Workhorse Balloon - FLUYDO
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Transcript of Workhorse Balloon - FLUYDO
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Product Presentationand R&D tests
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What the market needs
A-traumatic, extremely flexible and tapered tip: to guide the
balloon catheter through the artery while avoiding any injury to the
vessel wall
Exceptional trackability and crossability: to provide the extremeeasiness in reaching and crossing the most challenging lesions;
and, if necessary, a good re-crossing to optimize the pre-dilation
procedure already performed.
Versatility: 6F kissing balloon compatibility
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What the market needs (I)Tip
A hot topic of the workhorse balloon market segment is
the tip. The requirements coming from physicians are the
TIP features here below summarized:
a-traumatic: There is always the risk of creating an
injury to the vessel wall when a device is inside an artery.
In order to minimize this risk the choice of the material
used to produce the TIP is important.
flexible: A higher tip flexibility means a easier lesion
crossing in bends and reduced fish-mouthing effect witha consequent reduced friction during balloon delivery.
tapered: in case of challenging lesion a true tapered tip
help physicians to cross tight lesions.
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What the market needs (I)
Tip: the CID answer (I)
0.017
4.0 mm
0.11
mm
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What the market needs (I)Tip: the CID answer (II)
Fluydo vs Apex
Fluydo vs Sprinter Legend
Fluydo vs Ryujin Plus
0.0170.018
0.0170.0175
0.017 0.017
0.17 mm
0.13
mm
0.12 mm
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TIP Test Flexibility
Test Description:
The result of this test shows
the force necessary to bend
the tip.
How to read the result:
Lower force means higher
flexibility.
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TIP Test Flexibility Results
*
* The Ryujin Plus Tip kinks after a bending of
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TIP Test Crossability
Test description:The result of this test shows the
force necessary to cross a
simulated lesion from the tip.
How to read the result:Lower is the force necessary to
cross the lesion and better is the
balloon crossability performance.
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TIP Test Crossability Result
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What the market needs (II)Balance Shaft Design: the CID answer (I)
Fluydo was projected and realized with the specific target to help the
physicians to reach and cross the lesion in the easiest way. In
order to get this target, maintaining a good deflation time, Fluydo
design has been fixed as following:
A. Use of a polyamide/ pebax blend for improved catheter flexibility
while maintaining catheter consistence and strength.
B. Parallel exit port.
C. Hydrophilic coating.
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What the market needs (II)Balance Shaft Design: the CID answer (I)
Distal shaft - A
Standard polyamide blends provide catheter strength but lack of
extreme flexibility performance, sometime crucial to track and cross in
tortuous anatomies. The polyamide/ pebax blend allow for improved
catheter flexibility while maintaining catheter consistence and strength.
Standard distal shaft
FLUYDO distal shaft
Polyamide blend
Polyamide/pebax blend
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What the market needs (II)Balance Shaft Design: the CID answer (II)
Parallel Exit Port B (I)
Fluydos exit port has a parallel design to guarantee a better pushability
and a better dye flow injection.
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What the market needs (II)Balance Shaft Design: the CID answer (II)
Parallel Exit Port B (II)
Fluydo
Sprinter Legend
Apex
Ryujin Plus
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What the market needs (II)Hydrophilic Coating: the CID answer (I)
The improved lubricity
and durability of our
hydrophilic coating can
significantly reduce the
friction force.
The CID decision to select ComfortCoatTM, the technologically advancedhydrophilic coating from DSM Biomedical, comes after a carefully evaluationof hydrophilic coatings performsnces in several tests.
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Measurement of the force required to advance a selected device, mountedon to a 0.014 guidewire, in a tortuous path with an incresing bending
curvature (from #1 to #5).
37C water bathTortuous path
Guiding
catheter
Dynamometer
#1
#2
#3
#4
#5
Guidewire
Tested device
The device speed is constant andthe pushing force is recorded ateach curve of the tortuous path.
Device Test Trackability Rationale
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Device Test Trackability Result
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What the market needs (III)Versatility
The balloon versatility is the capability of the device to avoid that the
Physician modifies his procedural strategy because of an initially wrong
device selected.
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With the aim to have an extremely versatile balloon we focus on:
A. Maximal dye flow injection.
B. 6F Kissing Balloon.
Versatility: the CID answer (I)
What the market needs (III)
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What the market needs (II)Versatility: the CID answer (II)
Maximize the die flow injection - A
Following the stents wave of visibility, Fluydo could guarantee the best
lumen possible for the liquid contrast. This characteristic allow a better
visibility during the fluoroscopy.
The best parallel exit port combined with the1.78 F of the distal shaft allow to increase the
lumen till the 38% vs. main Competitors.
Distal Shaft %
Fluydo 1.78 F
Apex 2.1 F 38 %
Ryujin Plus 2.0 F 25 %
Sprinter Legend 1.9 F 13 %
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What the market needs (II)Versatility: the CID answer (II)
Kissing Balloon B (I)
Fluydo can guarantee the characteristic to be used, with the entire
product catalogue, for a 6F kissing balloon technique.
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What the market needs (II)Versatility: the CID answer (II)
Kissing Balloon B (II)
1. 0mm
Fluydo
1.2 mm
Sprinter Legend
1.35 mm
Apex
1.25 mm
Ryujin Plus
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Fluydo Apex Ryuj in Plus Sprin ter Legend Voyager**
Entry profile* 0.017 0.0175 0.018 0.017 0.017
D.O.B. 2.6 F 2.4F 2.5 F 2.4 F 2.4 F
Catheter Lenght 142 cm 143 cm 142 cm 145 cm n.c.
Hypotube 1.78 F 2.1 F 2.0 F 1.9 F 2.8 F
Hydrophilic
coatingYes Yes Yes Yes Yes
Nominal
Pressure6 ATM 6 ATM 8 ATM 6 ATM 8 ATM
Rated Burst
Pressure
14 ATM 14 ATM 14 ATM 14 ATM 14 ATM
Mesurement performed in CID R&D laboratories** Data reoprted on the brochure
Technical Specification
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Market Approach
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Competitors of reference
The main competitors for the workhorse segment are:
Boston Scientific: Apex
Medtronic: Sprinter Legend
Terumo: Ryujin Plus
Abbott: Voyager
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Why market approach?
The following slides will give you some suggestions you could follow tobetter tackle the centers under your responsibility leveraging on the
material that has been presented you in the last minutes.
The basic scheme starts with the easiest centers to approach in function of
the balloon of use and the product portfolio of the related company.
Example:
Workhorse balloon = Voyager
Company balloon portfolio (Abbott)= Voyager + Voyager NC
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Abbott Voyager
Voyager, is the Abbott workhorse balloon. Its one of the oldest product
available and its technical characteristics/performance are no more
considered a gold standard.
If your customers are used to have this product, you can leverage on
the following items:
Technology: Fludyo is our brand new product created to compete withthe most challenging workhorse balloons. Compared with Voyager,
Fluydo is extremely more trackable, flexible and deliverable.
Versatility: The Voyager is not 6F KB compatible with the entire
product range (4.0mm is missing).
Product portfolio: Abbott can not guarantee CID wide range of
balloons (workhorse, high pressure and specialty balloons).
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Boston Scientific Apex
Despite Boston Scientific is the balloon market leader, Apex is
considered a step back vs. Maverick2.
If your customers are used to have this product, you can leverage on
the following items:
Technology: R&D tests have shown that technical characteristics of
Apex are worst in terms of trackability, tip flexibility, lesion crossing.
Versatility: Apex can not be used for the 6F KB technique with the
entire product range (4.0mm is missing); moreover those compatible
require higher force to perform the 6F KB technique.
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Terumo Ryujin Plus
Ryujin Plus is a good workhorse balloon.
If your customers are used to have this product, you can leverage on
the following items:
Technology: R&D tests have shown that technical characteristics of
Ryujin are worst in terms of trackability, tip flexibility, lesion crossing.
Product portfolio: Terumo can not guarantee CID wide range ofballoons (workhorse, high pressure and specialty balloons).
Medtronic Sprinter Legend
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Medtronic Sprinter LegendSprinter Legend is a good workhorse balloon.
If your customers are used to have this product, you can leverage on the
following items:
Technology: as showed in our R&D test the technical characteristics of
Sprinter are worst in term of tip flexibility and lesion crossing.
Product portfolio: Medtronic can not guarantee CID wide range of balloons
(workhorse, high pressure and specialty balloons), moreover the Sprinter
NC is considered a very bad performing balloon.
Versatility: Sprinter can not be used for the 6F KB technique with the entire
product range (4.0mm is missing).
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Conclusions
Fluydo was designed with the objective to compete with the bestperforming workhorse balloons on the market.
Fluydos technical characteristics position this balloon as one of the
best performing workhorse devices and surely the most balanced &
versatile today available.
Fluydo is today part of the CID balloon family (the second largest on
the market) which includes also high pressure and specialty balloons.
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Feel the force of fluidity