AlluraClarity RfA customer presentation - Philips Healthcare

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14 Νοε 2013 (πριν από 3 χρόνια και 9 μήνες)

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Allura
Clarity
: Industry leading

image quality at a fraction of the dose

For
GSSi

& GSS China only. Not intended for distribution in the United
States.
AlluraClarity

is anticipated to be CE marked in June 2012.

For GSSi & GSS China only. Not intended for distribution in the United States.

2

Dose

a growing concern

ALARA


Obese patients

Image quality

Contrast medium

For GSSi & GSS China only. Not intended for distribution in the United States.

1.
Minimize
the amount of radiation
exposure the physician receives during
the procedure


2.
Minimize the likelihood of scatter
radiation exposure to
staff


4.
Minimize the amount of radiation
exposure the patient receives during the
procedure



7.
Minimize the amount of contrast
agent the patient receives during the
procedure






Radiation dose is still your No. 1 concern

Highest scoring unmet needs

Source: Market study amongst ~300 interventional
cardiologists, radiologists,
electrophysiologists

and surgeons

in Germany and the US

3

For GSSi & GSS China only. Not intended for distribution in the United States.

Your ALARA dilemma


Right image quality to

diagnose and treat accurately

More complex and

longer procedures

Obese and

high
-
risk patients

Reduce dose

for your patient

Reduce dose for
yourself and your staff

4

For GSSi & GSS China only. Not intended for distribution in the United States.

5

Patient Dose

Required Image Quality

Characterization

Localization

Allura
Clarity

Allura Xper

With
Allura
Clarity

we’ve changed the equation

For GSSi & GSS China only. Not intended for distribution in the United States.

6

Industry leading image quality

at a fraction of the dose

Philips AlluraClarity

A revolutionary new
generation of X
-
ray systems
setting a new standard in
interventional imaging



For GSSi & GSS China only. Not intended for distribution in the United States.

In an interventional application, the AlluraClarity Series an equivalent similar diagnostic image quality in digital subtract
ion

neuro
-
angiographic exams at an average of 73%*
lower X
-
ray dose compared to the previous default settings.

* In a clinical study, the measured dose reduction ranged from 70%
-
75% at 2 frames per second.

NOTE: In clinical practice, the use of AlluraClarity Series , the X
-
ray dose reduction may vary, depending on the clinical task,

patient size, anatomical location, and clinical
practice. To determine the appropriate X
-
ray dose to obtain diagnostic image quality for the particular clinical task, please co
nsult your physicist or radiologist.

Same IQ at 73% less X
-
ray dose*!


Allura Xper

Allura
Clarity

with 73% less dose

7

Images courtesy
Karolinska

University Hospital, Stockholm,
Sweden. Two
separate injections: iodine not fully comparable


For GSSi & GSS China only. Not intended for distribution in the United States.

8

Validation by clinical trials

Neuro


Dr.
Söderman
,
Karolinska

University
Hospital, Stockholm*


Cardiac

Prof.
Reifart
, Main
-
Taunus Cardiac
Centre, Bad
Soden
, Germany**


Endovascular



Dr. van Strijen, St Antonius hospital,
Nieuwegein
, the Netherlands**


* The equivalent image quality for
Neuro

Digital Subtraction Angiography
(DSA) exams can be acquired at an average of 73% lower X
-
ray dose.

** Clinical studies are currently ongoing to establish dose reduction claims
for Cardiac and Endovascular DSA with equivalent image quality. The
average x
-
ray dose reduction claims for Cardio and Endovascular DSA are
anticipated to be 50% and 83%, respectively.

For GSSi & GSS China only. Not intended for distribution in the United States.

Expected to reduce X
-
ray dose by an average of 50% with
equivalent image quality for diagnosis in cardiac angiography




Allura
Clarity

Allura

Xper

All images courtesy of prof. dr. N.
Reifart
,
Main
-
Taunus
Cardiac Center, Bad
Soden
, Germany

9

For GSSi & GSS China only. Not intended for distribution in the United States.

Expected to reduce the X
-
ray dose by an average of 83% with
equivalent image quality for diagnosis in Endovascular DSA



10

Allura
Clarity

Allura

Xper

Image courtesy of
dr
. van
Strijen
, dr.
Vos
, St. Antonius
Ziekenhuis
,
Nieuwegein
, The Netherlands

For GSSi & GSS China only. Not intended for distribution in the United States.

Expected to reduce the procedural X
-
ray dose by an average

of 50% with adequate image quality for all ablation procedures



11

Image courtesy of Image courtesy of dr. Dekker,
Catharina
-
ziekenhuis
, Eindhoven, The Netherlands

Image courtesy of dr. Dekker, Catharina
Ziekenhuis
, Eindhoven, the Netherlands

Allura
Clarity

Allura

Xper

For GSSi & GSS China only. Not intended for distribution in the United States.

Acquisition
:


MEC approval for the clinical study

(
registration number: 2011/350
-
31/1)


Cross
-
over, single site study
design


Digital Subtracted Angiography (DSA) of the cerebral
arteries were recorded twice on same patient, with the
same projection angles and same SID using a standard
iodinated
-
contrast injection
protocol


The two runs were made with different dose settings:
Complete digital pipeline allows advanced Image
Processing

-
First run with regular (100%) settings, without new
processing

-
Second run with reduced dose (75% reduced) settings,
with new
processing


20 adult patients included, complete frontal and lateral
runs from each
patient

Reading
:


Randomized and de
-
identified images were read by three
experienced
neuro

radiologists/surgeons


Overall Image Quality (IQ) is the sum of rating (scale 1
-
5)
of the three characteristic flow phases of the cerebral
arteries (arterial, capillary and venous
)


12

Clinical trial approach
Karolinska

Mean (SE) overall IQ score

For GSSi & GSS China only. Not intended for distribution in the United States.

13

Unique
ClarityIQ

technology: touches every part of the
Allura
Clarity

system from tube to display


Industry
-
leading image quality at a fraction of the
dose with
ClarityIQ

technology

For GSSi & GSS China only. Not intended for distribution in the United States.

Powerful image processing technology

Overview:
AlluraClarity

vs

Allura

Xper

1.
Automatic
Motion Control [AMC]


Better reduction
of motion
artifacts

in DSA (moving
patient or table)


2.
Motion compensation


Enables the use of stronger temporal
noise
reduction
on moving objects
(e.g. heart beat)


3.
Noise reduction


Better noise reduction allows less X
-
ray dose for
equivalent image quality


4.
Image enhancement


More flexibility to adjust contrast, brightness &
sharpness,
etc.


Which elements are used depends upon the

clinical
application


14

For GSSi & GSS China only. Not intended for distribution in the United States.

15

Flexible digital imaging pipeline

For GSSi & GSS China only. Not intended for distribution in the United States.

16

Flexible digital imaging pipeline

For GSSi & GSS China only. Not intended for distribution in the United States.

17

Clinically
fine
-
tuned
parameters

Tuning
done with leading centers in the world

Image Processing parameters

Strength of Noise Reduction

Automatic
Motion
Control

Parameters for Edge Enhancement

Tube parameters

Pulse
time, mA,

copper
filtration

Detector parameters

Detector dose

Sensitivity

Pixel binning

For GSSi & GSS China only. Not intended for distribution in the United States.

Patient dose reduction: how?

18

Through powerful Image Processing, we
obtain equivalent Image Quality with lower
detector
energy





We use this to lower the patient
X
-
ray dose




As an extra benefit, sharpness
is

increased
:


Shorter pulse time
-
> less motion blur


Small focal spot
-
> less focal spot blur



For GSSi & GSS China only. Not intended for distribution in the United States.

19

Clinically fine
-
tuned parameters

Neuro

DSA

Allura

Xper

Neuro

DSA

Allura
Clarity

Neuro

DSA

Focal spot

Large

mA

↓=> S
mall focal spot

(~50% reduced dose)

Cu Filter

None

0.1

(
~50% reduced dose)

Dose

~75% reduced dose

Image Quality

Reduced motion

artifacts with AMC

Sharper due to small
focal spot

Before

After

For GSSi & GSS China only. Not intended for distribution in the United States.

20

Clinically fine
-
tuned parameters

Cardiac
Fluoro


Allura

Xper

cardiac

Fluoro

Mid

Allura
Clarity

cardiac

Fluoro

Mid

Cu Filter mm

0.1


0.4

Pulse width ms

7

7

Dose

~50% reduced dose

Image Quality




Before

After

Allura
Clarity

cardiac

Fluoro

Low (default)

0.4

3.5

~75% reduced dose

Sharper due to
shorter pulse times
(less motion blur)

For GSSi & GSS China only. Not intended for distribution in the United States.

21

Clinically fine
-
tuned parameters

Cardiac Cine

Allura

Xper

Cardiac
Cine

Allura
Clarity

Cardiac

Cine

Cu Filter mm

None


0.1

Dose

~50% reduced
dose

Before

After

For GSSi & GSS China only. Not intended for distribution in the United States.

22

First feedback from physicians

“We were willing to accept that the
image quality would decrease
because we thought 75% dose
reduction was so significant. But it
turned out that image quality
actually improved.”

Dr.
Söderman
, Stockholm, Sweden


“This vessel definition is better”;

“Can you do it with
fluoro

too?
Fantastic”

Dr.
Tarr
, Cleveland, USA


“This is definitely better”; “So real”;
“Is it real?”

Dr.
Wakhloo
, Worcester, USA




Dr. van
Leersum

St Antonius Hospital,
Nieuwegein
,

the
Netherlands

For GSSi & GSS China only. Not intended for distribution in the United States.

Patient
safety

Staff safety

Treatment
options

23

Allura
Clarity

with
ClarityIQ

technology:

Your ALARA freedom

Expand your treatment options

Longer and more complex procedures for
challenging


cases such as pediatric,
geriatric and obese
patients


Improve patient safety

Lower X
-
ray radiation dose
exposure


Improve staff safety

Less scatter X
-
ray radiation dose exposure
for physicians and staff




For GSSi & GSS China only. Not intended for distribution in the United States.

24

Industry leading image quality

at a fraction of the dose

Philips AlluraClarity

Every
day, for every
procedure, every time

you
step on the
foot pedal