Customer Meeting

Biotronik_TitleSlide
_Subtitle
Stockholm
27.10.2014
 Overview

 4F Solutions
BIOTRONIK´s unique 4F portfolio

 Peripheral SE stents
Pulsar-18/ Pulsar-35

 Peripheral balloon catheter family

Passeo-14/ Passeo-18/ Passeo-35

 Peripheral Drug Releasing Balloon

Passeo-18 Lux

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Document identifier
BIOTRONIK // Peripheral Vascular Intervention

4F Solutions „Minimal is Optimal“

Features
Features andand
Benefits
Benefits
4
 Who benefits?

Clin
ica
(Pr l pr
es e
nte
 Smaller ove
puncture hole
da
tC o f
Patient  Less wound c on
IRS complications (haematoma)
E2
013 cep
 Day case intervention ) t w convenient, less chance of cancellation
– more
ith
 Vessel preserved for future intervention4E
VE
RS
tud
y
 Technical success improved – low crossing profile 2 4-m
(6F vs. 4F)
Physician  Productivity increase – less cancelled cases (day case) onth
dat
 No closure device – faster, lower cost, less wound site complications a

 Unique minimal invasive 4F portfolio

BIOTRONIK  0.014"/0.018"/0.035"; Rx/OTW; PTA/SE/BE
 All SFA/BTK devices are 4F*

5 *Except some longest balloon sizes of Passeo-18

BIOTRONIK // Peripheral Vascular Intervention

Pulsar-18/ Pulsar-35

Family of
Self-
expanding
Nitinol Stents
 Challenges in the SFA

 Diffuse disease
 Often long lesions (>20cm)
 Multilevel- SFA and popliteal
 Multiple forces at play
 Compression
 Extension, contraction,
 Extreme bending
 Calcified, occluded

7
 Changes in the SFA

Vessel dynamics

Mid-SFA Distal-SFA Popliteal

70/20 (Shortening) 5% 14% 9%

90/90 (Shortening) 10% 23% 14%

 Stiffer stents will cause that part of the artery to be able to move less.
The remaining un-stented part of the artery then needs to move more
than usual to compensate
 Ideal stent would have sufficient radial force to hold open the lumen
but not more than this otherwise the force on the vessel wall results in
a increased re-stenotic “response”

Source: H.Bob Smouse: Changes in peripheral arteries during

joint move-
8 ment before and after stent placement in the Cadaver model
 Changes in the SFA
Femoro-Popliteal Bending

0 70/20 90/90

Source: H.Bob Smouse: Changes in peripheral arteries during

joint move-
9 ment before and after stent placement in the Cadaver model
 The Pulsar Family
Indications

 Femoral artery
 Infrapopliteal arteries
 (BTK; Below The Knee)
 (Geniculate)
 (Tibial)

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 Pulsar-18
0.018” OTW Nitinol Stent with Single Handle Release

Technical Data
 SDS: 0.018“; OTW; 90/135 cm
 Sizes: Ø: 4-5-6-7 mm;
L: 20-30-40-60-80-100-120-150-170-200 mm
 Schaft: 3.6F; hydrophobic coating
 Stent: Nitinol; 6 electroplated gold markers each end; PROBIO ® coated
 Sheath: 4F
 Strut thickness: 140 ųm
 Strut width: 85 ųm
 UBD: 3 years

mm 20 30 40 60 80 100 120 150 170 200

4 4F
5
6
7

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 Pulsar-35
0.035” OTW Nitinol Stent with Single Handle Release

Technical Data
 SDS: 0.035“; OTW; 90/135 cm
 Sizes: Ø: 5-6-7 mm;
L: 30-40-60-80-100-120-150-170-200 mm
 Shaft: 6F; hydrophobic coating on all 3 shafts
 Stent: Nitinol; 6 gold markers each end; PROBIO coated
 Sheath: 6F
 Strut thickness: 140 ųm
 Strut width: 85 ųm
 UBD: 3 years

mm 30 40 60 80 100 120 150 170 200

5
6
7 6F

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 Device Overview

Guide wire lumen and

flushing port

Safety tab

Trigger

Nitinol stent Radiopaque tip

Stent deployment 4/6F Shaft

marker

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 Bending Stiffness
Comparison Of Stents

Pulsar and Lifestent best bending flexibility

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 Stent Design

Peak-to-Valley vs. Peak-to-Peak

Astron Pulsar Competitor

Peak-to-Peak design will result in strut overlap in the inner radius (fish-scaling*)

15 * Source = Institut for Implant-technology and Biomaterials (IIB), Rostock/ Warnemünde

 Enhanced Radiopacity

6 markers at each end

Gold electroplated layer: Less than 20 micron thickness

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 The Pulsar Technologies:
The right stent for every need
Pulsar-18
 0.018” OTW
 SFA/BTK
 Strut thickness 140 µm
 Strut width: 85 µm
 Sizes: Ø: 4-5-6-7 mm;
L: 20-30-40-60-80-100- 120-
150-170-200 mm
 Catheter: 90-135cm
 Single-handed release handle
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Pulsar-35
 0.035” OTW
 SFA
 Strut thickness 140 µm
 Strut width: 85 µm
 Sizes: Ø: 5-6-7 mm;
L: 20-30-40-60-80-100- 120-
150-170-200 mm
 Catheter: 90-135cm
 Single-handed release handle
BIOTRONIK // Peripheral Vascular Intervention

Passeo-14/ Passeo-18/ Passeo-35/ Passeo-18 Lux

Family of Benefits
Features and
0.018” OTW
Peripheral
Balloon
Workhorse Catheter
and
Drug Releasing
Balloons
 Overview

NEW!

Passeo-14 Passeo-18 Passeo-35 Passeo-35HP Angiosculpt Passeo-18 Lux

ILIAC  
SFA     
BTK    
AV Access   
Long lesions     
Resistant lesions     

Popliteal Lesions     
Restenotic lesions   

 Designed for indication/lesion type

 Some utility for indication/lesion type

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Passeo-18 Lux

0.018” OTW
Features and
0.018” OTW
Benefits

Drug Releasing
Balloon Catheter
Balloon
 Proven Lux Technology meets
Unique Performance Features

Drug
Excipient Balloon

 Paclitaxel (3 µg/mm²)  BTHC (Butyryl-tri-  Well established

hexyl Citrate) Passeo-18 platform
 Anti-proliferative
lipophilic and allow  Keeps paclitaxel in  Available in diameters
fast absorption micro-crystalline 3.0 – 7.0 mm and
structure lengths 40 – 120 mm
 Degrades to citric acid  Innovative insertion aid
and alcohol
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 Paclitaxel:
Proven drug, proven formula

Properties:
 Highly lipophilic, crystalline powder Drug
 High lipophilicity allows uptake in lipid rich environments like
atherosclerotic plaque
 Inhibits smooth muscle cell proliferation by binding to the
cells - interrupting the cell cycle and preventing replication
 Low doses arrest cell division

Areas of application:
 Chemotherapeutic substance
 Medical industry (DES, DEB coatings)

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 Safe and biocompatible excipient

Our drug carrier is commonly used in other

medical and consumer applications
Excipient

 Drug carrier (excipient) we use is called

Butyryl-Tri-Hexyl Citrate (BTHC)
 Degrades to citric acid and alcohol
 Used in medical devices & cosmetics
 Approved also for use in blood contact
(blood bags)

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1
European Commision SCENIHR Report Feb 2008
 Why an Excipient?

How would you salt an egg?

Using a clump ? Or using powder

We have only few seconds to transfer Paclitaxel

to the vessel wall – we need a „powder“ of
Paclitaxel.

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 Why an Excipient?

How do you keep the salt from clumping

(in a humid environment)?

Do nothing?
 No salt!

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 Why an Excipient?

How do you keep the salt from clumping (in a humid

environment)?

 The rice is added to salt to keep it a

powder

Add ’excipient’ rice  The excipient is added to PTX to keep

it microcrystalline

 This structure of the PTX allows it to

be effective

 “Excipient”: pharmaceutical term for

additive (“Hilfsstoff”) to a drug product

26  It works
 Passeo-18 Lux: Device Specifications

Catheter type OTW

Recommended guide wire 0.018"
Tip Short, tapered Balloon
Balloon markers 2 swaged markers (zero profile)
Shaft 3.8F, hydrophobic coated
Usable length 90 and 130 cm
Introducer size 4F (ø 3.0 - 4.0 mm); 5F (ø 5.0 - 7.0 mm)
Nominal Pressure (NP) 6 atm
Rated Burst Pressure (RBP) 15 atm (ø 3.0 - 5.0 mm); 12 atm (ø 6.0 - 7.0 mm)

COMPATIBILITY Catheter 90 cm Length (mm) Catheter 130 cm Length (mm)

ø (mm) 40 80 120 40 80 120
3.0 370843 370848 370853 370858 370863 370868
4F 4.0 370844 370849 370854 370859 370864 370869
5.0 370845 370850 370855 370860 370865 370870

5F 6.0 370846 370851 370856 370861 370866 370871

7.0 370847 370852 370857 370862 370867 370872
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 SafeGuard Insertion Aid
Improves ease of handling and protects coating and physician during device preparation.

Design of SafeGuard Insertion Aid

Distal end Raised Portion Crimped End

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 Passeo-18 Lux
Insertion Aid

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 SafeGuard Insertion Aid
Ease and Safety of Handling

94%

 Protects the user and coating from contact and damage

 Reduces drug loss due to friction with the introducer sheath valve by up
to 94%
 It is pre-mounted on the balloon and does not require any preparation
prior to use

30 *Passeo-18 Lux 4/120/130 with Cordis Avanti Plus 4F, 11 cm, w & w/o SafeGuard insertion aid
 Lux coating technology

Micropipetting
 Folded balloon is mounted on a spindel and turned slowly
 A micropipette is moved along the balloon device delivering a measured
amount of drug/excipient to the surface of the device
 A homogeneous coating is formed on the outer surface of the balloon and
further coating is wicked into the folds of the balloons
 Sensors measure any loss that occurs to ensure proper dosage

Coating is fed into micro-

pipette in a steady stream

Flow Control

32 Droplet Sensor
 Passeo-18 Lux Clinical Trial Program

Primary
Study Device(s) Indication Design CCI(s)
Endpoint

Passeo-18 Lux EU multi-center FIM RCT LLL at 6

SFA D. Scheinert
vs. Passeo-18 (60 pts/5 sites) months

MAE at 1
Passeo-18 Lux EU multi-center FIM RCT
BTK month T. Zeller
vs. Passeo-18 (72 pts/6 sites)
PP at 6 months

MAE at 6
Global multi-center All-
Infrainguinal months
Passeo-18 Lux comers Registry G. Tepe
Arteries FTLR at 12
(min. 700 pts/55 sites)
months

* Passeo-18 Lux EU multi-center Single-arm PP at 12

SFA M. Bosiers
+ Pulsar-18 trial (120 pts/5 sites) months

* Passeo-18 Lux AV Fistula Canadian multi-center RCT LLL at 6

E. Terasse
vs. PTA Access (120 pts/4 sites) months

* PP at 12
Passeo-18 Lux Australian Single-arm trial months
SFA P. Mwipatayi
+ Pulsar-18 (100 pts) PP at 24
* months

Australian Retrospective
In-stent PP, FTLR, MAE P. Myers*
Passeo-18 Lux registries
restenosis at 6 months D. Robertson°
*Investigator-Initiated Trials (35* pts / 29° pts)

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 Major amputations at 6 months
Adjudicated by an independent Clinical Events Committee

38 p* < 0.05 significant

Preliminary data, database not locked yet
 BIOLUX P-III All-comers registry will
also collect important BTK data

Study Design 600 patients in c.40 clinical sites in:

CENEMEA and MIDWEST (pending ‘call for
DESIGN: centres’)
Prospective, international, multi-centre, open
First patient inclusion: Q2/3-2014
label, all-comers registry to expand and
understand the safety and efficacy data on the
Passeo-18 Lux DRB in a real world population of
subjects with obstructive disease of the
infrainguinal arteries.
Passeo-18 Lux

PRINCIPAL INVESTIGATOR:
TBD
6 months: MAE, change in ABI, RC
PRIMARY ENDPOINT:
Freedom from clinically-driven target lesion
revascularization (TLR) within 12 months post-
index procedure.

12 months: freedom from TLR, primary

SECONDARY ENDPOINTS: (selected)
patency, MAE, change in ABI
Freedom from clinically-driven target lesion
revascularization (TLR) within 24 months post-
index procedure
Primary patency at 12 and 24 months
Major Adverse Events (MAE) at 6, 12 and 24
months
24 months: freedom from TLR, primary
Quality of Life (QOL) assessment questionnaires:
Pain scale, SF-12, WIQ at 6, 12 and 24 months.
patency, MAE, change in ABI

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Passeo-18/-35

Features and Benefits

0.018”
0.018“/OTW
0.035“
Balloon Catheter
OTW Balloon
Catheter
 Indications

 Femoral artery
 Iliac Artery
 Popliteal artery
 Infrapopliteal arteries

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 Passeo-18
Specifications Overview

 Catheter: 0.018”; OTW; 90/130/150 cm UL

(150cm only available in 2.0mm diameter)
 Sizes: Ø: 2.0-2.5-3-3.5-4-5-6-7 mm;
L: 20-40-60-80-120-150-170-200 mm
 Shaft: 3.8F; coaxial, hydrophobic, transparent
 Balloon: SCP; controlled compliance, 5-fold
Hydrophobic patchwork coated, 2 markers; coloured tip
 NP: 6 atm
 RBP: 12 atm Ø 5.0mm x 150, 6.0-7.0mm
13 atm Ø 4.0-5.0mm x 170-200
14 atm Ø 2.0-3.5mm x 200
15 atm Ø 2.0-3.5mm x 20-170, 4.0mm x 20-150, 5.0mm x 20-120
 Sheath: 4F: Ø 2 – 7 mm;
5F: Ø 6 x 120 - 200 mm; Ø 7 x 80 - 200mm
 UBD: 3 years
4F 5F
mm 20 40 60 80 120 150 170 200
2.0            
2.5            
3.0            
3.5            
4.0            
5.0            
6.0            
7.0            
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 Passeo-35
Specifications Overview

Catheter: 0.035”; OTW; 80/90/130 cm UL

Sizes: Ø: 3-4-5-6-7-8-9-10 mm;
L: 20-40-60-80-100-120-150-170-200 mm
Shaft: 5F; Bi-lumen, Hydrophobic coating, transparent
Balloon: SCP; controlled compliance, 2 markers, colored tip,
hydrophobic patchwork coated
NP: 7 atm
RBP: 20 atm – 11atm (see compliance chart for details)
Sheath: 5F: Ø 3-7 mm; 6F: Ø 8-10 mm
UBD 3 years
mm 20 40 60 80 100 120 150 170 200
3
4
5
6 5F
7
6F
8
9

10

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 Patchwork Coating

Balloon is fully coated when folded and only partly

coated when inflated

Enhanced crossability
whilst minimizing slippage during
inflation.

5-fold balloon
(2-fold only for 170 mm balloons)

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Passeo-14

Features and Benefits

0.014“
0.018” OTW
0.018“ OTW
OTW
Balloon
Balloon Catheter
Balloon Catheter
Catheter
 Indications

Indikationen
 Popliteal artery
 Infrapopliteal arteries

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 Specifications

 Catheter: 0.014”; OTW; 90/120/150 cm UL

 Sizes: Ø: 1.5-2.0-2.5-3.0-3.5-4.0 mm;
L: 20-40-70-100-140-180-220 mm
 Shaft: 3.9F; coaxial, hydrophobic, transparent
 Balloon: SCP; controlled compliance, 3-fold
Hydrophilic patchwork coating, 2 markers; colored tip
 Distal Shaft: 3.1F; Super Flexible; 150mm (Ø1.5/2.0x20-100) & 75mm (Ø2.0x140-220/Ø2.5-4.0)
 NP: 7 atm
 RBP: 14 atm: Ø 1.5-4.0 mm
 Sheath: 4F

UL (cm) mm 20 40  70 100  140 180 220

120 / 150 1.5

120 / 150 2.0

90 / 150 2.5

90 / 150 3.0
4F
90 / 150 3.5

90 / 150 4.0

150mm distal shaft

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 Innovative Constructions

SCP; 3-folding 3,0 F; 150/75mm, 3.8 F; coaxial,

Outer shaft
Hydrophilic patchwork Hydrophilic coating Hydrophobic coating
Inner shaft
coating Stiffening wire
Stiffening Wire

 Enhanced pushability Cross-sectional view

Proximal Shaft
 Highly kink resistance
48
 Hydrophilic Patchwork Coating

Balloon is fully coated when

folded and only partly
coated when inflated

Enhanced crossability
whilst minimizing
slippage during inflation

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 Hydrophilic Coating

Before inserting the Passeo-14 balloon catheter into the patient, the balloon
needs to be immersed in saline for 20 – 25 seconds. This is required to
activate the Hydrophilic Coating and gives its slippery properties.

IFU section:

50
 Passeo-14

Feature and Benefits

 Pedal sizes
The 1.5-2.0mm diameter sizes feature longer 150mm distal shaft
for enhanced flexibility when treating dorsal/plantar vessels
 Longer catheter lengths
150cm catheter length in pedal sizes to permit deep
inframalleolar access
 Hydrophilic coating
Balloon and distal outer shaft hydrophilic coated for superb
crossability
 Stiffening wire
The proximal shaft contains a steel wire to aid pushability and
kink resistance
 State-of-the-art balloon material
Semi Crystalline Polymer, with controlled compliance and high
puncture resistance
 3-Fold balloon
Enhanced balloon folding process 3-fold on all sizes allows for a
low profile design (3F)
51
Fortress

Physician
Reinforced
Presentation
Introducer Sheath
System / 4F, 5F, 6F
October 2016
4F, 5F, 6F
 Fortress Reinforced Introducer Sheath
Core messages

 Coil reinforced sheath for kink and deformation resistance

 Radiopaque sheath marker to provide optimal radiopacity

 Hydrophobic coated sheath for easy insertion

1

 Smooth tapered sheath and dilator tip

1
5F and 6F sheath

53
 Fortress is specifically constructed to provide flexibility
and excellent kink and deformation resistance

The Fortress introducer sheaths have a friction lowering PTFE liner with a
polymer embedded stainless steel coil shaft design. This construction
offers great flexibility and kink and deformation resistance.

Polymer cover The Fortress coil reinforced sheath does

not oval when curved – non-ovaling –
Stainless steel coil thus diameter is maintained

PTFE liner Cross section

curved Fortress sheath

Standard competitive non-reinforced

sheath ovals when curved - thus
diameter reduced
Cross section
curved non-reinforced sheath

54
 The Fortress 5F and 6F introducer sheath have a
premounted removable hemostatic valve

Removable hemostatic valve

The removable hemostatic valve on the 5F and 6F sheath is

premounted onto the sheath and can be detached to aid in easy
thrombus aspiration.

Note:
Although the hemostatic valve is tightened during assembly,
before use ensure the hemostatic valve is securely tightened.
4F sheaths are not likely to be used for thrombus aspiration
thus a removable valve on the 4F Fortress is not required.

55
 Fortress versus non-reinforced introducer sheaths

6F Fortress sheath

 Fortress has unmatched kink

resistance and does not oval when
curved maintaining a round cross-
section (ovaling could cause
devices to jam inside)

 Users have commented that the

friction through the Fortress
sheath was very low while a stent
and/or balloon was crossing over
Non-reinforced sheath the aortic-iliac bifurcation

 Fortress provides superb flexibility

and stability for crossing over the
bifurcation

 Fortress has similar inner and

outer diameter (Avanti+)

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 Proven technology, quality engineering
and a culture of excellence

BIOTRONIK

Peripheral Vascular Intervention

57