it refers to as "one of the most prominent developers of HIFU in the world."

THSI also is an investor in Focus Surgery and has the exclusive rights to market the SB500 in Asia, Australia, Japan and part of the Middle East, where it has been successfully distributing the product since 2001, including the product's first international shipment.

THSI has more than 30 years of experience as a medical device distributor. It specializes in sales of urology products.

Michael McManus Jr., president/CEO of Misonix, said, "THSI has a proven track record in marketing the SB500, with over 2,500 procedures to their credit. This experience should enable accelerated demand creation in Turkey, Greece and Cyprus as we bring to these countries a product that delivers superior prostate cancer treatment and patient recovery."

Occulus in European distribution agreement

Oculus Innovative Sciences (Petaluma, California) said that its subsidiary, Oculus Innovative Sciences Netherlands (Sittard, the Netherlands), and Dancohr, a manufacturer and wholesaler of cosmetics and salon equipment to beauty, manicure, pedicure and hair dressing professionals, have entered into an exclusive agreement for Dancohr to distribute Courtin super-oxidized solution formulated with Oculus' Microcyn Technology in the UK, the Netherlands and other European Union member states.

Dancohr will distribute Oculus' Microcyn Technology under the brand name Courtin to Dancohr's network of cosmetology professionals. The terms of the agreement provide for minimum purchases by Dancohr of about $10 million of Oculus' product over the five-year term of the agreement, with the majority of payments to be made in the final three years of the agreement.

Courtin is used in Europe for cleaning the skin during or after cosmetic handling of feet and hands and was developed using Oculus' Microcyn Technology platform, a super-oxidized, water-based solution.