workhorse balloon - fluydo

7/28/2019 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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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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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.



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.



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

workhorse balloon - fluydo

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