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 RBP Rapid Exchange with NiTi-wire reinforced RX-section, hypotube shaft 0.014“ 80, 145 cm 15 cm FLEXITEC™ LP 2,3F / 3,5F < 0.065” 5F 6F 8 bar 14/15 bar
Specification Stent Closed cell, slotted tube Ø 4.0, 5.0, 5.5, 6.0, 6.5, 7.0 mm 7.5 mm 10, 15, 20, 24 mm Stainless steel 165 µm 110 µm 16% @ Ø 6 mm Stent design Range of diameter Maximum expansion Range of length Stent material Strut thickness Strut width Metal to Artery Ratio
Insert 0.014” guidewire through a guiding catheter or long introducer sheath into the renal artery. How does it work? 1/6
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! How does it work? 2/6 Non-Flip-Tip
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. How does it work? 3/6 Progressive FlexibilitySuperior Vessel Accessibility
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. How does it work? 4/6 Zero Stent-Shortening for Precise Positioning
Inflate the stent carefully, with slow increasing pressure until a proper dilation of the lesion is achieved. How does it work? 5/6 High Pressure Balloonfor Optimal Results
Flaring the proximal stent section into the ostium is optional, because this might facilitate any following re-intervention of this renal artery. How does it work? 6/6 Ostial Scaffolding CapabilityFacilitating Re-interventions
Non-Flip-Tip • Long Non-Flip-Tip with progressive flexibility and minimal entry profile • Tip length 7mm • 6 folded high pressure balloon • Tight FIX secure crimping
30° 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 overhang! It is the long small angle cone that looks like a balloon overhang!
Tip length7 mm Stent I.D. Ø Distal shaft Ø3,5F Stent length10, 15, 20, 24 mm Rapid Exchange section15 cm Stent System Dimensions in Detail
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”
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
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 Enhanced Pushability Tapered NiTi-wire inside the 15 cm long rapid exchange section reinforces the distalcatheter section and clearly enhances the pushability.
Ostial section Distal section Ostial Scaffolding Capability • Flaring the proximal stent section into the ostium is optional, because this might facilitate any following re-intervention of this renal artery.
Shaft length of 80 and 145 cm enable you to perform radial approaches, which have significant benefits for the patient. Everything is Possible
SDS Compliance • 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.
Size Mix Usable shaft length: 80 and 145 cm
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 - PROCEDUREThe 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.
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.
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!