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

`

`© Martin Dunitz Ltd 2000
`
`First published in the United Kingdom in 1997 by *
`Martin Dunitz Ltd
`The Livery House
`7-9 Pratt Street
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`Second Edition 1998
`Reprinted 1998
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`ISBN 1 85317 802 - 0
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`34. THE NIR AND NIROYAL
`CORONARY STENTS
`Medinol/SciMed Life Systems, Maple Grove,MN, USA
`
`- Kobi Richter, Yaron Almagor and Martin Leon
`
`Description
`
`_Lt
`
`.
`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 importantfeatures of the coronary stent are basic to its
`use: the radial force with which it supports the vessel, andits flexibility, one of
`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:
`
`
`Radial supportStent FlexibilityMe
`
`HighPalmaz—Schatz Lowee
`
`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 otherclinically
`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 timeslices.
`* 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
`the moment of deployment and on.
`,
`It was thus defined that the desired geometry should be flexible upon insertion
`and will change after deployment to be rigid upon expansion.
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`Kost RICHTER, YARON ALMAGOR AND MARTIN LEON
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`‘
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`Figure 34.1: The NIR stent before expansion, showing the differentially
`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
`_ Theflexibility of a stent, a long stent especially, is a major parameter in deter-
`miningits trackability into the naturally curved and tortuous anatomyof diseased
`coronary arteries. In order to track into such anatomies the stent on its deliv-
`ery system has to curve around cornersor 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 importantfeatures 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).
`2. The stent has a verylow profile and crimps easily and securely on the balloon
`
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`
`
`THE NIR AND NIROYAL Coronary STENTS .
`
`a“
`
`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 andthuswill .
`not catch on plaque the way a typical coiled stent would (see Figure 34.2).
`
`4‘5
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`Kosi RICHTER, YARON ALMAGOR AND MarTIN LEON ‘
`
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`Figure 34.2: The crimped NIR stent, showing a low profile ofless 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.
`
`Figure 34.3: The expanded NIR stent, showing uniform cells in which the
`vertical loop struts have aligned with the horizontal loop struts toform
`straight struts. The resulting structure is a very rigid and strong structure.
`
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`THE NIR anp NIROYAL Coronary STENTS «
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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°.
`,
`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
`
`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—Schatz
`8,thus at an equal total radial force the local force applied by each strut
`
`is less than one half in the NIRstent.
`
`3. The differential elongation of the vertical loops of the cells, responsible
`
`for thé flexibility upon insertion, allows for conformance of the stent
`
`‘with thevessel curvature such that the rigid expanded stent does not
`
`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) allowsalso for multiple stenting of long segments required
`
`in many cases of diffuse disease and generates a smooth conformed
`reconstructed section.
`.
`4. Moststents available on the market foreshorten 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
`
`
`compensate for the foreshortening thus keeping the total length of the
`
`cell unchanged (Figure 34,4).
`oO
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`_ Koei RicuTer, YARON ALMAGOR AND MarTIN LEON
`x
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`Figure 34.4: While the
`cell expands the
`horizontal loops
`joreshorten and the
`vertical loops elongate to
`leave the total length of
`
`the cell unchanged.
`
`Case example
`The following is an exampleof a case treated with the NIRstent.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 stentwasinserted into a very tortuous RCA using a right Judkins 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 stent with improved functional features,
`_as demonstrated by its geometryclinical results,
`
`
`
`Figure 34.5: A 32-mm NIR stent was inserted into a very tortuous RCA,
`demonstrating the trackability of the stent. 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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`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 PRIMO™,features the NIR™ PRIMO™ °
`stent pre-mounted on a modified VIVA PRIMO™ 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 NIROYALstent 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 allowsitsvisualization 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 NIROYALis important for ©
`positioning judgment by the physician, and especially in cases of multiple stents
`for judgment of overlap, and in bifarcation and ostial stenting whererelative
`position is critical.
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`Figure 34.6: The distal tip of the stent premounted on a balloon, showing the
`‘Dam’ (arrows).
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`Kost RICHTER, YARON ALMAGOR AND MarTIN LEON
`
`
`
`Figure 34.8:
`An X-ray
`radiograph of an
`excised porcine
`heart shows the
`excellent radio-
`opacity of the
`NIROYAL stents
`(yellow arrow), as
`compared to the
`regular NIR stent
`(red arrow).
`
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`THE NIR AND NIROYAL Coronary STENTS
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`eeeeenenetepennieseenORCCCREECLOACAAALEAOCCALLECOCAADACOLCDACOCORALLDCOAOCCLOCALOCCA
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`Case example
`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 lesionin the LAD involving an ostial lesion in the first diagonal was selected
`for treatment (Figure 34.9). A 32 mm, long NIROYAL was placed in the LAD
`across the bifurcation of the diagonal (Figures 34.10 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 wasplaced to bridge the gap (Figure
`34.15) to yield a goodfinal result (Figure 34. 16).
`oO
`
`
`
`Figure 34.9: A lesion in the LAD(red arrow) overlaps an ostial lesion in
`the diagonal (yellow arrow).
`
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`Kosi RICHTER, YARON ALMAGOR AND MARTIN LEONseeeeenrovetanneaemasnnacammencrmrmmeTottennntAttnRAPAALTCeeCOTOLTIESICCOLOLLIDOLECTCLCCTAO
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`Figure 34,10: The 32 mm NIROYAL is placed in the LAD showing its
`radiopacity.
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`Figure 34.11: The NIROYAL expanded in the LAD
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`- Figure 34,12: The short NIROYAL (arrow) is placed in the diagonal
`
`through the struts of the expanded stent.’
`
`Figure 34, 13: The second stent is
`technique.
`
`deployed using ‘kissing balloons’
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`Kosi RICHTER, YARON ALMAGOR AND MarTIN LEON
`Y
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`Figure 34.14: The two expanded stents show a gap (arrow) at the ostium
`of the diagonal.
`,
`.
`u
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`|
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`Figure 34,15: After deployment ofa third stent (arrow) the bifurcation is
`july covered.
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`Tue NIR AnD NIROYAL CORONARY STENTS |
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`Figure 34,16: Final result demonstrating that the NIROYAL does not hide
`angiographic details.
`
`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. J Am
`Coll Cardiol 1997,30:847—54.
`,
`2; 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 J 1997;18(suppl):156.
`3. Di Mario C, Reimers B, AlmagorY 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 J. Preliminary
`experience with the NIR coronary stent. Catheter Cardiovasc Diagn
`1998;43:153-58.
`5. Lau KW,HeQ,Ding ZP, Quek S, Johan A. Early experience with the NIR
`intracoronary stent. Am J Cardiol 1998;81:927-29.
`. 6 Chevalier B, Lefevre T, Meyer P et al. French registry of seven cells NIRstent
`implantation in S2.5 mm coronaryarteries [abstract]. Circulation
`1997;96(suppl) :1-274.
`
`4.
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`Lansky AJ, Popma JJ, MehranRet al. Late quantitative angiographic results after
`NIRstent use: results from the NIRVANA randomizedtrial and registries
`[abstract]. J Am Coll Cardiol 1998;31(suupl):80A.
`
`
`
`Baim DS. Acute and 30-day clinical results of the NIRVANA Trial [abstract].
`Circulation 1997;96(suppl):1-594.
`
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