A Medical Device Daily

Carbostent & Implantable Devices (CID; Saluggia, Italy), a former Sorin Group business unit dedicated to developing minimally invasive implantable devices, reported that it has successfully defended its European Patent 1277449 against an opposition filed by Conor Medsystems (Menlo Park, California), a Johnson & Johnson (New Brunswick, New Jersey) subsidiary, on proprietary drug-eluting stent technology.

Both companies, CID and Conor, utilize stent platforms for coronary arteries that release drug from reservoirs located on the stent surface.

After oral proceedings in early March, the opposition division of the EPO Office in Munich held that patent claims, presented to that office, were "fully valid and maintained."

CID said it was the first company in the world to market a polymer-free, drug-eluting stent. "This know-how, developed totally in-house, offers physicians the unique advantages brought by the combination of Carbofilm, [our] highly biocompatible coating proven to significantly reduce the risk of thrombotic events, and a proprietary drug release system based on the use of reservoirs on the stent's outer surface to ensure a targeted drug release towards the vessel wall," said CEO Franco Vallana.

He added, "This result, obtained after highly contested opposition proceedings, confirms the value of CID's intellectual property."

CID is fully entitled to exploit all the unique features of its technology, said Vallana "CID's drug-release platform avoids the use of polymer to carry the drug, thus eliminating the shortcomings often associated with polymers; moreover the reservoirs placed on the stent's outer surface ensure targeted drug release towards the vessel wall."

"These key elements allow for a limited period of dual antiplatelet therapy duration, thus reducing the life-threatening bleeding risks a forced prolonged dual antiplatelet therapy may induce in some patients," said J. Koolen, MD, of Catharina Hospital (Eindhoven, the Netherlands).

IVD-CE mark for MALDI Biotyper

At the 19th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Helskinki, Finland, Bruker Daltonics (Billerica, Massachusetts) reported that its MALDI Biotyper workflow for microbial identification in clinical microbiology has obtained an IVD-CE mark with a Declaration of Conformity in accordance with European Union In Vitro Diagnostic Directive 98/79/EC.

At ECCMID 2008, Bruker Daltonik GmbH (Bremen, Germany) had reported the adaptation of its quality management system according to the ISO 13485 standard for the design, development, manufacturing, sales, distribution, installation and service of instruments and systems for in vitro diagnostic use.

In recent months, Bruker has organized and conducted extensive successful performance evaluation studies on the MALDI Biotyper workflow at several centers for clinical microbiology. One clinical studies partner was Laboratory Limbach (Heidelberg, Germany), which is the headquarters of a network of more than 25 associated private clinical laboratories in Germany.

Another clinical studies partner was the Max von Pettenkofer-Institute (Munich, Germany).

During these clinical studies, the overall identification accuracies for several microbial groups have been confirmed. Additionally, a stress test demonstrated the broad applicability of the MALDI Biotyper approach over a wide range of different microorganisms. The stress test also demonstrated that the MALDI Biotyper workflow can be applied on all linear-only Bruker MALDI-TOF mass spectrometers under IVD-CE.

Outside of the European Union, the MALDI Biotyper workflow is presently for research use only.

Dr. Ulrich Eigner, head of molecular studies at Laboratory Limbach, said, "The MALDI Biotyper is a promising new molecular approach for microbial identification. The speed of identification is impressive, thus significantly decreasing the turnaround times in our laboratory."

Smoking's cardio risks cited

Non-smokers live longer and have less cardiovascular disease than those who smoke, according to a 30-year follow-up study of 54,000 men and women in Norway. Smoking, say the investigators, is "strongly" related to cardiovascular morbidity and mortality from various causes.

The results, presented recently in Stockholm, Sweden, during EuroPrevent 2009, reflect what many other studies have indicated, but, says investigator Professor Haakon Meyer from the University of Oslo and the Norwegian Institute of Public Health, these results provide a picture of the long-term, absolute "real life" risk.

His conclusions are based on a far-reaching follow-up study which began in 1974 with an invitation to every middle-aged man and woman (ages, 35-49) living in three counties of Norway to take part in a basic cardiovascular screening examination. The invitation had a huge response, with 91% attending for the baseline screen.

Over the next three decades, deaths were recorded by linkage to the Norwegian population registry and, between 2006 and 2008, those surviving responded to a follow-up questionnaire. This allowed division of the participants according to their smoking status – never-smokers, ex-smokers, current smokers of 1 to 9 cigarettes a day, 10 to 19 cigarettes a day and more than 20 cigarettes a day (the last group referred to as "heavy smokers").

Study results showed that, from the original 54,075 participants, 13,103 had died by the time of follow-up. Of these, 45% of the heavy-smoking men had died during the 30 years, compared to just 18% of the never-smokers. Similarly, 33% of the heavy-smoking women had died, but only 13% of the never-smokers.

"These results show what a tremendous impact smoking has on mortality," says Meyer. "We are talking about very high numbers of people."