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Biotronik_TitleSlide
_Subtitle
Stockholm
27.10.2014
Overview
4F Solutions
BIOTRONIK´s unique 4F portfolio
Peripheral SE stents
Pulsar-18/ Pulsar-35
2
Document identifier
BIOTRONIK // Peripheral Vascular Intervention
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
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
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”
0 70/20 90/90
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
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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
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Device Overview
Safety tab
Trigger
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Bending Stiffness
Comparison Of Stents
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Stent Design
Peak-to-Peak design will result in strut overlap in the inner radius (fish-scaling*)
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The Pulsar Technologies:
The right stent for every need
Pulsar-18 Pulsar-35
0.018” OTW 0.035” OTW
SFA/BTK SFA
Strut thickness 140 µm Strut thickness 140 µm
Strut width: 85 µm Strut width: 85 µm
Sizes: Ø: 4-5-6-7 mm; Sizes: Ø: 5-6-7 mm;
L: 20-30-40-60-80-100- 120- L: 20-30-40-60-80-100- 120-
150-170-200 mm 150-170-200 mm
Catheter: 90-135cm Catheter: 90-135cm
Single-handed release handle Single-handed release handle
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BIOTRONIK // Peripheral Vascular Intervention
Family of Benefits
Features and
0.018” OTW
Peripheral
Balloon
Workhorse Catheter
and
Drug Releasing
Balloons
Overview
NEW!
ILIAC
SFA
BTK
AV Access
Long lesions
Resistant lesions
Popliteal Lesions
Restenotic lesions
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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
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
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1
European Commision SCENIHR Report Feb 2008
Why an Excipient?
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Why an Excipient?
Do nothing?
No salt!
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Why an Excipient?
26 It works
Passeo-18 Lux: Device Specifications
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Passeo-18 Lux
Insertion Aid
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SafeGuard Insertion Aid
Ease and Safety of Handling
94%
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
Flow Control
32 Droplet Sensor
Passeo-18 Lux Clinical Trial Program
Primary
Study Device(s) Indication Design CCI(s)
Endpoint
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
* 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
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.
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Passeo-18/-35
Femoral artery
Iliac Artery
Popliteal artery
Infrapopliteal arteries
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Passeo-18
Specifications Overview
10
43
Patchwork Coating
Enhanced crossability
whilst minimizing slippage during
inflation.
5-fold balloon
(2-fold only for 170 mm balloons)
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Passeo-14
Indikationen
Popliteal artery
Infrapopliteal arteries
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Specifications
90 / 150 2.5
90 / 150 3.0
4F
90 / 150 3.5
90 / 150 4.0
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Innovative Constructions
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:
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Passeo-14
Physician
Reinforced
Presentation
Introducer Sheath
System / 4F, 5F, 6F
October 2016
4F, 5F, 6F
Fortress Reinforced Introducer Sheath
Core messages
1
5F and 6F sheath
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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.
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The Fortress 5F and 6F introducer sheath have a
premounted removable hemostatic valve
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.
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Fortress versus non-reinforced introducer sheaths
6F Fortress sheath
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Proven technology, quality engineering
and a culture of excellence
BIOTRONIK
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