HANDBOOK OF
`CORONARY STENTS
`FOURTH EDITION
`
`Editors
`Patrick W Serruys • Benno J Rensing
`
`CRC Press
`Taylor & Francis Group
`
`Page 1
`
`
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex-1802
`Medtronic v. Teleflex
`
`

`

`HANDBOOK OF CORONARY STENTS
`FOURTH EDITION
`Serruys .Reusing
`
`Page 2
`
`

`

`Second edition 1998
`Reprinted 1998
`Third edition 2000
`Reprinted 2000
`
`CRC Press
`Taylor & Francis Group
`6000 Broken Sound Parkway NW, Suite 300
`Boca Raton, FL 33487-2742
`
`First issued in paperback 2019
`
`© 2002 by Taylor & Francis Group, LLC
`CRC Press is an imprint of Taylor & Francis Group, an Informa business
`
`No claim to original U.S. Government works
`
`ISBN-13:978-1-84184-093-2 (hbk)
`ISBN-13:978-0-367-39665-7 (pbk)
`
`This book contains information obtained from authentic and highly regarded sources. Reasonable efforts
`have been made to publish reliable data and information, but the author and publisher cannot assume
`responsibility for the validity of all materials or the consequences of their use. The authors and publishers
`have attempted to trace the copyright holders of all material reproduced in this publication and apologize to
`copyright holders if permission to publish in this form has not been obtained. If any copyright material has
`not been acknowledged please write and let us know so we may rectify in any future reprint.
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`Except as permitted under U.S. Copyright Law, no part of this book maybe reprinted, reproduced, transmit­
`ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented,
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`Trademark Notice: Product or corporate names maybe trademarks or registered trademarks, and are used
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`A CIP catalogue record for this book is available from the British Library
`
`Visit the Taylor & Francis Web site at
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`and the CRC Press Web site at
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`
`Page 3
`
`

`

`13. The GENIC®; GENIC® SV and
`GENIC® LV Stent Systems
`
`Blue Medical Devices B. V., Hehnond, The Netherlands
`Henk JM Meens and Ronald AM Horvers
`
`Description The GENIC® is a balloon expandable coronary stent
`with a helical sinusoidal waveform geometry.
`
`Figure 13.1:
`Structure of the GENIC
`coronary stent.
`
`3
`
`• July—November 1999 development
`• December 1999 completing animal trials
`• December 1999 Development DYLYN®
`• January 2000 CE Mark
`• January 2000 first human implants
`• May 2000 Development SV/LV
`• December 2000 Development drug delivery
`• January 2001 CE Mark SV/LV
`• March 2001 CE Mark DYLYN®
`
`Figure 13.2:
`Expanded 18 mm
`GENIC coronary
`stent.
`
`Page 4
`
`

`

`Henk JM Meens and Ronald AM Horvers
`
`GENIC® coronary stent technical specifications
`
`Material composition:
`
`Radiopacity:
`
`Ferromagnetism:
`
`MRI:
`
`Metallic surface area
`expanded:
`unexpanded:
`
`316 L medical grade
`
`Moderate
`
`N on-ferromagnetic
`
`MRI safe
`
`14% at dia 3,0 mm
`28%
`
`Metallic cross-sectional area:
`
`0.14 mm2
`
`Stent design:
`
`Strut design:
`
`Strut dimensions:
`
`Strut thickness:
`
`Profiles
`expanded:
`crimped:
`
`Longitudinal flexibility
`Balloon/stent assy:
`Expanded stent:
`
`Shortening (expansion):
`
`Expansion range:
`
`Recoil:
`
`Radial force:
`
`Helical sinusoidal waves
`
`Rectangular with rounded edges
`
`0.11-0,12 mm wide
`
`0.10 mm
`
`2.5-4.0 mm
`< 1.0 mm (3.0 X 28)
`
`Excellent
`Excellent
`
`3-4% (3.0 X 18)
`
`2.3-4.5 mm
`
`3-5% (all sizes)
`
`Excellent
`
`Available diameters:
`
`2.5, 3.0, 3.5 and 4.0
`
`Available lengths
`Mounted:
`
`Available sizes:
`
`Recrossability:
`
`Other types:
`
`10, 14. 18. 22 and 28
`
`Full matrix
`
`Excellent
`
`Under development
`
`102
`
`Page 5
`
`

`

`The GENIC®, GENIC® SV and GENIC® LV Stent Systems
`
`GENIC® LV coronary stent technical specifications
`
`Material composition:
`
`Radiopacity:
`
`Ferromagnetism:
`
`MRI:
`
`Metallic surface area
`expanded:
`unexpanded:
`
`316 L medical grade
`
`Moderate
`
`Non-ferromagnetic
`
`MRI safe
`
`14% at dia. 4.0 mm
`30%
`
`Metallic cross-sectional area:
`
`0.17 mm2
`
`Stent design:
`
`Strut design:
`
`Strut dimensions:
`
`Strut thickness:
`
`Profiles
`expanded:
`crimped:
`
`Longitudinal flexibility
`Balloon/stent assy:
`Expanded stent:
`
`Shortening (expansion):
`
`Expansion range:
`
`Recoil:
`
`Radial force:
`
`Available diameters:
`
`Available lengths
`Mounted:
`
`Available sizes:
`
`Recrossability:
`
`Other types:
`
`Helical sinusoidal waves
`
`Rectangular with rounded edges
`
`0.10-0.13 mm wide
`
`0.1 1 mm
`
`4.0-5.0 mm
`s l.l mm (all sizes)
`
`Excellent
`Excellent
`
`4-5% (4.5 X 22)
`
`3.7-55 mm
`
`35-5.5% (all sizes)
`
`Excellent
`
`4.0, 4.5 and 5.0
`
`18, 22 and 28
`
`Full matrix
`
`Excellent
`
`Under development
`
`103
`
`Page 6
`
`

`

`Henk JM Meens and Ronald AM Horvers
`
`GENIC® SV coronary stent technical specifications
`
`Material composition:
`
`Radiopacity:
`
`Ferromagnetism:
`
`MRI:
`
`Metallic surface area
`expanded:
`unexpanded:
`
`316 L medical grade
`
`Moderate
`
`N on-ferromagn etic
`
`MRI safe
`
`14% at dia 4.0 mm
`26%
`
`Metallic cross-sectional area:
`
`0.1 1 mm2
`
`Helical sinusoidal waves
`
`Rectangular with rounded edges
`
`0.08 X 0.10 mm wide
`
`0.09 mm
`
`2.0-2.5 mm
`s 0.9 mm (all sizes)
`
`Excellent
`Excellent
`
`2-3% (2.5 X 14)
`
`1.8-2.8 mm
`
`2.5—4.5% (all sizes)
`
`Excellent
`
`2.0 and 2.5
`
`10, 14 and 18
`
`Full matrix
`
`Excellent
`
`Under development
`
`Stent design:
`
`Strut design:
`
`Strut dimensions:
`
`Strut thickness:
`
`Profiles
`expanded:
`crimped:
`
`Longitudinal flexibility
`Balloon/stent assy:
`Expanded stent:
`
`Shortening (expansion):
`
`Expansion range:
`
`Recoil:
`
`Radial force:
`
`Available diameters:
`
`Available lengths
`Mounted:
`
`Available sizes:
`
`Recrossability:
`
`Other types:
`
`104
`
`Page 7
`
`

`

`The GENIC®', GENIC® SV and GENIC® LV Stent Systems
`
`Tips and tricks for delivery
`
`• The GENIC®' coronary stent is premounted on a semi-compliant, high-
`pressure rapid exchange stent delivery catheter, with optimized
`pushability and distal flexibility, securing reliable performance.
`• The GENIC8' coronary stent is positioned between two platinum iridium
`balloon markers.
`• The GENIC® coronary stent delivery system is compatible with a 5 Fr
`guiding catheter.
`• After delivery the GENIC® coronary stent conforms to the natural
`anatomy of the coronary artery.
`
`Indications for use
`
`• The very flexible GENIC® coronary stent can be applied in a wide range
`of procedures, from straight stent procedures to procedures in complex
`tortuous paths and direct stenting.
`• The GENIC® coronary stent enables side branch access without decrease
`of robustness in the design.
`
`Why I like my stent
`
`• The unique geometric design of the GENIC® combines the well-
`appreciated flexibility of coil stents with the proven robustness of the
`tubular stents. The superb crimping technology enables direct stenting
`even through 5 Fr guiding catheters.
`• The GENIC®' coronary stent is designed to provide optimal flexibility
`mounted on the stent delivery system.
`• Due to this optimal combination, the GENIC® coronary stent and its
`stent delivery system has an extremely low profile and an excellent
`crossing performance.
`• The helical sinusoidal waveform geometry conforms to the natural
`dynamic tortuous coronary anatomy and prevents stretching of the
`vessel. This excellent flexibility allows placement in very dynamic
`coronary anatomy with less stress on the coronary vessel wall preventing
`restenosis at the extremities.
`
`105
`
`Page 8
`
`

`

`Henk JM Meens and Ronald AM Horvers
`
`Figure 13.3:
`Flexibility of the
`GENIC coronary
`stent delivery
`system.
`
`(«)
`
`(b)
`
`Figure 13.4: (a) Complete stenosis in tortuous proximal right coronary artery;
`(b) after GENIC stent implantation. This shows the excellent coirformability to the vessel
`wall of the expanded stent.
`
`106
`
`Page 9
`
`

`

`The GENIC®, GENIC® SV and GENIC® LV Stent Systems
`
`(a)
`
`(b)
`
`Figure 13.5: (a) Total occlusion of proximal right coronary artery; (b) after
`recanalization and GENIC stent implantation.
`
`Delivery device of GENIC®
`
`Mechanism of deployment:
`
`Balloon expandable
`
`Minimal internal guiding catheter:
`
`Maximal guidewire diameter:
`
`System:
`
`Design:
`
`Proximal shaft:
`
`Distal shaft:
`
`Number of markers:
`
`Type of markers:
`
`Position of markers:
`
`Position stent:
`
`Balloon material:
`
`Compliance:
`
`Nominal:
`
`0.056 inch
`
`0.014 inch
`
`Rapid exchange
`
`Hypo tube
`
`2.1 Fr
`
`2.6 Fr
`
`2
`
`Platinum iridium
`
`Proximal and distal balloon
`
`Between balloon markers
`
`Acrylon® (thermoplastic elastomer)
`
`Semi-compliant, high-pressure
`
`6 atm
`
`Rated burst pressure:
`
`16 atm (> 4.0 mm: 14 atm.)
`
`GENIC® is a registered trademark of Blue Medical Devices
`
`107
`
`Page 10
`
`

`

`‘1"ng jt'mTtN'I'“ CORONARY STEN'I' RANGE
`”———————.
`
`JOSTENT® Coronary Stent Graft
`
`
`
`a Description
`
`
`
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`
`Page 11
`
`Page 11
`
`

`

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`Page 12
`
`Page 12
`
`

`

`17. The Lunar Coronary Stent
`System
`
`InFlow Dynamics AG, Munich, Germany
`Franz R Eberli and Stephan Windecker
`
`Definition
`
`History
`
`Starflex design is a homogeneous, multicellular stent
`structure with alternating stiff and flex segments for
`excellent longitudinal flexibility; the Niobium alloy stent
`is coated with iridium oxide, which facilitates the
`growth of endothelial cells and reduces the inflammatory
`response to stent mediated vascular injury.
`
`• September 2000, CE mark received
`• December 2000, clinical evaluation at Swiss
`Cardiovascular Center, Bern, Switzerland
`• March 2001, multicenter registry study ‘Moonlight’
`with six European centres
`• March 2001, first live case with lunar coronary stent
`system from Inselspital, Bern, Switzerland, to
`Percutaneous Endovascular Therapeutics Congress,
`Santa Fe, Argentina
`
`Figure 17.1: Expanded unmounted Lunar® coronary stent. Insert shows the
`magnified surface.
`
`Page 13
`
`

`

`Franz R Eberli and Stephan Windecker
`
`Figure 17.2: Balloon mounted Lunar® coronary stent.
`
`(b)
`
`Figure 17.3: (a) Electron microscopy of Lunar® stent, (h) Electron microscopy of
`Lunar stent surface showing the particularly rough suface structure of the iridium
`oxide coated stent. It is assumed that the iridium oxide coated, rough suf ace facilitates
`adhesion and growth of endothelial cells.
`
`Figure 17.4: Schematic cross-sectional drawing highlighting the special construction
`of the Lunar stent. The Niobium core of the stent is covered with the iridium oxide. The
`Niobium alloy is a heavy-metal-free material, with the same mechanical features as
`steel. This corrosion-free clinically proven material has self-healing features. The iridium
`oxide decreases the formation of free oxygen radicals, and thus decreases the
`inflammatory stimulus cfter stent implantation.
`
`142
`
`Page 14
`
`

`

`The Lunar Coronary Stent System
`
`Lunar stent technical specifications
`
`Matenal composition:
`
`Niobium alloy stent body iridium oxide
`coated
`
`Degree of radiopacity (grade):
`
`Superior
`
`Ferromagnetism:
`
`MRI:
`
`Metallic surface area:
`
`Stent design:
`
`Strut design:
`
`Strut dimensions:
`
`Strut angles:
`
`Strut thickness:
`
`Crossing profile(s) on the balloons:
`
`Non-ferromagnetic
`
`MRI-proof
`
`Dependent on expanded diameter
`(13-19%)
`
`Homogeneous, multicellular stent
`structure, 'Starflex' - design
`
`Oval strut cross-section
`
`90 X 85 pm
`
`Dependent on diameter
`
`90 pm
`
`2.5 mm balloon diameter: 0.0382 inch =
`0.96 mm
`4.0 balloon diameter; 0.0471 inch =
`1.20 mm
`
`Longitudinal flexibility:
`
`Percentage shortening (on delivery):
`
`Percentage shortening on expansion:
`
`Expansion range:
`
`Degree of recoil (shape memory):
`
`Radial force:
`
`Good
`
`0%
`
`<3%
`
`2.5-4.5 mm
`
`<3%
`
`High
`
`Currently available diameters:
`
`2.5-4.0 mm
`
`Currently available lengths
`Mounted/implanted
`Unmounted:
`
`Currently available sizes:
`
`8 mm* 12 mm, 16 mm, 20 mm,
`24 mm* 32 mm
`
`Each length for 2.5/3.0/3.5/4.0 mm
`balloon diameter
`
`Recrossability of implanted stent:
`
`Excellent
`
`Other non-coronary types available
`
`Peripheral stents
`Antares Endovascular OTW
`Antares Renal RX
`
`* Planned
`
`143
`
`Page 15
`
`

`

`Franz R Eberli and Stephan Windecker
`
`Figure 17.5: A stenosis in the mid-right coronary artery (a) was treated with the
`Lunar® coronary stent (b). Fluoroscopy reveals the high radiopacity of the Lunar®
`stent (c). At 6 months, follow-up angiography shows an excellent late result with
`minimal restenosis (d).
`
`Figure 17.6:1VUS image of a
`fully deployed Lunar® stent.
`
`144
`
`Page 16
`
`

`

`The Lunar Coronary Stent System
`
`Indications for use
`In patients eligible for balloon angioplasty with symptomatic ischemic
`•
`heart disease characterized by discrete de novo and restenosed coronary
`artery lesions with reference vessel diameter from 2.5 mm to 4.5 mm.
`In elective implantation and in treatment of acute or threatened closure
`associated with a coronary intervention, including saphenous vein grafts.
`
`•
`
`Why I like this stent
`Conceptual considerations: The Lunar® Coronary Stent System consists of a
`Niobium alloy stent body and a layer of homogeneous iridium oxide. The
`Niobium alloy is a heavy-metal-free material, with the same mechanical
`features as steel, but with excellent visibility. This corrosion-free clinically
`proven material has self-healing features.
`The Lunar® coronary stent system special coating consists of a layer of
`ductile gold and a top layer of homogeneous iridium oxide. The gold
`coating assures fissure-free deployment and is also responsible for the
`excellent visibility of the stent. The iridium oxide coating is believed to
`reduce in-stent restenosis by decreasing the inflammatory response to the
`stent via its antioxidant action. A metallic stent induces a leucocyte
`reponse as soon as it is deployed. The leucoytes release hydrogen peroxide
`(H2O2), which stimulates the proliferation of vascular smooth muscle cells
`both directly via the activation of NF-kB, or indirectly via tihe formation of
`peroxynitrite. Iridium oxide has high catalytic properties, and cleaves H2O2
`into water and oxygen. Therefore, the release and activation of free
`radicals, which provoke smooth muscle cell growth, is reduced.
`Experimentally, iridium oxide reduced by 50% free radical formation by
`stimulated leucocytes adherent to stent struts. Iridium oxide layers form a
`rough surface. Experimentally, adhesion of endothelial cells to the rough
`stent surface was markedly increased as compared to a smooth stent
`surface. In summary, the iridium oxide coating may promote endothelial
`coverage of the implanted stent while reducing free oxygen radical
`formation and the inflammatory response, thus reducing smooth muscle
`cell proliferation and in-stent restenosis. This stent property is maintained
`over time. The iridium oxide coating is not degraded. Therefore, the Lunar
`stent is not a drug eluting stent, whose effects are time-dependent.
`
`145
`
`Page 17
`
`

`

`Franz R Eberli and Stephan Windecker
`
`Tips and tricks for delivery
`The low profile of the Lunar stent allows easy delivery through 5 Fr
`guiding catheter systems. The crimping is adequate. The stent delivery
`system is suitable for direct stenting, but extremely tortuous vessels and
`calcification should be avoided.
`
`Ongoing studies
`• Moonlight study: European prospective, multicentre registry of 1 20
`consecutive patients with single or multivessel disease. Follow-up 1 and
`6 months. Started March 2001.
`• Clinical evaluation of the Lunar coronary stent system at the Swiss
`Cardiovascular Center, Bern, Switzerland
`• Clinical evaluation of the Lunar coronary stent system in Argentina and
`Brazil, with 40 patients.
`
`146
`
`Page 18
`
`

`

`32. The Spiral Force Stent
`
`Bolton Medical Inc. Fair Lawn, NJ, USA
`Norman T Kanesaka and Tomas Berrazueta
`
`Definition
`
`The Spiral Force coronary stent is a tubular stent, which
`is cut from 316 L stainless steel and electro-polished. It
`features a unique spiral strut design in which all of the
`struts are connected with inverted C-joints. This spiral
`design provides unsurpassed flexibility, while the
`connection of all struts ensures uniform expansion and a
`high radial force. The stent offers outstanding radial
`force and minimum recoil, because the scaffolding
`design connects all struts together for uniform
`distribution of support.
`
`Introduced in 1999 and distributed worldwide since
`then. The Spiral Force’s unique spiral design provides
`excellent flexibility.
`
`Figure 32.1:
`Electron
`micrograph oj
`Spiral Force
`Stent.
`
`Page 19
`
`

`

`Norman T Kanesaka and Tomas Berrazueta
`
`Figure 32.2: Spiral Force Stent, pre- and post-LAD implantation.
`
`Figure 32.3: Spiral Force Stent, pre- and post-RCA implantation.
`
`Figure 32.4: Spiral Force Stent, pre- and post-LAD implantation.
`
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`

`

`The Spiral Force Stent
`
`Spiral Force stent technical specifications
`
`Material composition:
`
`316 L stainless steel
`
`Degree of radiopacity (grade):
`
`Moderate
`
`Ferromagnetism:
`
`MRI:
`
`Stent design:
`
`Strut design:
`
`Strut dimensions: '
`
`Strut angles:
`
`Strut thickness:
`
`Wire thickness:
`
`Mesh angle:
`
`Mesh braid angle:
`
`Non-Ferromagnetic
`
`MRI Safe
`
`Spiral cut with C-joints
`
`Straight struts
`
`0.005 inch X 0.026 inch to 0.005 inch X
`0,035 inch
`
`40“M5o 4 mm internal diameter
`
`0.003 inch
`
`Not applicable
`
`Not applicable
`
`Not applicable
`
`Profile(s): non-expanded (uncrimped):
`expanded:
`on the balloons:
`
`0.067 inch
`2.7 to 4.2 mm
`0.039 inch to 0.042 inch
`
`Longitudinal flexibility:
`
`Excellent
`
`Percentage shortening on expansion;
`
`3.8—8.2% depending an expansion
`
`Expansion range:
`
`2.5 mm to 4.25 mm
`
`Degree of recoil (shape memory):
`
`1.2%
`
`Radial force:
`
`Very high
`
`Currently available diameters:
`
`2.5, 3.0, 3.5, 4.0 mm
`
`Currently available lengths
`mounted/unmounted:
`
`9, 13, 17, 21 and 27
`
`Other non-coronary types available:
`
`Femoral, iliac, renal in late 2001
`
`Delivery system
`
`The rapid exchange Runner is the latest generation stent delivery balloon
`catheter. The Zylite balloon material (semi-compliant) gives: controlled
`compliance, increased flexibility, optimal refolding and high pressure
`seating.
`The Runner balloon is also designed to be used for standard PTCA
`procedures, such as routine pre-dilatation angioplasty and post-stent
`deployment. It is available in all lengths and diameters.
`
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`Page 21
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`

`

`Norman T Kanesaka and Tomas Berrazueta
`
`Tips and tricks for delivery
`This is a really simple stent to use clue to the adequate radiopacity and
`flexibility. Due to the low compliance of the balloon and the easy stent
`expansion at mid-pressures, it is recommended to slightly oversize the
`stent. It is unusual to observe distal dissections. All sizes of tire Spiral
`Force stent can be easily delivered through all commercially available 6 Fr
`guiding catheters and through a Medtronic Zuma S Fr guiding catheter.
`
`Figure 32.5: Spiral Force premounted on the Runner delivery system.
`
`Figure 32.6: Spiral Force stent.
`
`270
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`

`

`The Spiral Force Stent
`
`Indications for use
`The Spiral Force (SF)™ balloon-expandable stent is indicated for use in de
`novo native coronary artery lesions with a reference vessel diameter in the
`range of 2.5 —4 mm and a length up to 25 mm. In this population, stenting
`produces a larger luminal diameter, maintains arterial patency, and reduces
`the incidence of restenosis at six months as compared with balloon
`angioplasty. One year and longer follow-up is not well characterized.
`
`Why I like my stent
`There are many specifications for stents, but three major factors —
`flexibility, radial force and recoil — play the major roles in short and long
`term performance of the stent. Flexibility can be obtained either by design
`configuration or skipping connections. Higher radial force can be achieved
`from using a thicker material or connecting all struts. Reduced recoil rate
`is a design and material issue. The Spiral Force stent successfully comprises
`all three factors.
`The Spiral Force achieves all three goals with superior engineering
`without compromising other factors nor resorting to the easier solutions.
`
`Studies in which stent is involved
`1) JAPAN:
`Japanese Spiral Force Study - 100 Patients (Finished)
`2) SPAIN + PORTUGAL:
`RESET (Spiral Force Spanish Registry) — 428 Patients (Finished)
`3) BELGIUM:
`SPIFO (Spiral Force Patency, Belgium Study) — 75 Patients (Running)
`4) FRANCE:
`Spiral Force French Registry — 125 Patients (Running)
`
`271
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`Page 23
`
`

`

`33. The Tsunami Coronary Stent
`System
`
`Terumo Corporation, Japan
`Masakiyo Nobuyoshi
`
`Description
`
`• Balloon expandable
`• Stainless steel slotted tube stent
`• Double-linked diamond cell structure
`
`Important features of Tsunami
`• Superb deliverability
`Hydrophilic M coat™ is applied onto the tip and distal shaft of the
`delivery balloon catheter, decreasing friction when moistened. In
`addition to the M coat™, the benefits of the ultra-low profile
`(0.038 inch for 3.0 mm system), the unique double-link connection, the
`smooth stent surface, and the Tri-fold balloon combine to ensure superb
`stent delivery, trackability and crossability.
`• Exceptional conformability
`Terumo’s double-link structure — diamond-shaped cells joined by two
`connectors — results in unequalled stent flexibility. This pliable stent
`gives exceptional conformability to natural tortuosity of coronary
`vessels once deployed.
`• Powerful and stable radial force
`Radial strength and vessel coverage on bends are assured by the stainless
`steel laser-cut tube design and the double-link cell pattern. When
`placed in the lesion, the stent firmly retains its shape and position.
`• Minimum injury and maximum security
`Tsunami’s minimal balloon overhang (< 1 mm) lessens injury during
`dilatation. In addition, tire stent edge design reduces flaring risk
`providing more secure procedure.
`
`Page 24
`
`

`

`Masakiyo Nobuyoshi
`
`Tsunami technical specifications
`
`Material composition:
`
`Degree of radiopacity:
`
`Ferromagnetism:
`
`MRI:
`
`Metallic surtace area expanded:
`
`316 L stainless steel
`
`Moderate
`
`Moderate
`
`Safe
`
`< 18%
`
`Stent design:
`
`Strut design:
`
`Strut thickness:
`
`Ncn-expanded profile:
`
`Longitudinal flexibility:
`
`Percentage shortening:
`
`Degree of recoil:
`
`Current available sizes:
`
`Several radial diamonds joined by double
`connector
`
`Square
`
`0.08 mm
`
`0.95 mm (0.038 inch) for the 3.0 mm
`stent system
`
`Excellent
`
`<5%
`
`<5%
`
`2.5/15, 2.5/20, 2.5/30
`3.0/10, 3.0/15, 3.0/20. 3.0/30
`3.5/10, 3.5/15, 3.5/20. 3.5/30
`4.0/10. 4.0/15. 4.0/20
`
`Other non-coronary types available:
`
`None
`
`Tsunami stent delivery system
`
`Mechanism of deployment;
`
`Balloon expandable
`
`Minimal internal diameter of guiding
`catheter
`
`Pre-mounted on delivery catheter
`
`Protective sheath/covec
`
`0.056 inch, 5 Fr
`
`Yes
`
`No
`
`Position of radiopaque markei's:
`
`Distal and proximal to stent
`
`Recommended deployment pressure:
`
`Nominal at 10 atm (9 atm for 4.0 mm)
`
`Further balloon expansion recommended
`
`Discretionary
`
`Supply in bare
`
`Recrossability of deployed stent
`
`No
`
`Good
`
`Sizing diameter
`
`Equal to artery or over-sizing up to 10%
`
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`
`Page 25
`
`

`

`The Tsunami Coronary Stent System
`
`Figure 33.1: Tsunami — conformability.
`
`Figure 33.2: Tsunami product range (10, 15, 20 and 30 mm lengths).
`
`275
`
`Page 26
`
`

`

`Masakiyo Nobuyoshi
`
`Figure 33.4: Expanded Tsunami stent system.
`
`276
`
`Page 27
`
`

`

`The Tsunami Coronary Stent System
`
`Figure 33.5:
`Expanded Tsunami
`stent.
`
`Figure 33.6: Technical drawing of Tsunami.
`
`277
`
`Page 28
`
`

`

`Masakiyo Nobuyoshi
`
`Indications for use
`• Useful in distal and tortuous vessel
`• Long lesions
`• Acute closure or bail out situations
`• Smaller vessels
`• Acute myocardial infarction
`• De-novo lesions
`• Lesions in bends
`• Vein graft stenosis
`• Sub-optimal PTC A result
`• Moderate calcified lesions
`
`Why I like my stent
`• Superior deliverability assured by very low profile (one of the lowest),
`M coat (Terumo’s hydrophilic polymer on tip and shaft), and flexible
`system (unique double-link connection).
`• Good conformability and high radial force for long-term outcome
`provided by double-linked diamond cells tubular structure.
`• Minimum vessel injury realized by minimal balloon overhang.
`
`Ongoing planned trials
`• Japan trial, Dr Masakiyo Nobuyoshi, Kokura Memorial Hospital, Japan
`• TESTER, Professor Serruys, Thoraxcenter, Rotterdam, The
`Netherlands
`
`Review of the current published literature
`• Nobuyoshi M, Yokoi H, Mitsudo K, Kadota K, Saito S, Hosokawa J.
`Early and late outcomes of Coronary Stent System (TRE-963). J Clin
`Exp Med 1998;75:209-221.
`• Yokoi H, NakagawaY, Tamura T, Hamasaki N, Kimura T, Nosaka H,
`Nobuyoshi M. Preliminary experiences with tire Terumo coronary stent
`[abstract]. J Am Coll Cardiol 1998;31 (suppl):41 3A.
`
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`
`Page 29
`
`

`

`34. The Zebra Stent
`
`Bolton Medical Inc, Fair Lawn, NJ, USA
`Norman T Kanesaka and Tomas Berrazueta
`
`Definition
`
`The Zebra coronary stent is a tubular stent, which is
`laser cut from 316 L stainless steel and electro-polished.
`It has bigger cells on both ends to give a ‘variable
`metal coverage’. The central part features a spiral strut
`design in which all of the stents are connected with
`inverted C joints.
`
`The Zebra was developed in mid-2000 to incorporate all
`the superior features of Bolton Medical’s Spiral Force
`stent — flexibility, high radial force and minimum recoil
`— with reduced metal coverage on the stent ends for
`better transitions to the non-stented areas.
`
`Figure 34.1: Expanded Zebra stent.
`
`Figure 34.2: Scanning
`electron micrograph of the Zebra
`stent.
`
`Page 30
`
`

`

`Norman T Kanesaka and TomAs Berrazueta
`
`Zebra stent technical specifications
`
`Material composition:
`
`316 L stainless steel
`
`Degree of radiopacity (grade):
`
`Moderate
`
`Ferromagnetism:
`
`MRI;
`
`Non-femomagnetic
`
`MRI safe
`
`Metallic surface area expanded:
`
`Approximately I 3% at 3.5 mm
`
`Stent design:
`
`Strut design:
`
`Strut dimensions:
`
`Strut angles:
`
`Strut thickness:
`
`Wire thickness:
`
`Mesh angle:
`
`Mesh braid angle:
`
`Spiral cut with C-joints
`
`Straight struts
`
`0.005 inch x 0.0'26 inch to
`0.007 inch X 0.080 inch
`
`40° to 55° @ 4 mm internal diameter
`
`0.003 inch
`
`Not Applicable
`
`Not applicable
`
`Not applicable
`
`Profile(s): non-expanded (uncrimped):
`expanded:
`on the balloons:
`
`0.067 inch
`2.7 mm to 4.2 mm
`0.039 inch to 0.042 inch
`
`Longitudinal flexibility:
`
`Excellent
`
`Percentage shortening on expansion:
`
`2.5-10.8% depending on expansion
`
`Expansion range:
`
`2.5 mm to 4.25 mm
`
`Degree of recoil (shape memory):
`
`1.2%
`
`Radial force:
`
`Very high
`
`Currently available diameters:
`
`2.5, 3.0. 3.5, 4.0 mm
`
`Currently available lengths
`mounted/implanted:
`unmounted:
`
`See tables
`14 mm, 19 mm
`
`280
`
`Page 31
`
`

`

`The Zebra Stent
`
`Device for delivery
`The rapid exchange Runner is the latest generation stent delivery balloon
`catheter. The Zylite balloon material (semi-compliant) gives: controlled
`compliance, increased flexibility, optimal refolding and high pressure
`seating.
`The Runner balloon is also designed to be used for standard PTC A
`procedures, such as routine pre-dilatation angioplasty and post-stent
`deployment. It is available in all lengths and diameters.
`
`Indications for use
`See Spiral Force chapter.
`
`Why I like my stent
`The Zebra inherits all of the superior, fundamental design patterns of
`Bolton Medical’s Spiral Force in the center of the stent, but the end cells
`are enlarged for reduced metal coverage. This is a very unique design.
`
`Studies in which stent is involved
`1) ZEBRA BELGIUM STUDY
`7 centres
`ISO patients
`Registry
`Will start on June 2001
`
`2) ZEBRA SPAIN STUDY
`S centres
`200 patients
`Registry
`Will start on June 2001
`
`281
`
`Page 32
`
`