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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-01294, U.S. Patent 6,371,962
`Exhibit 2001
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`

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`C) Martin Dunitz Ltd 2000
`
`First published in the United Kingdom in 1997 by J
`Martin Dunitz Ltd
`
`The Livery House
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`Second Edition 1998
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`Reprinted 1998
`Third Edition 2000'
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`Reprinted 2000
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`'34. THE NIR AND NIROYAL
`CORONARY STENTS
`
`MedinoI/SciMed Life Systems, MdPIe Graven/MN, USA
`
`' Kobi Richter, Yaron Almagor and Martin Leon
`
`Description
`___________________.___._.-————————————-
`
`A.
`.
`General
`The NIR Stent was developed based on many physicians’ ‘wish list’ for new
`functional‘ features in order to overcome shortcomings of first generation
`devices. The two most important features of the coronary stent are basic to its
`use: the radial force with which it supports the vessel, and its flexibility, one of l
`the major determinants of its trackability into the target lesion before deploy— .
`ment. The basic contradiction between flexible structure that enable good track—
`ability and rigid structure that result in optimal support, brought the developers
`of first generation stents to select one property while compromising on the
`other. A typical comparison of features resulting from that forced decision is:
`“a
`
`Flexibility
`Radial support
`Stent
`_________,____.___.______...__——————
`
`Low
`High
`Palmaz—Schatz
`. ________________________________
`
`Gianturco—Roubin
`
`Low
`
`High
`
`Our primary goal in designing the NIR Stent was to overcome this compromise
`by a new design for the stent, with a secondary goal to optimize other clinically
`important features.
`
`Transforming geometry.
`A design goal was defined noticing that the two features are not required simul-
`taneously, but rather at two mutually exclusive time slices.
`-' Flexibility is required only during insertion and until deployment of the stent
`at the target lesion.
`' Rigidity is required to supply long term support to the vessel wall only from
`g
`the moment of deployment and on.
`'
`It was thus defined that the desired geometry should be flexiblevupon insertion
`and will change after deployment to be rigid upon expansion.
`'
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`K031 RICHTER, YARON ALMAGOR AND MARTIN LEON
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`‘ F
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`igure 34.1: The NIR stent before expansion, showing the dflerentially
`elongating cells. The cell inside the curve is shorter than its counterpart
`outside the curve, as shown by the converging lines at their border. This
`feature is enabled by the vertical loop component of the cell that opens on
`the outside cell (A) and closes on the inside cell (B).
`
`Trackability and flexibility
`’ The flexibility of a stent, a long stent especially, is a major parameter in deter—
`mining its trackability into the naturally curved and tortuous anatomy of diseased
`coronary arteries. In order to track into such anatomies the stent on its deliv~
`ery system has to curve around corners or it will. latch on the opposing vessel
`wall. The flexibility depends on the ability of the stent to elongate differentially
`such that the stent wall outside of the curve be longer than the wall inside the
`curve. Inability or high resistance to such differential elongation will not allow
`the stent to flex. The design of the NIR stent is based on uniform cells each of
`which is capable of elongating or foreshortening as demonstrated in Figure 34.1.
`Other important features that facilitate the trackability of the stent are;
`
`1. The stent has no ‘free internal points’ loops or ends internal to the tubular
`structure that are not connected longitudinally to their neighbors and thus
`can flare out and generate internal ridges that will latch on plaque surface
`upon insertion (Figure 34.2).
`4
`,
`.
`2. The stent has a very low profile and crirnps easily and securely on the balloon
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`THE NIR AND NIROYAL CORONARY ‘STEN-TS
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`, w
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`owing to the original structure with struts slightly open (see Figure 34.1)
`that leaves a lot of room for crimping until struts touch each other (See Figure
`34.2).
`
`3. Most of the struts are along the insertion direction of the stent and thus. will
`not catch on plaque the way a typical coiled stent would (see Figure 34.2).
`
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`K031 RICHTER, YARON ALMAGOR AND MARTIN LEON
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`igure 34.2: The crimped NIR stent, showing a low profile of less than
`1.0 mm and a smooth surface with no internal'flare—out points at the.
`outside of a curved section. Notice also the difference between the slightly
`open struts of Figure 34.1 and the tightly crimped struts at thisfigure.
`
`:1
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`
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`Figure 34.3: The expanded NIR stent, showing uniform cells in which the
`Vertical loop struts have aligned with the horizontal loop struts to form
`straight struts. The resulting structure is (i very rigid and strong structure.
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`THE NIR AND NIROYAL CORONARY STENTS r
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`Rigidity and radial support
`During expansion of the stent in the target lesion the geometry of the basic
`uniform 'cell changes (Figure 34.3) in a way that will cause the vertical loops of
`the cell to align with the horizontal loops and form a diamond-like cell with
`straight struts at about 45°.
`I
`d
`The resulting diamond—like mesh with interlinked struts is much stronger and
`more rigid than any structure Without such interlinking. At this point in time
`the stent loses its flexibility, but this lost feature is. no longer important since
`the stent is not required to move anywhere.
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`Important features of the expanded NIR stent
`1. The uniform cellular design allows for a continuous supportwithout
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`gaps unlike articulations in other stents, or increased distance between
`struts that may occur in stents whose struts are. not interlinked and
`
`move relative to each other.
`'
`2. The relatively small cells decreased the chance .for tissue prolapse and
`
`plaque scale protrusion. into the lumen. The smaller cells made of
`
`shorter struts provide for higher radial resistance and decreased wall
`
`trauma by decreasing the local pressure on the wall. The number of
`
`circumferential struts in the NIR stent is 18 and in the-Palmaz—Schatzv
`8,"thus at an equal total radial force the local force applied by each strut
`
`is less than one half in the NIR stent.
`
`. 3. The differential elongation of the vertical loops of the cells, responsible
`
`for the flexibility upon insertion, allows for conformance of the stent
`
`‘with the vessel curvature such that the rigid expanded stent does not
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`straighten the vessel and does not create a sharp kink at the interface
`betWeen the stented area and the unstented area. Such a kink created
`by other rigid stents (e.g. Palmaz—Schatz may cause turbulence and
`applies excessive local pressure that accounts for a higher restenosis rate
`at the stent ends. That feature of conformance with vessel curvature (see
`Figure 34.3) allows also for multiple stenting of long segments required
`in many cases of diffuse disease and generates a smooth conformed
`reconstructed section.
`‘
`4-. Most stents available on the market foreshor‘ten upon expansion by
`varied amounts owing to the change in diameter of the stent. The
`combination of vertical
`loops and horizontal loops in the NIR cell
`
`
`results in minimized foreshortening based on the fact that upon expan—‘
`
`
`sion the horizontal loops foreshorten but the vertical loops elongate and
`
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`compensate for the foréshorteping thus keeping the total length of the
`
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`cell unchanged (Figure 34-14).
`‘
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`_ K031 RICHTER, YARON ALMAGOR AND MARTIN LEON '3‘.r
`:‘r
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`'1:
`:5;K
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`Figure 34.4: While the
`cell expands the
`horizontal loops
`foreshorten and the
`vertical loops elongate to
`leave the total length of
`the cell unchanged.
`
`
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`
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`case example
`The following is an example of a case treated with the NIR stent. It is from the
`first pilot study performed in the Centro Cuore in Milan on july 1995, by Drs
`Colombo, Almagor and DiMario. '
`
`'Case 1:
`
`A 32—mm stent was insertecl into a very tortuous RCA using a right Judldns guiding
`catheter. In spite of the suboptimal support the stent tracked into the vessel
`smoothly to yield a good result in a very short procedure involving. a single stent.
`
`Conclusion
`
`The NIR stent is a second generation stem with improved functional features,
`_ as demonstrated by its geometry clinical results.
`
`
`
`Figure 3455': A 32—min NIR stem was inserted into a veg/tortuous RCA,
`demonstrating the trackability of the stem. The result on the right would require at
`least two stents of other designs.
`'
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`THE NIR AND NIROYAL CORONARY STENTS
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`I
`New features available
`Two main new features have been introduced to the coronary market since the
`first edition. A pre—mounted system and the NIROYAL gold plated radio—opaque
`stent. The pre-mounted system, the NIR PRIMOTM, features the NIRTM PRIMOTM '
`stent pre-mounted on a modified VIVA ,PRIMOTM balloon catheter from SciMED.
`The pre—mounted system saves time as crimping is not required and increases
`safety by a better and more consistent crimping. The system also features a short
`ring of plastic material inserted under the balloon in front of the stent. This
`increases the diameter of the balloon in front of the stent and creates a ‘dam’
`that prevents the stent from slipping off the balloon (see Figure 34.6).
`The NIROYAL stent is a NIR stent plated with gold (see Figure 34.7) to
`increase its radio-opacity. The stent has indeed a drastically improved radio—
`opacity (see Figure 34.8) that allows its visualization before and after expansion.
`The radio—opacity “of the NIROYAL was, nevertheless, designed such that the
`stent will be visible but will not hide angiographic details after its deployment
`(see Figures 34.9—34.16). The radio-opacity of the NIROYAL is important for ‘
`positioning judgment by the physician, and especially in cases of multiple stents
`for judgment of overlap, and in bifurcation and ostial stenting where relative
`position is critical.
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`K031 RICHTER, YARON ALMAGOR AND MARTIN LEON
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`Figure 34. 6: The distal tip of the stem premounted on a balloon, showing the
`‘Dam’ (arrows).
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`
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`Figure 34. 7: The NIROK’iL stem-after expansion.
`
`Figure 34.8:
`An X—ray
`radiograph of an
`excised porcine
`heart shows the
`excellent radio-
`
`opaclgl of the
`NIROYAL stems
`
`(yellow arrow), as
`compared to the
`regular NIR stent
`(red arrow).
`
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`THE NIR-AND NIROYAL CORONARY STENTSWM
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`Case example
`V The following is an example of a case treated with new NIR stents. It is a case
`of a bifurcation stenting performed with the NIROYAL.
`
`Case 1:
`A lesion'in the LAD involving an ostial lesion in the first diagonal was selected
`for treatment (Figure 34.9). A 32 mini, long NIROYAL was placed in the LAD
`across the bifurcation of the diagonal (Figures 3410 and 34.11). A second, 9 mm
`long NIROYAL was inserted into the diagonal through the cells of the LAD stent
`(Figures 34.12 and 34.13). The diagonal stent left a gap at .the ostium uncov-
`ered (Figure 34.14) and a third NIROYAL was placed to bridge the gap (Figure
`34.15) to yield a good final result (Figure 34.16).
`--
`-
`‘
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`Figure 34.9: A lesion in the LADYred arrow) overlaps an ostial lesion in
`the diagonal (yellow arrow).
`“
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`v
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`K0131 RICHTER, YARON ALMAGOR AND MARTIN LEONW
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`Figure'34.10: The 32 mm NIROYAL is placed 1'11 the LAD showing its
`radiopacz’tjw
`'
`\
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`Figure 34.11: The NIROYAI. éxpafided in the LAD
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`' Figure 34.12: The short NIROYAL (arrow) is Placea in the diagonal
`"i
`through the struts (3" the expanded stem;
`
`Figure 34.13: The second stent depicyed using 'Izissing balloons'
`technique. '
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`K051 RICHTER, YARON ALMAGOR AND MARTIN LEON
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`Figure 34.14: The two expanded stems show a gap (arrow)_at the ostium
`9f the diagonal.
`'
`'
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`igfire 34.15: Aftei deployment of a third stem (arrow) the bifurcation is
`fully covered.
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`THE NIR AND NIROYAL' CORONARY STENTS _
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`Figure 34.16: Fina] result demonstrating that the NIROYAL does not hide
`angiographic details.
`'
`-
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`References
`
`1. Almagor Y, Feld S‘, Kiemeneij F et al, for the FINESS Trial Investigators. First
`international new intravascular rigid-flex endovascular stent study (FINESS):
`clinical and angiographic results after elective and urgent stent implantation. ] Am
`I
`Coll Cardio] 1997;30:847—54.
`'
`
`Almagor Y, Feld S, Kiemeneij F et al. First international new intravascular rigid-
`flex endovascular stent study: angiographic results and six month clinical follow—
`up. Eur Heart} 1997;18(suppl):156.
`_Di Mario C, Reimers B, Almagor Y et al. Procedural and follow—up results with
`a new balloon expandable stent in unselected lesions. Heart 1998;79:234—41.
`
`Zheng H, Corcos T, Favereau X, Pentousis D, Guérin Y, Ouzan ]. Preliminary
`experience with the NIR coronary stent. Catheter Cardiovasc Diagn
`1998;43:153—58.
`
`V Lau KW, He Q, Ding ZP, Quek S, Johan A. Early experience with the NIR
`intracoronary stent. Am j CardioI 1998;81:927—29.
`
`Chevalier B, Lefevre T, Meyer P et 31. French registry of seven cells NIRstent
`implantation in $2.5 mm coronary arteries [abstract]. Circulation
`1997;96(suppl) 21-274.
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`Lansky A], Popma ]], Mehran R et 31. Late quantitative angiographic results after
`NIR stent use: results From the NIRVANA randomized trial and registries
`[abstract]. j Am C01] Cardiol 1998;31(suupl):80A.
`
`Baim DS. Acute and 307day clinical results of the NIRVANA Trial [abstract].
`Circulation 1997;96(supp1):I-S94.
`
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