A Medical Device Daily
Medtronic (Minneapolis) recently reported the European introduction of Reveal XT, which it described as "the first insertable cardiac monitor that offers long-term and continuous monitoring of atrial fibrillation" [AF].
Noting that all other current monitoring tools are either for a limited period or on an intermittent basis, Medtronic said long-term, continuous monitoring "means that a clinician no longer needs to rely only on incomplete data to evaluate how AF may be progressing or treatment effectiveness."
The Reveal XT Insertable Cardiac Monitor monitors AF patients 24 hours a day, every day for up to three years. Medtronic said that until now, physicians had no means of gathering detailed data, over an extended period, on the progression of AF and the effect of treatment. It said Reveal XT data "may help physicians to evaluate stroke risk and determine appropriate treatment and therapy options for their patients."
The device recently received CE-mark approval, and the first implant of Reveal XT took place at Asklepios Klinik St. Georg (Hamburg, Germany) by Karl-Heinz Kuck, MD.
"Atrial fibrillation is the most frequent cardiac arrhythmia. It is often accompanied by symptoms that are very unpleasant for the patient," said Kuck. "Moreover, atrial fibrillation is linked with increased mortality and an increase in the incidence of stroke, by a factor of two- to seven-fold. However, with the new Reveal XT, atrial fibrillation can now be scrutinized over a period of three years with a subcutaneous monitor. This gives us totally new possibilities for monitoring and adjusting the treatment."
Direct sales force for CryoLife in Germany
CryoLife (Kennesaw, Georgia) said it has established a direct sales force through its European subsidiary, CryoLife Europa (Guildford, UK) to service the German medical market in that country.
The German sales team, which is based in the life sciences cluster of Baden-Wuerttemberg, is CryoLife's second direct sales force outside of the U.S. The company also sells direct in the UK.
"We are excited about the potential for growth in the German market," said Steven Anderson, president/CEO of CryoLife. "While we work with distributors throughout Europe, CryoLife Europa decided to go direct in Germany to capitalize on the strong interest in our products there. We believe that by having our own sales channel in Germany, we can focus our selling efforts, strengthen our market presence and more readily launch new products."
The German sales force will include three sales representatives and a sales manager. The first two sales representatives will cover southern Germany, mainly Bavaria and Baden-Wuerttemberg, and northeast Germany, which includes Berlin, Hamburg and Leipzig. Plans call for the addition of a third sales representative to cover the western German territory by the end of this year.
The sales team will initially concentrate on sales of CryoLife's BioGlue surgical adhesive and the distribution of allograft tissues.
Prior to the creation of a direct sales operation in Germany, CryoLife Europa distributed the company's products in Germany through Krauth Medical .
CryoLife Europa, which was established in 1999, directs the distribution of CryoLife products and tissues throughout Europe, the Middle East and Africa.
CryoLife's BioGlue surgical adhesive is CE-marked and approved in Canada and Australia for use in soft-tissue repair. The company also distributes the CryoLife-O'Brien stentless porcine heart valve and the SG Model 100 vascular graft, which are CE-marked for distribution within the European Community.
Study cites role of MPO in cardiac risk
A study published in the July 10 issue of the Journal of the American College of Cardiology (JACC) reports that European researchers have uncovered a new clue to the mystery of how a seemingly healthy person can actually be at high risk for heart disease or a heart attack.
The culprit is myeloperoxidase (MPO), a protein secreted by white blood cells that signals inflammation and also releases a bleach-like substance that damages the cardiovascular system.
Although MPO is intended to kill harmful bacteria, it may instead inflame the body's arteries and cripple protective substances in the blood, according to the study. Long before conventional risk factors set off alarms, elevated MPO levels signal that harmful plaque has been building up.
"We were surprised to find that many years before a cardiovascular event actually occurs, MPO is increased," said Matthijs Boekholdt, MD, PhD, a resident in cardiology at Academic Medical Center (Amsterdam, the Netherlands). "As we learn more about these processes, we hope to be able to identify 'vulnerable blood' as a reliable tool for detecting vulnerable patients."
Boekholdt and colleagues recruited healthy people living in Norfolk, UK, between 1993 and 1997, as part of a larger community-based research program known as the European Prospective Investigation Into Cancer and Nutrition (EPIC). They took baseline blood samples from each participant and froze the samples for future analysis.
After an average of eight years, 1,138 EPIC-Norfolk participants had been admitted to the hospital or died from the effects of coronary artery disease (CAD), including heart attack. The average blood levels of MPO were "significantly higher" in those who developed heart disease than in those who remained healthy.
When MPO levels were divided into four groups, patients in the highest fourth were 1.49 times as likely as those in the lowest fourth to develop CAD or have a heart attack.
When traditional risk factors blood pressure, LDL and HDL cholesterol levels, body mass index, smoking and diabetes were taken into account, an MPO level in the highest fourth increased the risk of heart disease by 1.36 times. Elevated MPO levels signaled increased risk even in those with acceptable levels of LDL cholesterol, HDL cholesterol or C-reactive protein, a well-known marker of inflammation.
"[This] is the first large-scale study to examine the relationship of MPO to cardiovascular risk in apparently healthy individuals," Boekholdt said. "MPO levels help to identify individuals at increased risk for CAD when traditional risk screening fails."
One of the study's authors, Stanley Hazen, MD, PhD, is named as a co-inventor on pending patents filed by the Cleveland Clinic Foundation (Cleveland, Ohio) relating to the use of MPO as a biomarker for cardiovascular disease.