A CDU

Organizations representing patients, healthcare workers, academics, health experts and the medical technology industry have reported the creation of a new alliance, Health First Europe (Brussels, Belgium). Health First Europe said it would launch an awareness campaign this year to "encourage reflection and dialogue on the future of healthcare in Europe at a time of demographic and technological revolution."

It said it plans to host a number of high-profile events this year, such as a "medical devices of the future" exhibition at the European Parliament in Brussels. Efforts also will be focused on a number of international awareness days, such as World Parkinson's Day, through partnerships with related organizations.

The primary aim of the new alliance, according to its organizers, is "to ensure that equitable access to modern, innovative and reliable medical technology and healthcare is regarded as a vital investment in the future of Europe." Health First Europe said it is pushing for "a truly patient-centered healthcare where every European citizen is able to benefit from the best medical treatments available."

Alliance members added that they believe health should be seen as "a productive economic factor in terms of employment, innovation and economic growth." Barry Wilson, board chairman of Eucomed (Brussels, Belgium), the European medical technology trade association, said, "New life-saving breakthrough therapies in medical technology are delayed in their availability to patients across Europe due to inadequate funding and reimbursement." He said the fundamental issues remain the low percentage of gross domestic product spent on healthcare and the way that healthcare resources are allocated. "In defining their economic priorities, the EU member states should focus more on the needs of their aging populations," Wilson said. "European citizens want and need better access to life-saving and life-enhancing medical technology."

John Bowis, a member of the European Parliament and a former UK Minister for Health, said the establishment of Health First Europe "comes at a time when patients, the medical profession and industry, as well as relevant authorities, must look at how Europe will maintain the healthcare provisions that citizens have come to expect." For example, he said, "the greying of the European population and the rapid progression of medical innovation pose a number of important challenges and opportunities today. In order to meet these challenges, a rethink[ing] of European healthcare systems is required."

Saying that patient and clinical access to "modern, innovative and reliable medical technology and healthcare" should be regarded as a vital investment in the future of Europe, Albert van der Zeijden, chairman of the International Alliance of Patients' Organizations (London), added: "We must ensure that access to, and availability of, the most effective treatments and medical devices are made available to all patients."

Felix Unger, MD, president of the European Institute of Medicine (Vienna, Austria), said healthcare "is still all too often considered as a drain on public finances, as a 'bottomless pit.' Yet healthcare is a key economic factor in terms of employment, innovation and economic growth." He said a healthy society "is an indispensable prerequisite of a flourishing and wealthy society."

ENDEAVOR II stent trial expanded

The first implant in an expansion of Medtronic's (Minneapolis, Minnesota) ENDEAVOR II clinical trial in Europe took place last month at the Hospital of the Merciful Brother (Trier, Germany). The expanded trial arm is directed toward increasing patient exposure to Medtronic's investigational Endeavor drug-eluting coronary stent, with a total of 300 patients to be enrolled at about 15 international sites. Data from the expanded trial will be used to support product approvals globally, the company said.

The Endeavor drug-eluting stent system combines Medtronic's Driver coronary stent, the drug ABT-578 and a PC polymer into a system designed to reduce restenosis. The ABT-578 compound is licensed to Medtronic by Abbott Laboratories (Abbott Park, Illinois). Medtronic also licenses Abbott's proprietary phosphorylcholine coating technology (PC Technology), designed to serve as the delivery matrix, which controls the elution of ABT-578 directly into the arterial wall.

The trial will include the standard endpoints of major adverse cardiac events (MACE) at 30 days, target lesion revascularization, target vessel revascularization and target vessel failure at nine months, with angiographic and intravascular ultrasound follow-up at eight months. The initial phase of the ENDEAVOR II trial, which included 1,200 patients, completed enrollment in January.

Karl Hauptmann, MD, who performed the first implant in the expanded trial, said Endeavor is "the most deliverable drug-eluting stent I have ever used." Noting that his hospital was an investigational site for the first phase of ENDEAVOR II, he said, "we have been extremely pleased with the performance of the Endeavor stent and are excited to be in the extended arm of the trial."