Transcript Edwards EV1000 - PULSION Medical Systems SE

PULSION Medical Systems SE
PiCCO2 vs. Edwards EV1000
Edwards EV1000 – Setup
VolumeView sensor
VolumeView femoral arterial catheter
VolumeView thermistor manifold
CVC standard
TruWave pressure transducer
AP
CVP
Patient
Monitor
EV1000 clinical platform
Additional transducer 2for injection
detection is neccessary!
EV1000 basic setting is
more complex than a
PiCCO basic setting!
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EV1000 Hardware
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PiCCO2 vs. EV1000 - Hardware monitor
PULSION
PiCCO2
PULSION
PulsioFlex
Edwards
EV1000
ICU
OR
OR, ICU
Monitor, modules
Monitor, modules
Screen, bedbox,
modules
PiCCO
CeVOX
LiMON
(ProAQT)
PiCCO
CeVOX
LiMON
ProAQT
etc.
VolumeView
PreSep, PediaSat
Appr. 15k EUR
Appr. 8k EUR
Appr. 15k EUR
Battery
Yes
No
No
Screen
13“
8” (800x480)
10“ (800x600)
Yes
Multitouch
Target market segment
Design
Technologies available
End-customer price
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Touch screen
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FloTrac
Yes
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 6
Sensor
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Edwards VolumeView – Catheter Set
Nitinol
Guidewire
Guidewire
dispensor
Suture Kit
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Scalpel
VolumeView
Catheter
5F20cm, 4F16cm
3pin TD Connector
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PiCCO2 vs. EV1000 - PiCCO kit vs. VolumeView Combo kit
PULSION PiCCO kit
Edwards
VolumeView
Combo kit
Pressure sensor
Single sensor
Double sensor
Injectate sensor
Thermistor plus
TD start switch
Standard thermistor
CVP necessary
5F20 femoral
4F22 brachial cubital
4F16 brachial prox
4F8 axillary
3F7 children femoral
4F50 radial
5F20 femoral
Catheters available (preliminary status)
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End-customer price
Additional accessories
Compatibility to competitor‘s platform
4F16 brachial
160-220 EUR
Appr. 190 EUR
Needle, dilator
Nitinol guide wire
Scalpel, suture kit,
Nitinol guide wire
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
SpiderVision
Profile bars
Trends
Physiology tree
(SpiderVision)
(Profile bars)
Trends
Cockpit
Trends
Physiology tree
Physiology animation
Context driven
Context driven
Menu driven
No
No, planned
Yes
No, planned
Network
printing
HL7planned
Yes
Visualisation modes
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Software architecture
Event Management
LAN connection to hospital network
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PiCCO2 vs. EV1000 – Parameters / algorithms
PULSION
PiCCO2
PULSION
PulsioFlex
Edwards EV1000
Yes
Yes
No
Continuous CO
PCCO
PCCO
PCCO / Vigileo mix
Preload volume
GEDV
(GEDV)
GEDVsmart
EVLW
(EVLW)
EVLWsmart
Yes (patent
appl.)
Yes
Yes, EVLW only
SVV/PPV
standard
standard
SVVextra
R-L shunt detection
Based on manual double hump detection in TD curve
Continuous AP with curve
Lung water
Indexing with PBW
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Consideration of lung resection
No
No
(Yes)
Volume site adaptation
Yes
Yes
No?
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PiCCO2 vs. EV1000 - Algorithm differences, additional features
GEDVsmart, EVLWsmart
The EV1000 algorithm does not use transit
time analysis but upslope und downslope
of the thermodilution curve to calculate
GEDV and EVLW.
This approach should enhance accuracy in
case of a L-R shunt. No data published yet.
SVVextra
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Compensation of
arrhythmias in AP Curve
1 Detection
2. Rejection
3. Interpolation
4. “Correct” calculation
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Already in the PiCCO algorithm since
PiCCOclassic V4.1 (from 2000), means
the Edwards SVV algorithm was and is
still erroneous
PiCCO2 vs. EV1000 - Algorithm differences, additional features
Right-to-left heart shunt detection
Based on the alternation in the shape of
the TD curve (“camel curve”). This is also
possible with the PiCCO. In PiCCOplus
V7.1 the shunt quantification and correction
of CO was available (based on a scientific
letter by F. Michard) but was not validated.
Skipped in PiCCO2 because of not proven
clinical relevance and accuracy.
letter
ELWIsmart, compensation after lobectomy
Clinical studies are necessary to prove
validity and accuracy. The few studies on
this topic are showing no significant EVLW
differences before and after lobectomy. A
correction might introduce more errors than
improve accuracy.
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Integration and interfacing
Philips
Draeger
GE
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Mindray
Spacelabs
Nihon Kohden
Module available (soon)
Parameter connection available
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EV1000 market entry – Challenges and advantages
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Edwards confirms the PULSION philosophy of heamodynamic monitoring and
promotes volumetric monitoring, lung water and calibrated pulse contour CO
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EV1000 is not even a ME2 device, it offers less than the is the original PiCCO
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PiCCO is already widely spread, also as modules for monitors
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In the Edwards validation study PiCCO is used as gold standard
•
Edwards promoters can not anymore argue against PiCCO
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16 installed base?
Risk for the PiCCO
- Edwards will avoid liability problems (violation of medical device directives)
- promotion of VolumeView sets at the PiCCO sockets is unlikely, no compatibility
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Risk of price war?
- EV1000 is a major investment for Edwards and ROI needs to be achieved
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