Erkki Liikanen, enterprise commissioner at the European Commission in Brussels, Belgium, has emphasized in a presentation to the European Parliament that the commission has legal competency to ensure that medical devices circulating in the European Union are safe. The whole question of the quality of products is up for review in the context of the upcoming five-year review of the Medical Device Directive.

New measures tightening requirements for silicone gel breast implants are due to be published by the European Commission in June. A final chapter covering informed patient consent is being drafted, according to Antonio Lacerda of the commission.

There have been major concerns about silicone gel implants in both Europe and the U.S. since the early 1990s. In 1995, France became the first and only EU country to ban non-saline breast implants, and has since then pressured the rest of the EU to tighten regulations, with some success. Spain now has introduced a protocol on the use of silicone gel implants and the UK has introduced a centralized registry system.

A specially created subcommittee of the European Parliament has completed a review of the situation and in its report said that more studies were needed to assess associated risks. The report, however, opposed a complete ban.

While it is unlikely that the European Commission will follow France in banning silicone gel implants completely, the European Parliament is expected to press for the new restrictions to be mandatory (in commission parlance, a "Decision") rather than merely advisory and interpretive, the format which at the moment seems the likely outcome.

Jenoptik projects 25% sales growth in 2001

A rare East German success story, Jenoptik (Jena, Germany) has transformed itself from a conglomerate dependent on business in the former Soviet bloc into a high-tech company making lasers, optical and photomechanical products as well as "clean room" facilities.

On the basis of a successful first quarter and a large order backlog, Jenoptik is forecasting 25% sales growth and a 30% increase in income for the full year. The company reported record profits for 2000, up 64% to $49 million. "In fiscal 2000, we earned as much as we did in the past five fiscal years combined," said Chief Executive Lothar Spath.

Spectral endotoxin test in successful trials

Results from trials in 10 intensive care units (ICUs) in Belgium, Canada, the UK and the U.S. showed a negative predictive value greater than 90% for the presence of gram-negative bacteria through use of an assay developed by Spectral Diagnostics (Toronto, Ontario).

The assay measures endotoxin levels in whole blood and provides results in one hour, compared to 24 to 72 hours using traditional culture-based methods. Gram-negative bacteria account for about 60% of systemic infections in patients admitted to ICUs, with a mortality level of around 40%. Rapid identification of gram-negative or gram-positive infections enables a better targeted antibiotic treatment and improved outcome.

Elan (Dublin, Ireland) has the worldwide marketing rights for the endotoxin assay. Spectral Diagnostics said it has filed a modular premarket approval application with the FDA and that it anticipates approval in six to nine months following submission of the trial results.

Sensor-controlled inhalers improve delivery

Profile Therapeutics (Bognor Regis, England) claims greater benefits and reduced drug use with its intelligent adaptive aerosol (AAD) nebulizers. The AAD technology uses sensors incorporated into the device that measure and calculate the patient's breathing pattern and deliver a pre-programmed dose of the prescribed medication during the first half of the inspiration phase of the breathing cycle.

Profile measured the use of its AAD device in 125 children with asthma over a period of six months. Response therapy in terms of day and night asthma symptom scores, exacerbation rates and inflammatory marker activity were assessed. Profile's results showed the AAD system provided "twice the benefit" using a "fraction of the drug" that would have been needed using conventional nebulizers.

Simon Shaw, chief operating officer at Profile Therapeutics, explained that conventional nebulizers release the drug continuously throughout both inspiration and expiration phases of the respiratory cycle. He said that using the AAD device "ensures maximum penetration."

The company expects its first AAD product to be launched in Europe in 2002 in conjunction with a relevant medication for treating cystic fibrosis patients. Rollout in the U.S. will follow thereafter, Shaw said.

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