Genius coronary stents and Amadeus PTCA balloon catheters from EuroCor (Bonn, Germany) were first CE-marked in April 1999 and already have had a significant impact on the highly competitive European stent sector, with a share of more than 10% in several national markets, according to Michael Orlowski, company president. EuroCor is projecting a 5% to 10% world market share by 2003 and is actively seeking a marketing partner in the U.S. as an essential factor in this project.
"The scientific development of our products is based on an analysis of product technologies available in the marketplace. The clinical benefit of our Genius coronary stenting system is unmatched by any other competitive product," Orlowski said. He noted, "the immediate and clinical long-term results after 6 months to 12 months of Genius implantation confirm a restenosis rate of only 11% (Israel Heart Society Study results)."
The company is ready to launch its RadiMAX peripheral stent line, followed by balloon-expandable renal, iliac and femoral stents and a line of self-expandable nitinol stent designs. Orlowski intends to enter the growing neuroradiology sector early in 2001 with a line of microcatheters and embolic agents for minimally invasive techniques.
EuroCor's ambitious marketing and product development plans appear to be supported by equally positive study results from Professor Thomas Ischinger at the Munich University Clinic (Munich, Germany), Professor Nicolaus Reifort at the Frankfurt Heart Center (Frankfurt, Germany) and Professor Glogar at the Vienna University Clinic (Vienna, Austria). The six-month follow-up results in the Munich study on 50 implantations of Genius coronary stents showed only 13% restenosis and 8.5% target vessel revascularization (TVR), with comparable results at six months from the Vienna study on 200 patients in four hospitals.
NHS acts to reduce UK cardiac fatalities
"The burden of heart disease is higher and has fallen less in the UK than in many other countries," said the British government in its recently published National Health Service (NHS) plan. By 2003-2004, an extra $345 million will be invested annually in addressing heart disease, which kills 110,000 people in England alone each year. The NHS has set a target of reducing cardiac fatalities by 20,000 annually over the next five years.
A network of rapid-access chest pain clinics is to be set up to provide 200,000 patients each year with a diagnosis of cardiac symptoms within two weeks. Numbers of coronary artery bypass grafts (CABG) and percutaneous transluminal coronary angioplasties (PTCA) are to be increased to 750 per million population (about 36,500 procedures each), compared with current levels of 450 and 375 per million, respectively.
To meet its efforts to significantly reduce diagnosis and treatment times, the government also has announced a substantial facilities development program which will provide the NHS with more than 100 new hospitals by 2010, as well as 500 new "one -stop" primary care centers offering a range of services under one roof. The government also plans to acquire 3,000 automatic external defibrillators and install them in public places such as airports, railway stations, sports stadiums, etc., as well as to train personnel in their use.
The Department of Health has set up 10 fast-track programs as part of an initiative to provide integrated heart disease care throughout the NHS in England. The aim of the programs is to improve emergency response, treatment and follow-up care for heart attack patients, as well as to integrate diagnosis and follow-up treatments. The government believes that the fast-track program will help the NHS reach its target of increasing the number of heart operations by 3,000 over the next two years and by an additional 3,000 the following year (these totals include CABG and PTCA procedures).
Mercury-based devices to be phased out in UK
The UK's Medical Devices Agency (MDA; London) has recommended that greater consideration be given to using mercury-free devices for noninvasive blood pressure monitoring. Subject to clinical performance limitations, and taking into account the toxicity risks of mercury, the MDA considers that the increasing reliability of non-mercury devices justifies their greater use. The MDA has noted the increasing use of the automatic cycling noninvasive blood pressure (NIBP) monitor and its low-cost automated versions as acceptable alternatives. "Although at present no ban has been imposed on the use of medical devices containing mercury in the UK, it is recommended that consideration is given to the selection of mercury-free products when the opportunity arises," the MDA said.
Factor VIII levels a thrombosis indicator
High plasma Factor VIII levels in patients who have experienced a first episode of venous thrombosis could be an indicator of increased risk of recurrent venous thromboembolism. Paul Kyrle and his group at Vienna University Hospital (Vienna, Austria) measured Factor VIII levels in 360 patients suffering from a first episode of venous thrombosis.
Kyrle reported that 38 (10.5%) experienced further thrombotic episodes and that those patients all showed higher mean Factor VIII levels than the remaining patients without recurrence. Among patients whose Factor VIII levels were above the 90th percentile of values in the study group, the risk of recurrence of thrombosis within two years was 37%. In patients with lower levels, the risk was 5%.
Hormone assay in assessing heart failure
Assays of serum concentrations of brain natriuretic peptide (BNP) as a guide in the treatment of heart failure have been proposed by Richard Hobbs, professor of primary care and general practice at the University of Birmingham (Birmingham, England). Previously, BNP measurements have been proposed as an emergency room tool to assess congestive heart failure.
A problem experienced by many primary physicians is the diagnosis of patients with suspected heart failure and preserved left ventricular function, especially since in Europe access by primary care physicians to echocardiography (ECG) facilities often is limited. In this situation, Hobbs suggests that BNP assays have the potential for triaging to decide which patients should be sent for ECG.
Since the BNP assay only has a positive predictive value of around 70%, its use as a screening tool in general healthy populations would seem inappropriate.
Visible heart beats
Researchers at the Fraunhofer Institute for Computer Graphics Research (IGD; Darmstadt, Germany) have developed a software system capable of generating a 3-D dynamic model of the human heart. This makes it possible to observe the ventricles of the heart and the movement of their walls, thus acquiring a full picture of the patient's condition.
Until now, diagnosis by cardiologists has involved the study of individual cross-sections. Now, with the help of the Cardiac Station system, the software converts 2-D images to a dynamic 3-D model. The ventricle walls are displayed on the computer screen in various colors, depending on the rate at which the heart is beating.
The system facilitates diagnosis, as in the case of a heart attack where parts of the cardiac muscle are no longer supplied with blood and whose movements are therefore restricted. These will show clearly on the screen in a different color from healthy areas. The software has been undergoing trials at a number of cardiology clinics in Germany and South Korea since June.
Sulzer heart valve sales up
First-half sales at Sulzer Medica (Winterthur, Switzerland) increased 7% to $403 million, with adjusted operating income up 13% to $59 million. Mechanical heart valve sales increased in all sales regions, while tissue valve sales grew particularly strongly in Europe, contributing to a 12% first-half growth to $72 million in the cardiovascular division.