BB&T at ISICME 2011

New modality for monitoring lung set to challenge CT, TEE

By JOHN BROSKY

BB&T

BRUSSELS, Belgium – To look into the lungs of a patient already in critical care the current choice is between forcing an ultrasound transducer down the throat or serial radiation exposure with computed tomography.

For a more functional assessment there is a tube to be inserted down the esaphageous, or a rough guess of residual capacity, the amount of air left in the lung at the end of a breath according to the mechanical respirator

Draeger Medical (Lübeck, Germany) recently launched an alternative modality for functional lung imaging, at the International Symposium for Intensive Care and Emergency Medicine (ISICME) the first-ever commercial application of electro-impedance tomography (EIT).

Developed over 10 years, this new monitor for intensive care units (ICU) begins what promises to be an equally long journey for the company on the road to altering clinical practice.

The PulmoVista 500 received a CE mark earlier this month, just in time to be rolled out at the annual International Symposium for Intensive Care and Emergency Medicine being held here this week.

The company said it submitted a 510(k) application for the PulmoVista 500 to the FDA with CT as the predicate technology.

If all goes well with the agency, Draeger said the American introduction for the new monitor will be in Tampa, Florida in November at the International Respiratory Congress of the American Association for Respiratory Care (AARC; Irving, Texas).

The first-to-market EIT device, PulmoVista 500 gives Draeger what company executives estimate to be a six-year lead to challenge incumbent imaging modalities of CT and ultrasound and to establish clinical evidence for its monitor.

The company is hardly ready to launch a multi-center clinical trial with five beta versions of the EIT monitor placed for temporary evaluation in reference centers and just one pre-launch sale, to the University Hospital Leipzig.

Key to Draeger's challenge is an ability to quantify practices for ventilator settings to control positive end-expiratory pressure (PEEP) that today are guided by guesswork and physician preference.

Despite the impressive critical mass of beeping technology surrounding a patient in ICU, mechanical respiration is operator-dependent, only as good as the clinician's experience and theories.

The risk of over- or under-ventilating the patient is pressure damage to the lung tissue or the collapse of the lung.

The PulmoVista 500 provides continuous information about the regional distribution of ventilation within the lung, represented by a dynamic image on the monitor that resemble a map on the Weather Channel or perfusion images from PET.

The clinical benefit is the functional information of EIT that complements morphological images from CT and may replace highly invasive transesophageal echocardiography (TEE).

Where a physician may see an area of concern in the lung with CT, MRI or TEE, the EIT display shows vividly the regional ventilation distribution.

The PulmoVista 500 is expected to have a high clinical value in quantifying effects from changes to mechanical ventilator settings to control positive end-expiratory pressure (PEEP) that currently are operator-dependent based on functional residual capacity (FRC) estimates of the ventilator unit.

Draeger's application of EIT technology, first introduced in 1978, features several unique, and in some cases, innovative features.

Key to the non-invasive monitoring of often frail or fragile patients in ICU is a holter placed around a patient's thorax positioning 16 paired emitter-receivers that are linked in series by a single cable.

The electrodes are placed in direct contact with the skin without the use of gels and can be rapidly deployed for a monitoring session.

In sequence each emitter sends a signal, using the same low voltage as an EEG, that is captured by 14 detectors. Up to 50 sequences of 208 data sets are acquired each second, though only 20 sequences are used for display on the PulmoVista 500.

In addition to the graphic depiction of air distribution in the lung, the monitor displays a quantification of lung capacity in both the dorsal and ventral regions of each lung.

Waveform displays track trends and clinicians can scroll along the waveform to read changes to lung capacity resulting from a recruitment maneuver or therapeutic intervention.

The monitor also calculates the change to lung capacity between two recording sessions displaying regions affected by an intervention.

The PulmoVista 500 is priced against high-end TEE ultrasound, according to Anne-Catherine Grüntges, who heads the marketing efforts for Draeger Respiratory Care in Europe.

POC diagnostics from the U.S. make European debut

Where many new medical devices find their first market opportunities in Europe, point of care diagnostic maker Alere (Waltham, Massachusetts) was swimming against the current introducing the EPOC platform here at the International Symposium for Intensive Care and Emergency Medicine (ISICME).

Alere's point-of-care (POC) analysis system received FDA 510(k) clearance in 2006 for marketing in the U.S., followed by a CE mark approval in 2010.

A wireless, wifi-capable handheld unit, EPOC provides bedside results in 90 seconds using a 92 micro-liter blood sample that yields an analysis across nine measures of blood gas and electrolytes.

The winning feature of EPOC for the critical care and emergency setting are the near-patient, near-immediate results that eliminate a trip to a central lab or processing station.

The platform is built around a smart card technology that is easy to use, low-cost and disposable.

The test cards also do not require refrigeration, allowing them to be stored close to nurses workstation, and have a shelf-life of six months.

Ryan Fenimore, Manager Cardio-Renal with Alere's Cardiovascular business unit, said Italy, France, Germany and the United Kingdom are major markets for Alere in Europe.

The company was also presenting its Triage NGAL test for early recognition of acute kidney injury (AKI).

Bedside testing for a blood biomarker called neutrophil gelatinase-associated lipocalin (NGAL) at the University Hospital of Clermont-Ferrand (France) found a sensitivity of 82% and specificity of 97% in predicting AKI with an elevated blood NGAL level, which was confirmed by traditional clinical markers of AKI 48 hours later.

Developed by Biosite (San Diego), the success of the test resulted in an acquisition of the company by Inverness Medical Innovations, which last year realigned its branding under the new name, Alere.

TB test a favorite with Gates Foundation

“Bill Gates loves our test,“ said Jane Amouyal, the European sales director for Genexpert/Cepheid (Sunnyvale, California) who was presenting the company's Xpert MTB/RIF assay at ISICME.

Developed in concert with the Foundation for Innovative New Diagnostics (FIND; Geneva, Switzerland) with funding from the Bill and Melinda Gates Foundation, the test has demonstrated a high sensitivity for mycobacterium tuberculosis (MTB).

The test recently received a CE mark for distribution in Europe and the application to the FDA is pending, according to Amouyal.

MTB is considered to be under diagnosed today with the World Health Organization reporting over 500,000 new active cases annually in Europe alone.

The multi-drug resistant strains of MTB that have re-emerged require genetic testing not of the patients genotype, but that of the microbial strain to determine if an effective treatment is available.

Even more than the test for tuberculosis, Gates, the founder of Microsoft turned global philanthropist, is enamored with the Cepheid GeneXpert System, according to Amouyal.

“It is lightweight, packs easily and can be operated with a minimum of training,“ she said, making the unit well suited for travel to remote clinics for screening children in villages far from major medical centers.

“This little PCR analysis unit takes the place of 1,000 square feet of laboratory, and the chambers of this plastic test kit replace a separate room used to extract a biological sample, a room dedicated to amplifying the sample, and so forth,“ she said.

A polymerase chain reaction (PCR) diagnostic unit with on-board sample preparation and real-time analysis, the GeneXpert System processes a full menu of tests for noxious pathogens.

Based at the company's European headquarters in Maurens-Scopont, France, Amouyal said Cepheid has placed 800 GeneXpert system in Europe over the past four years.

Novel finger cuff monitor to double sales in 2011

“We are ahead of our target for sales,“ said Walter Habenbacher, global product manager for CNSystems Medizintechnik (Graz, Austria), adding that 2010 finished surprisingly strong and that this year sales are expected to double.

CNSystems presented its novel blood pressure monitoring cuff at ISICME, a small device that stands out for its simplicity among the complex apparatus for emergency and intensive care surrounding it in the exhibition hall.

Unlike traditional blood pressure cuffs that wrap around a patients arm, CNSystems proposes a sensor sleeve placed over two of the patient's fingers to measures arterial blood pressure.

The non-invasive acquisition technique enables continuous monitoring of patients on the CNAP Monitor 500 with real-time displays of blood pressure values, the patient's pulse rate and then a trend view of blood pressure and pulse rate.

This elegantly low-tech approach opens a potential for adding on other technologies, according to Habenbacher.

“We are introducing a measure for stroke volume variation which is a reliable predictor of fluid responsiveness,“ he said.

The new functionality will be onboard the existing system before the end of the year, he said.