CDU Contributing Editor

DUSSELDORF, Germany – Disease management in Europe, as in other geographic segments of the medical device market, is increasingly focusing on technologies for use in a wider array of sites, including sites outside of the traditional hospital setting. Interest is growing in non-invasive monitoring technologies as well as in technologies for use in the home, and use of treatment modalities that can be employed by patients to manage their own disease is also expanding in the region. At the Medica 2001 exhibition, held here in late November, a variety of new minimally invasive and non-invasive monitoring technologies were demonstrated, along with new entrants in the market for patient-managed therapy such as portable insulin pumps. Advances also are emerging in information technology for patient monitoring in alternate sites, to improve the efficiency of patient management and, ultimately, patient outcomes. Furthermore, a new industry consortium is now working to develop connectivity standards for the European market that should give hospitals greater flexibility in equipment choice for critical care monitoring, and also provide standards for evolving home monitoring technologies.

Developments in critical care monitoring

Connectivity of devices used in point-of-care (POC) settings has been a major focus for manufacturers of in vitro diagnostic systems for the past few years, and the Connectivity Industry Consortium (CIC) has succeeded in developing industry-wide connectivity standards in that area. Now, an effort is under way to develop a global connectivity standard for vital signs monitoring devices that not only will be compatible with the CIC standard but also will address higher-level interface issues with clinical information systems, and that will have a goal of allowing patient monitoring systems to be linked via a plug-and-play concept. The VITAL project to develop the new interface standard is being managed by the Technical Committee for Health Information, CEN TC 251, of the European Committee for Standardization. The chairman of the program, Dr. Gunnar Klein, is based at Swedish Healthcare Standards Institute (Stockholm, Sweden). Manufacturers participating in the project include Baxter Healthcare (Deerfield, Illinois), Viasys Critical Care (Yorba Linda, California), Philips Medical Systems (Best, the Netherlands) and GE Medical Systems (Waukesha, Wisconsin). A pilot demonstration program is under way, linking Baxter infusion pumps, a Viasys ventilator, a patient monitor from GE and a workstation from Philips. Another demonstration has linked a ventilator from Siemens Medical Solutions (Erlangen, Germany), an Omicron Alter vital signs monitor from RGB Medical Devices (Madrid, Spain) and an infusion pump from B. Braun (Melsungen, Germany). Trends in Technology (Madrid, Spain), a satellite company of RGB Medical, provides services to manufacturers to adapt their products to the new VITAL standard. A key feature of the VITAL standard is the ability to accommodate existing devices either via an interface box that can connect to the VITAL standard, or by using an intelligent cable that identifies the device for execution of conversion software inside the VITAL hub. The VITAL system runs on a web server combined with a database server, and uses a uniform tree structure for all types of linked systems. The initial demonstrated applications for the VITAL technology are focused on anesthesia and critical care monitoring, although applications in alternate site monitoring, including home monitoring based on the VITAL Home network model, also are being developed.

HIG-Coachit (Kassel, Germany) exhibited the ClinicPalm, a new hand-held hospital bedside information system, at Medica. The ClinicPalm is based on the Palm computer platform and allows physicians to call up patient lists and individual patient data for each patient on a ward. Available data includes records of medications given, medication dosage, timing of delivery and planned dosage schedule, plus laboratory results and charts of the data. A central station placed in each ward allows data to be downloaded to each device, and also is used to upload data collected by the ClinicPalm to the central station. The central station is connected to the hospital's clinical information system via an HL-7 link. So far, the ClinicPalm system has been installed in one hospital, Klinikum Kassel (Kassel, Germany), an 1,100-bed institution with 52 wards. Cost is about 25,000 Euro per ward.

New developments in critical care monitoring technology also were a highlight of the Medica exhibition. Noninvasive cardiac output monitoring is one area of growing interest, with growing acceptance of that technology in particular for alternate site applications such as the physician's office. New noninvasive cardiac output monitoring technologies exhibited at Medica are described in Table 1, along with other technologies for monitoring of cardiac function and blood flow useful in the critical care setting. There is growing interest in technologies that avoid the need for pulmonary artery catheterization to monitor patients in critical care and during surgery. While first-generation, noninvasive approaches for cardiac output monitoring were typically not useful in critical care patients, newer technologies have addressed the factors responsible for poor correlation with invasive cardiac output measurement. In addition, there is growing interest in technologies for measurement of local blood flow and tissue perfusion, particularly during surgery. Certain technologies have now been adopted by leading suppliers of vital signs monitoring equipment. For example, Pulsion Medical recently announced a strategic alliance with Agilent/Philips Medical (Andover, Massachusetts) for use of the PiCCO technology with the Viridia Monitoring System.

Table 1
Noninvasive Cardiac Output/Blood Flow Monitoring Products
Company Product Key Features
Biosonix Ltd.
(Kfar Malal, Israel)
BioFlow Transesophageal dual-beam Doppler ultrasound system for measurement of blood volume flow; applications in measurement of peripheral/carotid blood flow; blood flow monitoring during open-heart surgery; and cardiac output measurement.
Hand-held intra-operative blood flow monitoring probe; employs angle-independent dual-beam blood flowmetry, a Doppler ultrasound-based technology, to quantitate blood flow in selected vessels. Also measures blood flow velocity, dynamic velocity profile, waveforms and vascular diameter in real time. Applications in cardiac and vascular surgery, organ transplantation.

Imagyn Medical
(Irvine, California)
ECOM Endotracheal bioimpedance/ECG monitor for cardiac output monitoring. Also functions as standard endotracheal tube. Sensors measure electrical changes due to blood flow proximal to bifurcation; ECG provides heart rate.

Innovision A/S
(Odense, Denmark)
Innocor Noninvasive cardiac output monitoring via oxygen uptake measurement.

LEA Medizintechnik
(Gieben, Germany)
Tissue Perfusion
Measures tissue oxygenation by combining pulse oximetry with flow measurement and hemoglobin determination.

(Seoul, Korea)
MyMc Noninvasive blood circulation monitor. Acceleration plethysmography technique indicates increase in blood vessel area. Applications in prognosis of atherosclerosis, evaluation of therapy.

Manatec Biomedical
(Petit-Ebersviller, France)
Physio-Flow Noninvasive hemodynamic monitor. Thoracic electrical bioimpedance technology using six ECG electrodes. Signal morphology analysis technique avoids baseline artifacts. Applications in pulmonary edema, coronary artery disease diagnosis, pacemaker function monitoring and critical care monitoring. Euro 15,000 for complete system.

(Buhl, Germany)
CardioTec 2000 Noninvasive cardiac output using two-view echocardiography data on aortic volume plus CardioTec measurement of contractile reserve. Applications in management of cardiomyopathy, sports training. DM 15,000.

Pulsion Medical Systems
(Munich, Germany)
PiCCO Minimally invasive cardiac output, intrathoracic blood volume, extravascular lung water and cardiac function index using combination of non-cardiac thermodilution and central venous catheter. Avoids use of right heart catheter.
IC-View Minimally invasive tissue perfusion measurement using injected agent (ICG pulsion) plus near-infrared light and fluorescence detection.

Source: Cardiovascular Device Update

CardioDynamics International (San Diego, California) is the leading supplier of noninvasive cardiac output monitoring systems at present. Although most units continue to be placed in physician offices and emergency departments, a new model was launched in July 2001 in partnership with GE Medical Systems targeted at users in the ICU. Sales of that version are slowly beginning to ramp up, indicating that noninvasive cardiac output technology is increasingly moving into the critical care setting.

Electrophysiological monitoring techniques also are finding increased application in critical care monitoring. For example, CNSystems Medizintechnik GmbH (Graz, Austria) has developed the Task Force Monitor that measures autonomous control of heart rate and blood pressure by the brain, an approach that may allow more sensitive detection of changes in cardiovascular function than existing techniques. The Task Force system sells for Euro 38,000 and provides measurements of stroke volume, cardiac output, blood pressure, heart rate and other parameters in real time. The system has applications in non-invasive diagnosis, assessment of autonomic neuropathy, evaluation of response to vasoactive drugs and observation of patients during dialysis procedures. Inomed GmbH (Teningen, Germany) has developed neurophysiological electrodes for monitoring of potentials that can help to identify the optimal sites for placement of electrodes for use in the treatment of Parkinson's disease. Cost of the system ranges from $50,000 to $250,000.

Home, alternate-site monitoring in Europe

A variety of monitoring technologies for use in the home and alternate sites were exhibited at the Medica meeting. One of the most unique devices is the Herz Handy from Vitaphone (Altrip, Germany). The unit is a combination cellular phone and portable patient-use ECG system that allows ECGs to be measured over a 40-second period and transmitted to a physician's personal computer via web connection. ECG waveforms can be recorded at the onset of symptoms and then forwarded from any location with cellular service, improving diagnosis and evaluation of response to therapy. In addition, Vitaphone operates a call center that allows the ECG data to be immediately transmitted to the physician. The patient's physical location also can be determined using the Global Positioning System in emergency situations once the patient calls in. In Germany, for example, the location can be determined to within 15 meters, allowing the nearest emergency medical unit to respond. A cardiologist is on duty at the Vitaphone service center to analyze ECGs in emergency situations and provide instructions for treatment via cellphone. Vitaphone was founded about two years ago and has established the first cell center in Magdeburg in former East Germany. The company sells the phones used by the service for DM 799 per patient (about $360) and charges DM 99 per month (about $45) for the service. So far, about 150 phones have been placed, with an additional 50 in test.

Fukuda Denshi (Tokyo) has developed a POC monitoring system that combines an ultrasound scanner with 12-lead ECG measurement ,in a package priced at Euro 20,000, that can be used in private physician offices, clinics and other alternate-site locations. Another device, introduced by e-med Innovations (Dallas, Texas), combines a digital stethoscope with recording capability and e-mail for remote patient diagnosis. The signals from the stethoscope can be displayed on a computer screen for visual analysis by the physician, or analyzed by listening to the stored audio. In addition, data can be compared with previous records to analyze trends over time. The e-med device is priced at $800, and 510(k) clearance for the product in the U.S. was obtained in September 2001. Eventually, the company plans to add ECG measurement capability to the device. e-med was originally founded in France in 1995 and established its U.S. operations in 1999. About 7,000 e-med electronic stethoscopes have been sold in Europe.

Monitoring of blood pressure in the home and other alternate sites is another application of portable medical electronics that is popular in Europe. As shown in Table 2, the worldwide market for home-use blood pressure monitoring devices is substantial. In spite of the large number of devices sold each year, however, a very small percentage of patients adequately control their hypertension. TensioMed Ltd. (Budapest, Hungary) has introduced an advanced ambulatory blood pressure monitoring system, TensioCare, that serves as a virtual hypertension clinic. The key component of the system is the TensioPhone, a compact, hand-held personal oscillometric blood pressure monitor that is accurate to within 3 mm Hg and can store up to 600 measurements. The device can be connected to the patient's phone line to transmit measurements stored over a typical monitoring period of 24 hours to the TensioCare monitoring center. Another model, TensioMobile, transmits the stored data via wireless infrared connection to a mobile phone and then to the TensioCare Monitoring Center, which generates reports for the physician.

Table 2
Noninvasive Blood Pressure Monitoring Statistics

Number of patients with hypertension 50 million in U.S. alone

Amount spent on care of patients with hypertension $37 billion in U.S. alone

Number of noninvasive blood pressure monitoring devices sold per year, worldwide 11 million

Total worldwide market for noninvasive blood pressure devices $1 billion

Percentage of patients with controlled hypertension U.S. = 24%
Czech Republic = 18%
Canada = 16%
UK = 6%
Russia = 6%
Poland = 4%

Source: Erdine, S., ESH Scientific Newsletter 2000 (1), No. 3; TensioMed Ltd.

The TensioMed system is designed to improve patient management by improving patient compliance with blood pressure reporting. According to a recent study involving 4,431 patients, almost half under-reported their self-measured blood pressure to their physician, and 15% over-reported. By automatically recording pressures, the TensioMed system can help the physician to obtain more accurate blood pressure records and adjust therapy accordingly. TensioMed plans to market the technology as a franchise, with a typical monthly fee of about $25 per patient monitored.

Welch Allyn (Skaneateles Falls, New York) has introduced the QuietTrak Ambulatory Blood Pressure Monitoring System, a $2,000 device used to track blood pressure in patients over a typical period of 24 hours, usually split into two 12-hour sessions. The QuietTrak can be programmed to take readings automatically at preset intervals, usually every 15 minutes, and the stored data can be output to a PC or a printer. The QuietTrak has sold well in Europe, and also in South America, according to the company. However, sales in the U.S. have been slow so far due to a lack of Medicare reimbursement.

Another patient monitoring product, the HTM-1000 from Bionet (Seoul, Korea), provides six- or 12-lead ECG recordings, noninvasive blood pressure, capillary glucose readings and body impedance measurements in a compact $3,000 package that allows control from a standard PC. The device is targeted at applications in physician offices and clinics, where a compact, low-cost multifunction device can be used to perform most of the standard vital signs measurements needed for primary diagnosis.

Home monitoring in Europe is expanding on a number of other fronts. MC Medical (Tokyo) exhibited the AD9110 home care support system. The system collects data via wireless telemetry from Vital Signs Sensors provided by the company and transmits the data using a standard phone line to a PC in the doctor's office. Parameters such as oxygen saturation, blood pressure, temperature and body weight can be recorded. Data can be recorded for up to one week in the patient's home and then transmitted to the physician for review.

HomeFree Systems Ltd. (Tel Aviv, Israel) demonstrated the HomeFree At Home Monitoring System, which is targeted for management of patients with Alzheimer's disease in the hospital, nursing home or the patient's home. The system has been on the market for about one year in Europe, with about 100 installations in hospitals throughout the region. The company is beginning to actively market the system for home use in Germany. The HomeFree device is configured as a wristband that is worn by the patient to guard against wandering in environments where continuous supervision is difficult. A central home monitoring unit automatically communicates with the wristband unit and sounds an alarm on a caregiver's pager if the patient wanders outside of a predetermined range of up to 100 feet. No complicated installation is required. The company now plans to add additional parameters to the system, including pulse oximetry, heart rate and motion detection.

VivoMetrics (Ventura, California) is developing the LifeShirt System, a patient monitoring system that uses a lightweight shirt worn by the patient to monitor vital signs via embedded sensors. Monitored parameters include ECG, oxygen saturation, breathing rate, blood pressure, posture and activity. The company has also developed the VivoReports reporting software and VivoViewer for generating customer reports.