From 20–24 March 2007 an expected 1700 exhibitors from more than 50 countries will gather on 130000 sqm2 of exhibition space at the Koelnmesse venue in Cologne for the International Dental Show (IDS). This key trade fair takes place every second year and showcases the latest products and innovations from dental manufacturers in Europe and around the world.
"The German and international dental manufacturers recognize that they can utilize this exceptionally well-organized event to present of their innovations to the best advantage," said Burkhard Sticklies from the Verband der Deutschen Dental-Industrie (VDDI). The event is also well attended by the German and international dental press, using the opportunity to meet contacts and stay abreast with advances in dental technology. "For both exhibitors and visitors, the IDS is an outstanding event with a high level of experiential significance. Product demonstrations at the exhibition stands, demonstrations and practical shoptalk, as well as intensive discussions and meetings, shape the character of the IDS. We wish many good meetings, informative discussions and an excellent, successful exhibition to all exhibitors and visitors alike!" Sticklies added.
www.koelnmesse.de/wEnglisch/ids/index.htm|~
1st European Accuitomo forum
One of the hot topics at the 2007 International Dental Show (IDS), Cologne, Germany, will be 3D volume tomography and J. Morita Europe GmbH spearheads the event with an international panel discussion on the subject. Six well-known experts from the academic world and dental practice will report on their experience with 3D volume tomography in general, and with Morita's 3D Accuitomo in particular, on 20 March 2007.
The presentations cover all key points of interest in dentistry and ENT treatment. Other manufacturers will be presenting their systems alongside Morita, making it beneficial to attend the Morita forum, to make comparisons, exchange views with experts.
According to Morita, the Accuitomo was the first effective 3D volume tomography system with high-resolution cone-beam computed tomography (CBCT), and is now the gold standard for resolution and image quality. The 3D Accuitomo FPD works with an image enhancer, which captures the cumulative images generated by x-ray, and stores them as they are taken. A computer transforms this raw data into very high-resolution 3D records, which can be cut along any spatial plane and viewed in real time. The 60 × 60 mm flat-panel detector generates images of outstanding quality with visibly improved contrast resolution, which cannot be achieved with other imaging techniques such as CT.
www.jmoritaeurope.com|~
Periowave clinical outcomes
Ondine Biopharma, Canada, has announced it will present clinical trial abstracts on its Periowave system at the combined meetings of the International Association for Dental Research (IADR) and the American Association for Dental Research in New Orleans, USA, 21–24 March 2007.
The data will summarize the results from a clinical trial of the periodontal treatment system which was conducted in collaboration with the Loma Linda University School of Dentistry, California, USA. Results of the blinded, randomized, controlled study showed good clinical efficacy and no related adverse effects. A total of 75% of the patients enrolled in the Periowave treatment arm showed greater than 2 mm reduction in pocket depth, compared to just 20% in the scaling and root planing arm.
Periowave is a photodynamic disinfection system that uses low-intensity lasers and wavelength-specific, light-activated compounds to specifically target and destroy microbial pathogens and reduce the symptoms of periodontal disease.
www.periowave.com|~
Excellence in quality management
The first European dental company to be awarded the seal of quality of the European Foundation for Quality Management (EFQM) is GC Europe. The company accepted its 'Committed to Excellence' certificate in December 2006 at its headquarters in Leuven, Belgium.
The application for this award involved a year of intensive preparation, including self-assessments by all staff members based on EFQM checklists. From these, GC Europe analysed its strengths and weaknesses and created action plans to deal with any challenges that arose. The second step included improving customer service, internal communication and a systematic introduction of comparative examination.
Dr Paul Bachmann, Senior Quality Manager thinks the award is well deserved, "We put a lot of time and commitment into the projects and the outcome is entirely positive for all our employees." His words were backed by Henri Lenn, President of GC Europe who commented, "Our philosophy is that quality is the core of any business process. This is the only way to build trust and achieve long-term success for everyone involved." GC Europe is now working towards the second of the three EFQM awards and aims to receive the 'Recognized for Excellence' award by 2008.
www.gceurope.com|~
Global oral health tops WHO agenda
For the first time since 1981, oral health was on the agenda at the World Health Organization's (WHO) Executive Board Meeting in Geneva. The WHO's Global Oral Health Programme prepared an extensive report on 'Oral health: action plan for promotion and integrated disease prevention'.
The President of the FDI World Dental Federation, Dr Michèle Aerden, addressed the WHO Board on this occasion and recognised the important strategic principles mentioned in the report. The FDI supports the integration of oral health into general health promotion and is keen to involve the dental profession as active and responsible partner in integrated disease prevention. "By reducing the risks common to many chronic diseases, such as smoking or high sugar consumption we do not only improve oral health, but also other chronic diseases such as diabetes or cardio-vascular diseases," said Dr Aerden in her statement.
The report of the WHO cited oral disease as a serious public health problem; linking periodontal disease and tooth loss to other chronic diseases and oral cancer to such lifestyle determinants as tobacco and alcohol consumption.
www.fdiworldental.org|~
New regulations for medical devices
Eucomed, representing approximately 4500 small medical technology manufacturers in Europe, has called on the European Parliament ENVI Committee to exclude any product whose principal mode of action is that of a medical device from the scope of the new Advanced Therapy Medicinal Products Regulation. In addition, the body has requested an appropriate transition period to adapt to the new legislation.
The fundamental distinction between medical devices and medicinal products is the mode of action. Medical devices are typically mechanical while medicinal products have a pharamcologic, immunologic or metabolic action.
Maurice Wagner, Director-General of Eucomed, made the following statement: "Eucomed welcomes the proposal for an Advanced Therapy Medicinal Products Regulation. The aim is to create a harmonized EU legal framework for marketing cell and gene therapies and human tissue engineered products. This is a great opportunity for European patients, who will benefit from improved access to a wide range of these highly innovative technologies. The proposed regulation is based on the medicinal products regulatory model. For Eucomed, however, certain types of human tissue engineered products should rather be regulated as a medical device."
Demineralized bone powder, which is used to repair small defects in bones, is a typical example of a medical device-like tissue engineered product (mechanical action). This type of product should not fall within the scope of the Advanced Therapy Medicinal Products Regulation.
This should also be the case for products combining a medical device such as a hip or dental implant, with an autologous human tissue or cell coating (patient's own tissue or cells added for biocompatibility and/or better osteo-integration), as long as an appropriate authorization mechanism is enforced for the tissue and cell components. Such 'combination' products will become increasingly widespread in the future.
The overall therapeutic tool is clearly a medical device (hip joint or dental implant) and should be regulated as such. Several other types of products falling under the scope of the Advanced Therapy Medicinal Products Regulation are marketed today under national regimes that do not require a medicinal products-style evaluation procedure.
Manufacturers of such products — mostly small companies and start-ups — will need to adapt to meet the new data requirements for marketing authorization. Eucomed estimates this could take up to 5 years. The text currently proposes a transition period of two years.
