CD&D European Editor and Staff Reports

Beginning June 1, HbA1c (long-term blood glucose levels) in all people with diabetes will be measured in millimoles per mol as well as by percentage, the UK Department of Health said.

The UK is responding to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) call for all countries to adopt the same measurement to make it easier to compare HbA1c results among laboratories throughout the UK and worldwide.

Both the old and the new measurements will be given for the first two years of the change, until May 31, 2011, when people with diabetes will receive their HbA1c measurement only in millimoles per mol.

Dr. Rowan Hillson, national clinical director for diabetes, said, "It is really important that people with diabetes keep their blood glucose levels under good control. Controlling the glucose in a way that is safe and appropriate for each person reduces the risk of diabetic tissue damage. People with diabetes need HbA1c blood tests to check their glucose is under good control. This . . . change in the way that HbA1c is reported is being introduced in a way that allows plenty of time for us all to get used to it."

Simon O'Neill, director of care and policy at Diabetes UK, said, "Diabetes UK welcomes this change to the way HbA1c results are reported and we believe that this will have the additional benefit of making comparing results from international laboratories and research trials easier, as the new system will be adopted worldwide."

He added, "For a period of two years, people with diabetes will get their results in both percentage and millimoles per mol, which will help them get used to the new system. In addition, Diabetes UK has designed a convenient online HbA1c converter tool for people with diabetes to help them through the transition."

Italian stent maker defends patent

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).

Australia approves SyntheMed's Repel-CV

SyntheMed (Iselin, New Jersey), a biomaterials company that is developing anti-adhesion products, reported that Repel-CV, the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received approval from the Australian Therapeutic Goods Administration for use in all patients who undergo open-heart surgery.

Repel-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the extent and severity of adhesions, or scar tissue, that form between the surface of the heart and opposing tissue surfaces following the surgical procedure. It is designed to perform the therapeutic task and then degrade so that it is cleared from the body.

Tag Medical, a distributor of cardiac surgery products, will market repel-CV throughout Australia.

Repel-CV is FDA-approved for use in pediatric cardiac surgery patients and is marketed in the U.S. through a direct sales force. It also has CE-mark approval for use in all cardiac surgery patients and is marketed in the European Union and certain other international countries through a network of independent distributors.

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 that 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."

NHS projects awarded over £1 million

Ten healthcare scientists from across England have been awarded research fellowships worth a total in excess of £1million for projects that will lead to improvements in patient care, Chief Scientific Officer Sue Hill reported.

The awards were the results of the first round of the new CSO Research Fellowship competition launched last September to support the development of research capacity in healthcare science in the NHS. The program is funded by the UK Department of Health and managed by the National Institute of Health Research.

The projects include a range of healthcare science activities such as developing techniques to diagnose health conditions and improving patient care for cancer, diabetes and cardiovascular and respiratory disease. Along with supporting individual research programs, the funding will support the postgraduate training needs of each research fellow.

The CSO Research Fellowship Competition will run for another two years and provide a total of £4 million in funding.

Cook graft approved in Canada

In what it said is a move reflecting the rapid acceptance of its advanced endograft for thoracic aortic aneurysm worldwide, Cook Medical (Bloomington, Indiana) reported receiving approval to market the Zenith TX2 TAA Endovascular Graft in Canada.

Globally, the Zenith TX2 Endovascular Graft is now available in more than 60 markets, including the U.S., Canada, UK, European Union, Australia and others.

"Physicians around the world have made Cook's Zenith AAA Endograft the world's best-selling device of its kind, and we're now seeing similar momentum in the growing market for endovascular treatment of thoracic aortic aneurysms," said Phil Nowell, global leader of Cook's aortic intervention business unit.

One of Canada's leading endovascular specialists, Cherrie Abraham, MD, of the department of vascular surgery at Jewish General Hospital of McGill University (Montreal), said, "This approval is a recognition that this is an excellent graft that is here to stay. The biggest advantage with TX2 is the control offered by the trifold proximal end. With TX2, we now have the ability to deploy a graft without the wind-sock effect that is seen with other commercially approved thoracic stent grafts. I also like that even after unsheathing the graft, you still have the ability to advance it proximally, again because of the constrained top end."

Cook said U.S. sales of the TX2 Endograft have increased every month since it received FDA clearance in June 2008. During that period, roughly 1,000 physicians at nearly 400 hospitals in the U.S. have requested and received training in the appropriate use of the TX2, making them eligible to bring the advanced benefits of this device to numerous patients suffering thoracic aortic aneurysms.

"With sales of the Zenith TX2 Endograft accelerating each month, and the recent CE-mark approval for our next-generation TX2 Endograft with Pro-Form, we believe Cook is on track to achieve market leadership in thoracic aneurysms, as well," Nowell said

The Zenith TX2 Endograft is indicated in Canada for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.

New software from TomTec

TomTec (Munich, Germany) has launched its 2D Cardiac Performance Analysis software as part of its CardioArena multimodality imaging solution at the American Society of Echocardiography congress in Washington.

2D Cardiac Performance Analysis allows cardiologists to study the behavior of the heart muscle quickly and easily. Quantitative assessment of displacement, velocity and strain in individual muscle segments is available. The diagnosis of pathologies like hypertrophic cardiomyopathy or dyssynchronous ventricles improves with this software and the decision for a cardiac resynchronization therapy is then more confident.

2D Cardiac Performance Analysis is a speckle tracking based analysis tool which can analyze 2-D data from various ultrasound machines. The user can utilize the data of different ultrasound systems and is not limited to specific vendors.

Already-acquired studies can also be analyzed with TomTec's 2D Cardiac Performance Analysis.

China MED draws 26,000-plus

The recent staging of China MED 2009, the 21st International Medical Instruments and Equipment Exhibition held in Beijing, featured 505 exhibitors from 22 countries showcasing their products over 322,900 square feet of exhibit space to 26,408 attendees.

Sponsor Messe Duesseldorf, which puts on the world's largest medical trade exposition, MEDICA, said CHINA MED 2009 featured not only IT technology, medical software, surgical instruments, medical diagnostics and imaging equipment, but also special exhibits for medical consumables, orthopedics, dental and rehabilitation equipment.

Messe Duesseldorf said the number of visitors confirmed the rapid growth and development of the Chinese medical care industry. About 30% of the visitors were from medical organization and R&D institutes, while 60% were wholesalers and distributors.

According to the People's Republic of China customs statistics, the export of medical devices, equipment and products from January to November 2008 was worth $3.2 billion, an increase of 31.4% compared to the same period of 2007.

Messe Dusseldorf said it is estimated that the peak for the Chinese medical industry development will be between 2008 and 2010.

It said CHINAMED 2009 exhibitors were pleased with the visitor quality and quantity. "It is encouraging that we have found both clients and supplier in this trade fair. The platform provided by CHINA MED enhances the interaction among the participants effectively. The large visitor participation makes me confident about China's future," said Thomas Gutridge of Blu-med. Zhang Ning of Ningbo Xingaoyi agreed, saying, "The percentage of trade visitors seems higher than ever. This is our first time we participated as an exhibitor and the results are good."

Jim Litter, VP of service at Vital Image, said, "Sometimes we were too busy to have lunch because there were always visitors interested in our products."

The exhibits at CHINA MED 2009 were complemented by more than 50 symposiums on topics such as medical imaging equipment, logistics and large equipment quality assessment as well as seminars about orthopedic trauma, tumor imaging diagnosis and clinical laboratory science.

The next staging of CHINA MED is scheduled for March 2010 in Beijing.