not only a peripheral stent available in renal sizes
DESCRIPTION
Not only a peripheral stent available in Renal sizes. Specification SDS. Catheter design Guide wire compatibility Usable shaft length Length of RX section Balloon material Prox./distal Shaft diameter Crossing profile Introducer compatibility Guiding Catheter comp. Nominal pressure - PowerPoint PPT PresentationTRANSCRIPT
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Not only a peripheral stentNot only a peripheral stentavailable in Renal sizes... available in Renal sizes...
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Specification SDS
Catheter designCatheter design
Guide wire Guide wire compatibilitycompatibility
Usable shaft lengthUsable shaft length
Length of RX section Length of RX section
Balloon material Balloon material
Prox./distal Shaft Prox./distal Shaft diameter diameter
Crossing profile Crossing profile
Introducer compatibilityIntroducer compatibility
Guiding Catheter comp.Guiding Catheter comp.
Nominal pressureNominal pressure
RBPRBP
Rapid Exchange with NiTi-Rapid Exchange with NiTi-wire reinforced RX-section, wire reinforced RX-section, hypotube shafthypotube shaft
0.014“0.014“
80, 145 cm 80, 145 cm
15 cm15 cm
FLEXITEC™ LPFLEXITEC™ LP
2,3F / 3,5F 2,3F / 3,5F
< 0.065”< 0.065”
5F5F
6F6F
8 bar8 bar
14/15 bar14/15 bar
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Specification Stent
Stent designStent design
Range of diameterRange of diameter
Maximum Maximum expansionexpansion
Range of lengthRange of length
Stent material Stent material
Strut thicknessStrut thickness
Strut widthStrut width
Metal to Artery Metal to Artery RatioRatio
Closed cell, slotted tubeClosed cell, slotted tube
Ø 4.0, 5.0, 5.5, 6.0, 6.5, 7.0 Ø 4.0, 5.0, 5.5, 6.0, 6.5, 7.0 mmmm
7.5 mm7.5 mm
10, 15, 20, 24 mm10, 15, 20, 24 mm
Stainless steelStainless steel
165 µ165 µmm
110 110 µµmm
16% @ Ø 6 mm 16% @ Ø 6 mm
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Hippocampus in DetailHippocampus in Detail
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How does it work? 1/6
Insert 0.014” guidewire through a guiding catheter or long introducer sheath into the renal artery.
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How does it work? 2/6
Advance slowly the Hippocampus stent system through GC or IS into the renal ostium. Since the system shows a
progressive flexibility, coming from the long tip, followed by the long balloon-cone, the guidewire will not be straightened and possibly flipped out of the ostium!
Non-Flip-TipNon-Flip-Tip
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How does it work? 3/6
Advance slowly the Hippocampus stent system through GC/IS into the renal ostium. As soon as the balloon
segment with the crimped stent is advanced through the curve of the GC/IS, the long tip is already inserted in the ostium so the position cannot be lost again.
Progressive FlexibilityProgressive FlexibilitySuperior Vessel Accessibility Superior Vessel Accessibility
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How does it work? 4/6
Position the stent inside the lesion, so that the proximal 1-2 mm of the stent will overlap into the Aorta. Since it will not shorten, this position can be easily maintained during inflation.
Zero Stent-Shortening Zero Stent-Shortening for Precise Positioningfor Precise Positioning
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How does it work? 5/6
Inflate the stent carefully, with slow increasing pressure until a proper dilation of the lesion is achieved. High Pressure BalloonHigh Pressure Balloonfor Optimal Resultsfor Optimal Results
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How does it work? 6/6
Flaring the proximal stent section into the ostium is optional, because this might facilitate any following re-intervention of this renal artery.Ostial Scaffolding CapabilityOstial Scaffolding Capability
Facilitating Re-interventionsFacilitating Re-interventions
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Non-Flip-Tip
Long Non-Flip-TipNon-Flip-Tip with progressive flexibility and minimal entry profile Tip length 7mm
6 folded high pressure balloon
Tight FIX secure crimping
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Progressive Flexibility
Progressive Flexibility on distal balloon segment starting from the long Non-Flip-Tip followed by the Long Cones provides a superior vessel accessibility.
NO balloon overh
ang!
NO balloon overh
ang!
It is t
he long sm
all angle
cone th
at looks l
ike a balloon
overhang!
30°30°
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Stent System Dimensions in Detail
Tip length
7 mm
Stent Ø(mm)
Cone length(mm)
4 5,35 7,2
5,5 8,16 9,0
6,5 10,07 10,9
Stent Ø(mm)
Cone length(mm)
4 5,35 7,2
5,5 8,16 9,0
6,5 10,07 10,9
Rapid Exchange section
15 cm
Stent length
10, 15, 20, 24 mm
Distal shaft Ø
3,5F
Ste
nt I.D
. Ø
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Crossing Profiles
Ø 4.0, 5.5, 6.0 mm 1.45 - 1.48mm (0.0571 – 0.0583”) 0.0577”
Ø 5.0, 6.5, 7.0 mm 1.54 - 1.57mm (0.0606 – 0.0618”) 0.0612”
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Zero Stent-Shortening
Zero Stent-Shortening and precise alignment of the Stent with the proximal marker band enables the operator to precisely position the stent inside the ostium. Proximal Stent
Edge/ Balloon Marker
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Enhanced Pushability
For the normal RX- sections, there will be an increased friction, when passing through the curve of GC
The Ni-Ti wire is straightening the RX- section in order to transfer the maximum of push through the curve.
Push Loss
Push Loss
Tapered NiTi-wire inside the 15 cm long rapid exchange section reinforces the distal catheter section and clearly enhances the pushability.
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Ostial Scaffolding Capability
Ostial section Distal section
Flaring the proximal stent section into the ostium is optional, because this might facilitate any following re-intervention of this renal artery.
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Everything is Possible
Shaft length of 80 and 145 cm enable you to perform radial approaches, which have significant benefits for the patient.
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SDS Compliance
4,00 5,00 5,50 6,00 6,50 7,00
6 3,76 4,77 5,22 5,64 6,13 6,70
7 3,88 4,88 5,36 5,82 6,29 6,85
8 4,00 5,00 5,50 6,00 6,50 7,00
9 4,12 5,11 5,65 6,19 6,68 7,26
10 4,20 5,19 5,73 6,30 6,77 7,38
11 4,26 5,28 5,81 6,40 6,91 7,48
12 4,32 5,35 5,89 6,47 6,99 7,59
13 4,37 5,39 5,95 6,54 7,05 7,68
14 4,43 5,45 6,01 6,63 7,12 7,75
15 4,48 5,51 6,10
Stent Inner Diameter (mm)
Compliance Chart
Pressure (bar)
Nominal, in vitro results; ±5% of balloon diameter. Results do not take into account lesion resistance. Confirm balloon sizing angiographically. Do not exceed RBP
Nominal Pressure
Rated Burst Pressure
Controlled compliance of the FLEXITEC™ HS with high strength balloon material, which ensures a proper Stent deployment including a large working range at high pressures of 14-15 bar.
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Size Mix
Stent Ø - L 10 15 20 24
4.0 5.0 5.5 6.0 6.5 7.0
Usable shaft length: 80 and 145 cm
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Frequently Asked Questions
Why such a long balloon overhang? It’s no balloon overhang, it is a long cones with a small opening
angle for a progressive flexibility from the long Non-Flip-Tip over the Long Cones till the crimped stent segment.
In the common ostial stenting procedures it is NOT acceptable to engage the GC in the ostium, or even advance it through the ostium. NO – TOUCH - PROCEDURE The GC has to remain in front of the renal artery inside the aorta.
Why is the rapid exchange section only 15 cm long? The SDS is dedicated to renal application, where you only have to
reach the renal ostia. That shorter the RX-section is, that higher is the pushability.
What for a NiTi-wire inside the RX-section? To reduce the friction inside the GC/IS and consequentially improve
the pushability.
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Frequently Asked Questions (cont.)
Are there any clinical data available? Not yet for the Hippocampus. But we are about to start a
multicenter (4) registry “PRECISION” (Renal artery angioplasty in Patients with hypertension and renal insufficiency using Hippocapmus renal stent) with the PI Dr. Thomas Zeller from Germany enrolling 50 patients.
The ostial scaffolding capability is not needed! Maybe that this operator does not care about any potential re-
intervention. But without flaring the ostial section of the stent, the engagement of the ostium with a guidewire can become a very tricky procedure.
Why is the guiding catheter compatibility 6F and the introducer sheath comp. 5F? A guiding catheter has always the outer diameter indicated. In
case a long introducer sheath will be used instead of a GC, the inner diameter of the IS is sufficient with 5F.
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Positioning
The Hippocampus is a Renal Stent System of the latest generation.
The design and architecture of the stent AND the delivery system is absolutely dedicated to the renal artery approach or similar anatomies (e.g. mesenteric artery). It is NOT a normal peripheral stent, with a size mix suitable for renal
arteries!
Due to the ease of insertion of the stent system into the renal artery, the product has the potential to reduce the procedural risks
decrease the duration of the procedure
improve the technical success
Hippocampus should be sold on premium price!Hippocampus should be sold on premium price!
Select Properly Where to Go, and Seize the Best Opportunity!