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Not only a peripheral stent available in Renal sizes...

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  1. Not only a peripheral stent available in Renal sizes...

  2. 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

  3. 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

  4. Hippocampus in Detail

  5. Insert 0.014” guidewire through a guiding catheter or long introducer sheath into the renal artery. How does it work? 1/6

  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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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!

  13. 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

  14. 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”

  15. 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

  16. 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.

  17. 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.

  18. Shaft length of 80 and 145 cm enable you to perform radial approaches, which have significant benefits for the patient. Everything is Possible

  19. 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.

  20. Size Mix Usable shaft length: 80 and 145 cm

  21. 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.

  22. 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.

  23. 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!

  24. Select Properly Where to Go, and Seize the Best Opportunity!