CDU

PARIS — On one level at least, Europe is only an idea. It has a flag and an anthem, but no constitution nor a mandate to regulate health policies and practices. On the ground, it is a landscape of 27 independent nations, with as many as 270 autonomous local markets, each with different rules regulating medical devices, distinct reimbursement policies and unique distribution systems.

"Viva la difference!" was the shared theme coming out of conversations with several manufacturers of medical devices, presenting novel products at the 13th annual European Congress of General Practice here last month under the umbrella of the World Organization of Family Doctors (WONCA). Complexity such as this may serve to push considerable novelty as a means for differentiating your products in a heated competitive field.

Some examples in the cardiovascular sector:

• Microlife Europe (Widnau, Switzerland) introduced a blood pressure (BP) monitor that it hopes will change general practitioners' treatment of hypertension, a key risk factor for stroke. Wolfgang Hummel, Microlife VP for business development, said that currently physicians take a single reading of BP from patients during an office visit and then quickly prescribe a medication.

In line with a conference theme urging greater evidence for medical practice, the WatchBP unit from Microlife enables a patient to monitor BP four times each day for seven days, providing 28 readings. The physician version of Microlife Watch BP provides software to analyze the results. "A more complete set of data quite likely could change a physician's decision on which medication to prescribe resulting in a therapy more appropriate to a specific patient," Hummel said.

Microlife's blood pressure monitoring is integrated into Microsoft's (Redmond, Washington) newly launched consumer health platform, HealthVault.

Developed in cooperation with the European Society of Hypertension (ESH), the WatchBP line includes a double-cuff unit for measurement at the physician's office as well as the computer interface for analyzing and storing patient data, a portable model loaded with pre-set functions for an ambulatory setting, and the home model for patient self-measurement. After a week of regular measurements, patients return to the physician's office with the unit and the stored data for a consultation.

Hummel said the company is looking to add a feature for remote data transmission, likely using general packet radio service (GPRS) on Europe's global system for mobile (GSM) networks. This feature would be included for the final version to be released in Europe in early 2008. Bluetooth remote transmission of data is included in the ambulatory model so that a patient's blood pressure can be measured in the physician's office or in a public screening setting, but away from the doctor to avoid the so-called "white coat syndrome."

"We have many competitors for blood pressure monitors, obviously, but we are the only company working with ESH for measurements validated by international protocols," said Hummel. "Their endorsement comes from the fact that results from WatchBP are automated and reproducible, providing greater evidence for treatment.

Microlife has submitted an FDA 510(k) application, and Hummel said the company anticipates U.S. product launch in 2008.

• HemoCue (Angelhom, Sweden) presented its point-of-care white blood cell (WBC) test, drawing a crowd of doctors from Greece to the UK for the demonstration of the desk-top unit.

Winning headlines after its introduction at the 2006 annual meeting of the American Association for Clinical Chemistry the HemoCue WBC to date has only been distributed in the home market of Sweden, according to Global Product Manager Annika Eriksson.

A droplet of the patient's blood is drawn with a micro-cuvette and then mixed with an onboard staining agent. The cuvette is placed into the HemoCue WBC unit and after three minutes the built-in testing unit displays results on a screen.

From an increased total WBC, a physician can infer a bacterial infection, and the test thus provides immediate guidance for whether or not to prescribe antibiotics. Over-prescription of antibiotics has become a concern in many European countries facing elevated drug reimbursement expenses and has created a public health issue as bacteria develop antibiotic resistance.

"We are ready for a good acceptance in the other Nordic countries but have not completed plans for the rest of Europe," Eriksson said. HemoCue WBC is priced at e400 ($564).

Introduction to the U.S. is planned for some time in 2008, contingent on receiving a Clinical Laboratory Improvement Act (CLIA) waiver so that non-clinical staff in a general practice office are authorized to perform the test.

• Orion Diagnostica (Espoo, Finland) presented its QuickRead C-reactive protein (CRP) test, also a desk-top diagnostic unit that provides results in a few minutes from a finger-stick blood sample to aid in a decision for prescribing antibiotics.

Present in very low concentrations in the blood of a healthy patient the CRP level can increase slightly with viral infections but shows markedly high elevation for bacterial infections where an antibiotic could prove effective.

"We are introducing a new thinking for doctors in many European countries," said a company sales director who aked not to be named. "This is not blood pressure measurement and physicians are not used to performing biochemical tests."