PULSION Medical Systems AG

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PULSION Medical Systems AG
PiCCO2 vs. Edwards EV1000
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Edwards EV1000 Setup
VolumeView sensor VolumeView femoral arterial
catheter VolumeView thermistor manifold CVC
standard TruWave pressure transducer EV1000
clinical platform
Patient Monitor
AP
CVP
Additional transducer for injection detection
is neccessary!
EV1000 basic setting is more complex than a PiCCO
basic setting!
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EV 1000 Hardware
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PiCCO2 vs. EV1000 - Hardware monitor
PULSION PiCCO2 PULSION PulsioFlex Edwards EV1000
Target market segment ICU OR OR, ICU
Design Monitor, modules Monitor, modules Screen, bedbox, modules
Technologies available PiCCOCeVOX LiMON (ProAQT) (PiCCO) CeVOX LiMON ProAQT (CiMON) etc. PiCCO PreSep, PediaSat FloTrac
End-customer price Appr. 15k EUR Appr. 8k EUR Appr. 15k EUR
Battery Yes No No
Screen 13 8 (800x480) 10 (800x600)
Touch screen Yes Multitouch Yes
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Edwards EV1000 Disposables (VolumeView set)
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Edwards EV1000 Disposables (VolumeView Set)
Instructions for use
VolumeView Catheter Set
VolumeView Transducer Set
CVP Transducer Injectate Sensor
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Edwards VolumeView Catheter Set
Nitinol Guidewire
Fancy guidewire dispensor
Suture Kit
Scalpel
5F20cm 4F16cm
3pin PA Connector
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PiCCO2 vs. EV1000 - PiCCO kit vs. VolumeView
Combo kit
PULSION PiCCO kit Edwards VolumeView Combo kit
Pressure sensor Standard DPT Double sensor
Injectate sensor Thermistor plus switch Standard PAC injectate sensor CVP necessary
Catheters available (preliminary status) 5F20 femoral4F22 brachial cubital 4F16 brachial prox 4F8 axillary 3F7 children femoral 4F50 radial 5F20 femoral 4F16 brachial
End-customer price 160-220 EUR Not yet communicated
Additional accessories Needle, dilatorNitinol giude wire Scalpel, suture kit, Steel guide wire ?
Compatibility to competitors platform No No
tested with PiCCO2, Philips Intellivue, Dräger
Smartpod
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PiCCO2 vs. EV1000 - Software GUI / visualisation
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PiCCO2 vs. EV1000 - Software GUI / visualisation
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PiCCO2 vs. EV1000 - Software GUI / visualisation
PULSION PiCCO2 Pulsion PulsioFlex Edwards EV1000
Use via touch screen Yes Yes (Gestures control) Yes
Target ranges adjustable Yes Yes Yes
Visualisation modes SpiderVisionProfile barsTrends Physiology tree (SpiderVision)(Profile bars)Trends ? ? -CockpitTrends Physiology tree Physiology animation
Software architecture Context driven Context driven Menu driven
Event Management No No, planned Yes
LAN connection to hospital network No, planned Network printing HL7planned Yes
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PiCCO2 vs. EV1000 Parameters / algorithms
PULSION PiCCO2 PULSION PulsioFlex Edwards EV1000
Continuous AP with curve Yes Yes No
Continuous CO PCCO PCCO PCCO / Vigileo mix(not yet stable)
Preload volume GEDV (GEDV) GEDVsmart (changed algorithm?)
Lung water EVLW (EVLW) EVLWsmart (changed algorithm?)
Indexing with PBW Yes (patent appl.) Yes No
SVV/PPV standard standard SVVextra
R-L shunt detection Based on manual double hump detection in TD curve Based on manual double hump detection in TD curve Based on manual double hump detection in TD curve
Consideration of lung resection No No (Yes)
Volume site adaptation Yes Yes No?
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PiCCO2 vs. EV1000 - Algorithm differences,
additional features
ELWIsmart compensation after lobectomy Clinical
studies necessary to prove validity and
accuracy, until today three studies on this
topic showing no significant EVLW differences
before and after lobectomy SVVextra Already
in the PiCCO algorithm since PiCCOclassic V4.1
(from 2000) means, the Edwards SVV algorithm
was and is still erroneous
Compensation of arrhythmias in AP Curve 1
Detection 2. Rejection 3. Interpolation 4.
Correct calculation
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Lung Resection Compensation Feature

• Argumentation tips
• Lung tissue is mainly removed if it is damaged,
  mostly by trauma, inflammation or tumors.
• Local lung perfusion is therefore already
  reduced even before resection.
• Where there are local lung perfusion
  disturbances, ELWI is measured as a false low
  before resection,
• because only the perfused parts of the lung are
  integrated into the ELWI measurement.
• So ELWI may be the same before and after
  resection, especially where there is reduced
  local perfusion.
• If a compensation factor for different segments
  of the lung are used in the EV1000,
• ELWI can be changed to any level. There is no
  literature to support this factor.
• It is more objective to measure ELWI before and
  after lung removal, to get accurate
• information about real changes in PiCCO ELWI
• Even if ELWI is altered , the trend and dynamics
  of the PICCO ELWI is are correct!
• Remember only the PiCCO ELWI is indexed to
  predicted body weight ensuring its increased
  accuracy

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PiCCO2 vs. EV1000 - Algorithm differences,
additional features
GEDVsmart, EVLWsmart EV1000 EVLW validation was
done by using PiCCO as gold standard with
excellent agreement, means no significant
improvement in the new algorithm. GEDVsmart
should enhance accuracy in case of a L-R shunt.
No data published regarding this. Right-to-left
heart shunt detection also possible with the TD
curve in the PiCCO, until today only one
publication (letter by Michard), no
quantification of shunt volume or cardiac
output, which was already included in PiCCOplus
V7.1 but skipped in PiCCO2 because of not
proven clinical relevance and accuracy
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Integration and interfacing
Philips
Draeger
GE
Mindray
Spacelabs
Nihon Kohden
Module available (soon)
Parameter connection available
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EV1000 market entry Challenges and advantages

• Edwards confirms the PULSION philosophy of
  heamodynamic monitoring and promotes volumetric
  monitoring, lung water and calibrated pulse
  contour CO
• Edwards has a ME2 device, PiCCO is the original
• PiCCO is already widely spread, also as modules
  for monitors
• In the validation study PiCCO is used as gold
  standard
• Edwards promoters can not anymore argue against
  PiCCO
• Risk for the PiCCO installed base?
• - as US company Edwards will avoid liability
  problems
• - direct promotion of VolumeView sets to be used
  with PiCCO is unlikely
• Risk of price war?
• - Edwards is focusing on high margins and need
  them to achieve ROI