A Medical Device Daily

Kensey Nash (Exton, Pennsylvania) said it has received CE-mark approval for the third generation of its embolic protection technology, known as the TriActiv ProGuard System. It said it plans to launch the system in Europe for use in saphenous vein graft procedures by the end of 1Q06.

The TriActiv ProGuard System is designed to prevent material or debris dislodged during stent procedures from embolizing downstream and causing adverse coronary events such as a heart attack. The system includes three integrated features – an embolic protection balloon, and a combined active flush and extraction system to remove problematic debris from the target vessel.

The company said the TriActiv ProGuard System incorporates several important design enhancements to the TriActiv System platform, including Local Flush and eXtraction (LFX) technology, which allows the system to better address branched anatomy, along with a new, smaller 6F-compatible size, which it said is generally preferred by physicians, particularly in Europe.

“This is a very important product introduction for the European market,“ said Joe Kaufmann, president and CEO. “The ProGuard design allows for greater utility of the system through its ability to be used in branched vessel situations and its highly desirable 6F compatibility. The flexibility of this product to be used in branched anatomy is a fundamental enhancement to the TriActiv product line.“

He said Kensey Nash now will “actively pursue“ study of the platform's utility in native coronary and leg and renal peripheral anatomies, as a complement to its ongoing study of the ProGuard system in the carotid anatomy.

“We are now significantly closer to our objective of offering our physician customers in Europe a complete line of first-class embolic protection products,“ Kaufmann said.

The company's TriActiv System is cleared for sale in the U.S. The second-generation TriActiv FX System is approved for sale in the European Union. Regulatory clearance for the TriActiv FX is pending in the U.S.

Dutch study finds many undiagnosed MIs

Dutch researchers who analyzed more than 4,000 men and women over age 55 to see how many heart attacks went undiagnosed at the time they occurred, found that the figure was more than four in 10.

The results come from an analysis of a large proportion of the men and women involved in the Rotterdam Study, a prospective population study investigating chronic disabling diseases. A total of 5,148 participants with no evidence of prevalent myocardial infarction (MI) were enrolled from 1990 to 1993.

Their report was published in the Feb. 14 edition of European Heart Journal, the journal of the European Society of Cardiology (Sophia Antipolis, France). The authors, who are from the department of epidemiology and biostatistics at Erasmus Medical Center (Rotterdam, the Netherlands), say their findings suggest that the role of ECGs in existing cardiovascular prevention programs should be evaluated.

The patients assessed by the researchers underwent a baseline ECG and examination. Data from clinically recognized MIs (i.e., heart attacks that were formally diagnosed) over the years that followed were analyzed. The 4,187 of the total who had at least one repeat ECG during two rounds of follow-up assessment between 1993-96 and 1997-99, were analyzed for clinically unrecognized MI.

Senior author Dr. Jacqueline Witteman, associate professor of epidemiology, said, “Over our median follow-up time of more than six years, we found an incidence rate of nine heart attacks per 1,000 person-years. There were around 12 heart attacks per 1,000 person-years in men (8.4 recognized and 4.2 unrecognized) and around seven per 1,000 person-years in women (3.1 recognized and 3.6 unrecognized). Additionally, in men as well as in women, there was one sudden death per 1,000 person-years.“

Overall, she said, 43% of the total heart attacks had been clinically unrecognized – one-third of the male heart attacks and more than a half of the female heart attacks.

Witteman said that in each of the age bands between 55 and 80, men had a higher incidence of recognized MIs than women and a similar incidence of unrecognized MIs. This provided the evidence that heart attacks are less often recognized in women, she said, irrespective of characteristics that have previously been associated with MI.

Co-author Dr. Eric Boersma, associate professor of clinical cardiovascular epidemiology, said that although the study was conducted in the Netherlands, the results were likely to be equally applicable to any other developed country.

He said that in most developed countries, cardiovascular prevention programs are installed, which aim to identify high-risk individuals on the basis of classical risk factors, including smoking and obesity, and co-conditions, such as diabetes mellitus. “Our findings indicate that these programs might be enriched with an ECG,“ Boersma said.

Orthogen to broaden Orthokine efforts

Citing the successful completion of clinical studies, Orthogen (Dusseldorf, Germany) said it intends to build up Europe-wide distribution of Orthokine, a medical device for the production of autologous conditioned serum containing anti-inflammatory cytokine antagonists and growth factors.

Two universities performed randomized, double-blind studies demonstrating Orthokine's high efficacy and safety in the therapy of osteoarthritis of the knee and low back pain. “Due to its beneficial side-effect profile, Orthokine therapy represents an efficient alternative to steroids, hyaluronic acids and analgesics [such as] COX-2 inhibitors,“ said Dr. Peter Wehling, CEO of Orthogen.

After the build up of sales in Germany over the last year, the molecular orthopedics specialist company now intends to extend its activities to the broader European market. It also has filed application with the FDA for sales in the U.S.

Orthogen also is working on a stem cell technology for the regeneration of cartilage from non-embryonic stem cells. It said initial clinical results on humans have demonstrated feasibility of the method, which is intended to replace what the company terms “time-consuming autologous chondrocyte implantation.“

Also under development is an immune-modulatory therapeutic approach for the treatment of rheumatoid arth-ritis with so-called exosomes, which the company referred to as “highly efficient anti-inflammatory nano-particles.“ It said this method could become a highly efficient and safe alternative to cytokine antagonists produced with recombinant techniques.

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