20344017
`
`"“i’E‘§§aiS'§”““°‘
`Authors
`Inggfifigylénm.
`Lee TC. Vesely I .
`
`7’r?0y‘/ Mfiflfifi
`H
`I “yhki {J ‘1
`VJ/F/7./~’C'.cx}Cil1~o W
`fl/km..;l'pry
`_'
`C’ 8
`3
`
`-
`
`Department of Biomedical Engineerin , The Lerner Research Institute,
`The Cleveland Clinic Foundation, Ohio, USA.
`Title
`
`'
`
`Biaxial strain properties of elastase-digested porcine aortic valves.
`Source
`
`Journal of Heart Valve Disease.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`
`9(3}:d45-53, 2000 May.
`
`BACKGROUND AND AIMS OF THE STUDY: Previous studies have suggested that
`elastin in porcine aortic valve cusps is responsible for restoring
`collagen fibers to their original configuration between loading-
`unloading cycles. METHODS: Biaxial loading tests were performed on
`intact aortic valves before and after elastase treatment to further
`
`investigate the role of elastin. RESULTS: Degradation of elastin cause;
`
`an increase in the radial dimensions of the cusps {mean increase_in
`gauge length, 29%), which corresponded to a significant decrease in
`radial extensibility [mean decrease,
`61%} and a threefold increase in
`radial stiffness. Changes in circumferential extensibility and stiffness
`were smaller and,
`for most cusps, were not statistically significant.
`Control experiments,
`in which the valves were treated with buffer only,
`resulted in the opposite changes in radial dimensions and extensibility
`(7% decrease in gauge length and doubling of extensibility}. CONCLUSION:
`Changes in the!
`mechanical properties of the aortic valve cusps following incubation in
`elastase were due to elastin damage, and not incidental to soaking in
`buffer. As many explanted bioprosthetic valves have mechanical
`characteristics similar to those of the elastase-treated valves, elastin
`damage may be a factor in the progressive degeneration and ultimate
`failure of bioprosthetic heart valves.
`
`Citation <3>
`
`7%“
`War
`$0“;
`
`Vt
`
`.
`
`-
`
`Sakhaeimanesh AA.
`
`K ‘ID
`,
`
`6
`\
`\.
`’ ,//
`\
`'
`
`24{7j:56d-74, 2000 Jul.
`
`«
`
`”
`
`r
`
`'
`
`62/
`47
`
`We .
`
`Unique Identifier
`20377409
`Pubfled Identifier
`10916068
`Authors
`Morsi YS.
`Institution
`Bio-fluid Dynamics Group, Center for Modeling and Process Analysis,
`School of Engineering and Science, Swinburne University of Technology,
`gawthorn, Victoria, Australia. ymorsi@groupwisewin.edu.au
`itle
`Flow characteristics past jellyfish and St. Vincent valves in the
`aortic position under physiological pulsatile flow co
`itions.
`Source
`Artificial Organs.
`‘
`Loca Messages
`/
`Owned by no I-ISL
`Abstract
`Thrombus formation and hemolysis have been linked to the dynamic flow
`characteristics of heart valve prostheses. To enhance our understandinn
`of the flow characteristics past the a
`ic pos'
`'
`valve in the left ventricle,
`in vitro<§aser Doppler an
`_//
`fl% _
`/ & Medtronic Corevalve, LLC
`flfaw
`v. Troy R. Norred, M.D.
`
`
`
`___...___g-.-uI...___.1.-u...
`
`-
`
`NORRED EXHIBIT 2032 — Page 1
`Medtronic, Inc., Medtronic Vascular, |nc.,
`
`Case|PR2014~00110
`
`

`
`I
`I
`
`‘
`
`,
`
`__.4-...-___
`
`‘
`*
`I
`
`1
`
` 20344017
`
`ut ors
`
`:":§::.:::m=
`Inggigfigygnm.
`Lee TC.
`
` ]
`
`J
`
`l
`
`fr? oy ,/W632
`ff
`lyhnpxx‘
`.
`fl/iv/wrtn W W“ *~*>"*)
`((}{j 8_) 75):) ”};lé)-e) )
`
`vesely I.
`
`Department of Biomedical Engineerin , The Lerner Research Institute,
`The Cleveland Clinic Foundation, Ohio, USA.
`
`'
`
`‘
`
`Biaxial strain properties of elastase-digested porcine aortic valves.
`
`Journal of Heart Valve Disease.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`
`9(3}:d45-53, 2000 May.
`
`BACKGROUND AND AIMS OF THE STUDY: Previous studies have suggested that
`elastin in porcine aortic valve cusps is responsible for restoring
`collagen fibers to their original configuration between loading-
`unloading cycles. METHODS: Biaxial loading tests were performed on
`intact aortic valves before and after elastase treatment to further
`investigate the role of elastin. RESULTS: Degradation of elastin cause
`
`uh
`
`,
`'
`
`0
`
`an increase in the radial dimensions of the cusps (mean increase_in /£3
`: ZIEQ]\
`gauge length, 29%], which corresponded to a significant decrease in
`radial extensibility [mean decrease,
`61%} and a threefold increase in
`‘Ge,
`radial stiffness. Changes in circumferential extensibility and stiffness
`were smaller and,
`for most cusps, were not statistically significant.
`(1)
`.
`Control experiments,
`in which the valves were treated with buffer only,
`resulted in the opposite changes in radial dimensions and extensibility
`(by
`(7% decrease in gauge length and doubling of extensibility). CONCLUSION:
`V?
`Changes in the!
`mechanical properties of the aortic valve cusps following incubation in
`elastase were due to elastin damage, and not incidental to soaking in
`buffer. As many explanted bioprosthetic valves have mechanical
`characteristics similar to those of the elastase-treated valves, elastin
`damage may be a factor in the progressive degeneration and ultimate
`failure of bioprosthetic heart valves.
`
`Citation <3>
`Unique Identifier
`20377409
`
`PubMed Identifier
`
`10916068
`Authors
`
`'
`
`/
`
`\ ‘ID
`
`Sakhaeimanesh AA.
`
`
`
`Morsi YS.
`Institution
`Bio-fluid Dynamics Group, Center for Modeling and Process Analysis,
`School of Engineering and Science, Swinburne University of Technology,
`gawthorn, Victoria, Australia. ymorsi@groupwisewin.edu.au
`itle
`Flow characteristics past jellyfish and St. Vincent valves in the
`aortic position under physiological pulsatile flow co
`itions.
`Source
`L argifiicial Organs.
`24{7I:56d—?4, 2000 Jul.
`"
`‘
`oca
`essages
`/
`Owned by MU HSL
`Abstract
`Thrombus formation and hemolysis have been linked to the dynamic flow
`characteristics of heart valve prostheses. To enhance our understanding
`of the flow characteristics past the a
`ic pos
`'
`fish {JP}
`valve in the left ventricle,
`in vitro
`
`
` aser oppler anemometry
`
`NORRED EXHIBIT 2032 — Page 1
`
`E3;E3;
`
`Is.
`
`'
`
`é2/
`5,1,7
`
`3
`
`_
`
`'
`'
`.
`
`k
`
`

`
`//I
`
`77m //w/we f
`
`119(4 Pt 1}:?53-63,
`
`Grande-Allen KJ. Cochran RP. Reinhall PG. Kunzelman KS.
`Institution
`Department of Biomedical Engineering. Cleveland Clinic Foundation.
`Cleveland. OH, USA.
`Title
`Re—creation of sinuses is important for sparing the aortic valve: a
`finite element study.
`Source
`Journal of Thoracic & Cardiovascular Surgery.
`2000 Apr.
`Local Messages
`Owned by MU HSL
`Abstract
`OBJECTIVE: The treatment of choice for aortic valve insufficiency due
`to root dilatation has become root replacement with aortic valve
`sparing. However, root replacement with a synthetic graft may result in
`altered valve stresses. The purpose of this study was to compare the
`stress/strain patterns in the spared aortic valve in different root
`replacement procedures by means of finite element modeling. METHODS: Our
`finite element model of the normal human root and valve was modified to
`simulate and evaluate three surgical techniques:
`(1) "cylindrical" graft
`sutured below the valve at the anulus,
`(2) "tailored" graft sutured just
`above the valve, and {3} "pseudosinus“ graft,
`tailored and sutured below
`the valve at the anulus. Simulated diastolic pressures were applied, and
`stresses and strains were calculated for the valve, root, and graft.
`Leaflet coaptation was also quantified. RESULTS: All three root
`replacement models demonstrated significantly altered leaflet stress
`patter!
`ns as compared with normal patterns. The cylindrical model showed the
`greatest increases in stress (16%—l?3%} and strain {l0%—98%J,
`followed
`by the tailored model [stress +10%-157%, strain +9!-36%}. The
`pseudosinus model showed the smallest increase in stress [9%—28%) and
`'
`strain (2%-31%), and leaflet coaptation was closest to normal.
`space fo
`ation (tailored, pseudosinus) result in simulated leaflet
`4§EHCLfl§:g§) Valve—sparing techniques that allow the potential for sinus
`stresses that are closer to normal than the cylindrical technique.
`Normalized leaflet stresses in the clinical setting may result in
`improved longevity of the spared valve.
`
`,
`
`”
`
`J}
`
`P
`Eiaw
`
`’zg
`
`Citation <9)
`
`PubMed Identifier
`
`'-
`
`/W”///95%
`
`Auth
`
`Institution
`
`”“§‘é“£$5§$3“““°‘
`10703772
`CC/I
`Caggiola G. Peters GW. Schreurs PJ.
`Department of Mechanical Engineering, Eindhoven University of
`Technology. P.0. Box 513, 5600 MB Eindhoven, The Netherlands.
`giovanna@wfw.wtb.tue.nl
`Title
`A three-dimensional mechanical analysis of a stentless fibre-
`reinforced aortic valve prosthesis.
`Source
`Journal of Biomechanics.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`
`//
`
`I
`
`I7.
`V...
`
`LQZ//V
`Q
`
`%
`
`2
`
`NORRED EXHIBIT 2032 — Page 2
`
`33(5}:521-30, 2000 May.
`
`Abstract
`Failure of bioprosthetic and synthetic three-leaflet valves has been
`shown to occur as a consequence of high tensile and bending stresses,
`
`
`

`
`
`
`r
`
`7//33 2/ 4%/.
`
`in the
`Moreover,
`acting on the leaflets during opening and closi
`stented prostheses, whether synthetic or biological,
`the absence of
`ontraction of the aortic base, due to the rigid stent, ca
`, which
`ea ets to be subjected o
`n un hysiolog ca
`en ,
`is re
`o ca c
`ica ion. It is s own
`'
`'
`ex
`r ic base and leaflet attachment, and leaflet
`fibre-reinforcement result in reduced stresses in the weaker parts of
`the leaflets in their closed configuration. It is postulated that this
`leads to a decrease of tears and perforations, which may result in a
`improved long-term behaviour. The effect of a flexible leaflet
`attachment and aortic base of a synthetic valve is investigated with a
`finite element model. Different fibre-reinforced structures are analysed
`with respect to!
`the stresses that are likely to contribute to the failure of fibre-
`reinforced prostheses and compared with the results obtained for a
`stented prosthesis. Results show that for the stentless models a
`reduction of stresses up to 75% is obtained with respect to stented
`models with the same type of reinforcement.
`
`
`
`Citation <10)
`Unique Identifier
`20140328
`PubMed Identifier
`106?7l58
`Authors
`
`Morsi YS.
`Sakhaeimanesh A. Clayton BR.
`-
`Institution
`Centre for Research and Technology Development, School of Engineering
`and Science, Swinburne University of Technology, Hawthorn, Victoria,
`Australia. ymorsi@swin.edu.au
`Title
`
`C:
`‘)
`QM,
`
`Hydrodynamic evaluation of three artificial aortic valve chambers.
`Source
`
`Artificial Organs.
`Local Messages
`Owned by MU HSL
`Abstract
`
`24(1):57—63, 2000 Jan.
`
`The effect of chamber geometry on the characteristics of turbulent
`steady flow through a newly designed artificial heart valve, "the
`jellyfish valve," has been investigated for flow rates matching those of
`peak systole. Laser Doppler Anemometry {LDA} was employed to determine
`the velocity and shear stress distributions at various locations
`downstream of the jellyfish valve. Three geometrically different aortic
`valve chambers have been investigated: namely,
`a chamber with sinuses of
`valsalva, an ellipsoidal chamber, and a cylindrical chamber. The results
`of this investigation indicated that the aorta with sinuses of Valsalva
`model had the highest turbulent shear stresses whereas the ellipsoidal
`model gave the highest-pressure drops. However,
`for the various flow
`rates examined,
`including the systole peak value of 26 L/min, it appears
`that the ellipsoidal model displays better hydrodynamic characteristics
`in terms of shear stress and uniformity of axial velocity distributions
`
`downstream of the jellyfish valve.
`
`Pubmed Identifier
`10509186
`
`fl
`
`I}
`
`*
`
`'
`
`.
`
`.5-1-1.?-L
`
`‘
`
`i
`4
`1
`
`1
`
`I
`
`
`
`NORRED EXHIBIT 2032 — Page 3
`
`

`
`
`
`
`
`77c? x M M4
`
`Chen CN.
`
`Liang HC.
`
`Sung HW. Chang Y. Chiu CT.
`Institution
`
`Department of Chemical Engineering, National Central University.
`Chung-Li, Taiwan, ROC. hwsung@cc.ncu.edu.tw
`Title
`
`Mechanical properties of a porcine aortic valve fixed with a naturally
`occurring crosslinking agent.
`Source
`
`Biomaterials.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`
`20{19}:1759—72, 1999 Oct.
`
`ic
`'
`f
`The study investigates the mechanical properties
`valve leaflets fixed with a naturally occurrin crosslinking agent,
`
`at distinct pressure heads. Fresh and Eed
`
`the changes
`to fixation,
`coun'- -arts were used as controls. Subsequent
`in leaflet collagen crimps and its surface morphology were investigated
`by light microscopy and scanning electron microscoPY {SEM}. Also,
`the
`crosslinking characteristics of each studied group were determined by
`measuring its fixation index and denaturation temperature.
`In the
`mechanical testing,
`tissue strips made from each studied group were
`examined in both the circumferential and radial directions. Histological
`and SEM comparisons between fresh porcine aortic valve leaflet and those
`fixed at medium or high pressure revealed that the following changes may
`occur: elimination of the natural collagen crimping, and extensive loss
`of the endothelial layer. The denaturation temperatures of the
`glutaralde!
`hyde-fixed leaflets were significantly greater than the genipin-fixed
`leaflets: however,
`their fixation indices were comparable. Generally,
`fixation pressure did not affect the crosslinking characteristics of the
`genipin- and glutaraldehyde-fixed leaflets. It was found that fixation
`of porcine aortic valves in genipin or glutaraldehyde did not alter the
`mechanical anisotropy observed in fresh valve leaflets. This indicated
`that the intramolecular and intermolecular crosslinks introduced into
`the collagen fibrils during fixation is of secondary importance to the
`presence of structural and mechanical anisotropy in fresh leaflet.
`Tissue
`ixa ion in genipi
`a
`e y e may pro uce distinct
`crosslinking structures. However,
`the difference in crosslinking
`structure between the genipin- and glutaraldehyde-fixed leaflets did not
`seem to cause any significant discrepancies in their mechanical
`properties when compared at the same fixation pressure. Nevertheless,
`regardless of the E
`crosslinking agent used, changes in mechanical properties and ruptured
`patterns were observed when the valve leaflets were fixed at distinct
`pressures.
`
`Si§3§i°'£d2iEia.,
`
`//éfl 79 C / a //
`
`LaBorde DV. Yoganathan AP.
`
`__
`
`'
`
`/_
`(:
`_ H
`
`’
`I’ ‘-//
`R
`
`99396317
`Pubfled Identifier
`10463241
`Authors
`Weston MW.
`Institution
`Institute of Bioengineering and Bioscience, School of Biomedical,
`
`Engineering, Georgia Institute of Technology Atlanta 30332-0535, USA.
`T.
`the surface of an aortic valve
`
`leaflet.
`£'§:wga/fc!t-/
`/7,‘)/I‘
`7
`"
`33/
`5L/727:1!/5 as
`"
`7 (4,!)
`:2; 71...:
`//
`
`,_,
`
`_
`
`aw-5:
`
`_,
`7
`
`,
`.
`V
`=72»/—.//tj_j
`
`NORRED EXHIBIT 2032 — Page 4
`
`4.___....__a-
`
`\
`
`

`
`
`
`Authors
`
`Sung HW.
`Institution
`
`
`
`Chang Y.
`
`Chiu CT.
`
`7z:z9 )/ W/a /’/”6’a/
`
`Chen CN.
`
`Liang HC.
`
`Department of Chemical Engineering, National Central University,
`Chung-Li, Taiwan, RDC. hwsung@cc.ncu.edu.tw
`Title
`
`Mechanical properties of a porcine aortic valve fixed with a nature 1
`occurring crosslinking agent.
`Source
`
`L
`
`Bidmaterials.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`
`.20 (19; :1759_-72. 1999. Oct.
`
`'
`
`L
`
`ic
`‘
`The study investigates the mechanical properties
`valve leaflets fixed with a naturally occurrin crosslinkin agent,
`
`at distinct pressure heads. Fresh and ed
`
`coun'~ -
`
`the changes
`to fixation,
`arts were used as controls. Subsequent
`in leaflet collagen crimps and its surface morphology were investigated
`by light microscopy and scanning electron microscopy (SEM}. Also,
`the
`crosslinking characteristics of each studied group were determined by
`measuring its fixation index and denaturation temperature.
`In the
`mechanical testing,
`tissue strips made from each studied group were
`examined in both the circumferential and radial directions. Histological
`and SEM comparisons between fresh porcine aortic valve leaflet and those
`fixed at medium or high pressure revealed that the following changes may
`occur: elimination of the natural collagen crimping, and extensive loss
`of the endothelial layer. The denaturation temperatures of the
`glutaralde!
`hyde-fixed leaflets were significantly greater than the genipin-fixed
`leaflets; however,
`their fixation indices were comparable. Generally,
`fixation pressure did not affect the crosslinking characteristics of the
`genipin- and glutaraldehyde—fixed leaflets. It was found that fixation
`of porcine aortic valves in genipin or glutaraldehyde did not alter the
`mechanical anisotropy observed in fresh valve leaflets. This indicated
`that the intramolecular and intermolecular crosslinks introduced into
`the collagen fibrils during fixation is of secondary importance to the
`pregence of structural and mechanical anisotropy in fresh leaflet.
`Tissue
`ixa ion in genipi
`a
`e y e may pro uce distinct
`crosslinking structures. However,
`the difference in crosslinking
`structure between the genipin- and glutaraldehyde—fixed leaflets did not
`seem to cause any significant discrepancies in their mechanical
`properties when compared at the same fixation pressure. Nevertheless,
`regardless of the I
`crosslinking agent used, changes in mechanical properties and ruptured
`patterns were observed when the valve leaflets were fixed at distinct
`pressures.
`
`//éwzflc
`
`‘7//
`
`Citation <12>
`Unique Identifier
`99396317
`PubMed Identifier
`10468241
`Authors
`Heston MW.
`Institution
`Institute of Bioengineering and Bioscience, School of Biomedical,
`$“9ineering, Georgia Institute of Technology Atlanta 30332-0535, USA.
`
`"on o
`t e s ear stress -
`the surface of an aortic valve
`leaflet.
`_
`
`4...-
`
`LaBorde DV. Yoganathan AP.
`
`NORRED EXHIBIT 2032 — Page 5
`
`

`
`nu”
`
`7//‘c9}/
`
`/04/*Ma/
`
`26251 and Ionescu-Shiley standard pericardial valves were designed prior
`to 1975, while the Medtronic-Hall tilting disc. St. Jude Medical
`bileaflet, Hancock porcine (model 2501, Hancock II porcine {model 410],
`Carpentier—Edwards porcine (model 2650] and Carpentier-Edwards
`pericardial {model 2900} valves were designed after 1975. The pressure
`dro!
`
`performance indices of 0.30 to 0.45, whereas the valves designed after
`1975 had performance indices of 0.40 to 0.?0. The regurgitant volumes
`were higher for the mechanical designs (5.0 to 11.0 cm3/beat} Compared
`to the tissue bioprostheses (1.0 to 5.0 cm3/beat}. Two-dimensional laser
`Doppler anemometry studies indicated that the valves designed after l975
`tended to create more centralized flow fields, with reduced levels of
`turbulent shear stresses. However, none of the current valve designs is
`ideal:
`they all create areas of stasis and/or regions of low velocity
`reverse flow; and regions of elevated turbulent shear stresses that are
`capable of causing sub-lethal and/or lethal damage to the formed
`elements of blood.
`
`Citation <63>
`Unique Identifier
`88243853
`PubMed Identifier
`2967827
`Authors
`
`_
`
`”
`
`R5‘\
`
`Hasenkam JM. Westphal D. Nygaard H. Raul H. Giersiepen M.
`Stodkilde-Jorgensen H.
`Institution
`Department of Thoracic and Cardiovascular Surgery, Aarhus
`Kommunehospital, Denmark.
`Title
`
`'
`\4/)
`
`J
`
`In vitro stress measurements in the vicinity of six mechanical aortic
`valves using hot-film enemometry in steady flow.
`Source
`
`Journal of Biomechanios.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`
`21(3):235-47, 1988.
`
`Based on hot-film anemometry, point velocity measurements in the total
`cross sectional area 1 and 2 diameters downstream of: Bjcrk-Shiley
`Standard, Convex-Concave and Monostrut, Hall-Kaster
`(Medtronic-Hall),
`St. Jude Medical and Starr-Edwards Silastic Ball aortic valves were
`made. The spatial distribution of Reynolds Normal Stresses {RNS} was
`visualized three—dimensionally in order to point out where and to what
`extent the highest RN85 were found. The measurements were made in steady
`flowing glycerol mixture at flow rates 10, 20 and 30 l. min-1
`corresponding to mean velocities of 27, 54 and 81 cm s-1. The highest
`maximum RNS values were around 250 Nm-2 and were found downstream of the
`Bjork-Shiley Monostrut and starr—Edwards Ball valves. The lowest maximum
`RN35 were found downstream of the St. Jude Medical and Hall—Kaster
`(Medtronic-Hall) valves [125-140 Nm-2). The Starr—Edwards valve had the
`highest mean ENS {I17 Nm-2)
`followed by the Bjork-Shiley Monostrut
`(B7
`Nm-2}. These!
`simplified measurements of artificial heart valve performances
`concerning RNS, enhance the interpretation of results in more
`complicated flow models not to say in vivo.
`
`Citation <64>
`
`/7% / /W.
`
`¢3~/
`
`
`
`NORRED EXHIBIT 2032 — Page 6
`
`

`
`f:
`
`0/ fl/pg /'/‘40,/
`
`Leeds polyurethane trileaflet heart valve in a simula ed pulsatile flow
`regime using laser Doppler velocimetry. The main difference between the
`two valves studied was the manufacturing method used to create the
`valves. The film-fabricated valve was constructed from solvent-cast
`sheets of polyurethane,
`thermally formed into the correct leaflet
`geometry. The dip-cast valve used a stainless steel mould which was
`dipped into a polyurethane solution to produce the valve leaflets.
`Significant differences were visible between the fully open leaflet
`shape of each valve. The distribution of mean axial velocity and
`Reynolds normal stress {RN51 was shown to be dependent on the shape of
`the fully open valve orifice. For the film-fabricated valves,
`flow
`recirculation and high values of RNS were present downstream of the
`frame posts. The maximum value of RNS obtained downstream of the film-
`fabricated valve at peak syst!
`ole was 14? N/m2. Results for the dip-cast valve showed a more uniform
`distribution of mean axial velocity and RNS resulting from the more
`circular central orifice produced by the dip—cast leaflets. The maximum
`value of ENS obtained downstream of the dip-cast valve at peak systole
`was 109 N/m2. These results demonstrate the effect of the open valve
`geometry on the flow characteristics downstream of trileaflet valves and
`that minor changes to the open leaflet geometry can significantly affect
`the flow characteristics and the possibility of flow-related blood
`damage occurring in vivo.
`
`Citation <23:
`Unggviifiléglgntifier
`
`PubMed Identifier
`3953434
`Authors
`
`Hasenkam JM. Nygaard H. Terp K. Riis C. Paulsen PK.
`Institution
`
`/fl //
`.
`
`""'/
`
`Aarhus University Hospital, Denmark.
`Title
`
`Hemodynamic evaluation of a new bileaflet valve prosthesis: a
`animal experimental study.
`[see comments].
`
`I
`
`Department of Cardiothoracic and Vascular Surgery, Skejby Sygehus,
`Comment in: J Heart Valve Dis. 1996 Nov;5(6):5?2-3
`Comments
`\\\\ E4)
`
`Source
`
`Journal of Heart Valve Disease.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`
`5(6}:5?4-80, 1996 Nov.
`
`-
`
`\kj//
`
`BACKGROUND AND AIMS OF THE STUDY: A newly developed heart valve
`(Hedtronic Parallel} was tested in an acute animal experimental model.
`METHODS: Five prototype valves were implanted in the aortic position in
`seven 90 kg pigs to enable acute evaluation of the hemodynamic
`performance in terms of turbulent stresses and transvalvular pressure
`drop. Turbulent stresses in the ascending aorta were measured using a 10
`MHZ perivascular Doppler echocardiographic transducer designed to
`measure the radical velocity component at 17 different points covering
`the aortic cross-sectional area. RESULTS: The drop in transvalvular peak
`pressure measured with fluid—filled catheters showed a non-linear
`
`relationship with cardiac output and was always < 12 mmHg. The Reynolds
`normal stresses were < 60 N/m2 in systole within 50 ms
`time windows,
`which is insufficient to cause mechanical damage of the formed elements
`of the blood. CONCLUSIONS: From a hemodynamic point of view the
`performance of the Medt!
`
`ronic Parallel aortic valve is fully acceptable and within the range of
`
`NORRED EXHIBIT 2032 — Page 7
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`

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`humans.
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`inf.
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`7(2]:180-9, 1998 Mar.
`
`Journal of Heart Valve Disease.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`BACKGROUND AND AIMS OF THE STUDY: Pericarbon is a new—generation
`bovine pericardial bioprosthesis designed to withstand mechanical wear.
`Following optimal
`in vitro testing and animal experiments, clinical
`trials were initiated in many European centers and explants sent to our
`department for pathological evaluation. This included gross,
`radiographic, histologic and ultrastructural investigations. METHODS:
`Between 1986 and 1996, 24 bioprostheses (eight aortic,
`ll mitral,
`two
`mitro-aortic, one tricuspid} were collected from 22 patients [10 males
`and 12 females; mean age 57.0 +/— 18.9 years} either at autopsy (nine)
`or reoperation I15}. RESULTS: Ten bioprostheses explanted < 2 months
`after surgery were either normal or failed because of surgical problems
`or non—structural causes. Among the other 14 bioprostheses {mean
`placement 41.9 +/- 23.6 months; range:
`?
`to 90 months}, structural
`deterioration occurred in seven and was due to dystrophic calcification
`with stenosis in five (t!
`hree aortic,
`two mitral}, mixed lesion in one (mitrall, and incompetence
`in one by calcium-related commissural tear tmitral). At
`the
`ultrastructural level, calcification was detected either on cell debris
`or upon collagen fibers. No bioprosthesis failed because of fibrous
`tissue overgrowth. Of the remaining seven bioprostheses, vegetative
`endocarditis occurred in two,
`thrombosis in one, and aseptic
`paravalvular leak in one: whereas three showed no signs of dysfunction.
`CONCLUSIONS: This pathologic experience with the Pericarbon valve showed
`calcification to be the main cause of late structural failure, causing
`mainly cusp stiffness and bioprosthesis stenosis. Tissue rupture or
`abrupt dysfunction never occurred. Thus, prevention of mineralization
`remains the main challenge.
`
`Citation <25>
`
`9450254
`
`\/
`
`,-r-=
`._____)
`
`_
`
`Di Martino E.
`
`Gamba A.
`
`Procopio AM.
`
`Fumero R.
`
`ER‘?
`
`‘£43
`
`\
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`3
`A;
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`C1%{;
`
`Unique Identifier
`98111924
`Pubfled Identifier
`Authors
`Redaelli A.
`Institution
`Department of Bioengineering, Politecnico di Milano, Italy. Gk)
`redaelli@cebitec.hsr.it
`Title
`Assessment of the influence of the compliant aortic root on aortic
`Medical Engineering 5 Physics.
`l9(B}:696-710, 199? Dec.
`
`valve mechanics by means of a geometrical model.
`Source
`
`Abstract
`
`In recent years several researchers have suggested that the changes in
`the geometry and angular dimensions of the aortic root which occur
`during the cardiac cycle are functional to the optimisation of aortic
`valve function, both in terms of diminishing leaflet stresses and of
`
`fluid-dynamic behaviour. The paper presents an analytical parametric
`model of the aortic valve which includes the aortic root movement. The S;
`indexes used to evaluate the valve behaviour are the circumferential
`membrane stress and the stress at the free edge of the leaflet,
`the
`index of bending strain,
`the bending of the leaflet at the line
`attachment in the radial and circumferential directions and the shape of
`
`£7?
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`Lit
`
`NORRED EXHIBIT 2032 — Page 8
`
`
`

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`// /7 @/ Mnxay
`
`98364269
`PubMed Identifier
`9699113
`Authors
`Kolev N.
`Title
`
`Left ventricular end-systolic wall stress and left ventricular
`ejection time revisited. [letter; comment}.
`Comments
`
`Comment on: Eur J Anaesthesiol. 1997 Nov;l4[6J:55B—65
`Source
`European Journal of Anaesthesiology.
`Local Messages
`Owned by MU HSL
`
`15{4}:509-11. 1998 Jul.
`
`Citation <20>
`
`Unique Identifier
`
`99281690
`PubMed Identifier
`10355559
`Authors
`Maymir JC. Deutsch S. Meyer RS. Geselowitz UH. Tarbell JM.
`Institution
`The Bioengineering Program, The Pennsylvania State University,
`University Park, USA.
`Title
`Mean velocity and Reynolds stress measurements in the regurgitant jets
`of tilting disk heart valves in an artificial heart environment.
`Source
`
`(H///’
`
`Annals of Biomedical Engineering.
`Local Messages
`MU HSL owns some issues. Check Library Catalog Holdings.
`Abstract
`Laser Doppler velocimetry, with a high temporal resolution (1 ms time
`windows), was used to measure the flow field in two regions {major and
`minor orifices] near the aortic and mitral valves (Bjork Shiley
`monostrut Nos. 25 and 27, respectively) of the Penn State artificial
`
`26(1}:146—56, 1998 Jan—Feb.
`
`Maximum Reynolds shear stresses of approximately 20,000 dyn/cm2 and
`time-averaged Reynolds shear stresses of approximately 2000 dyn/cm2 were
`observed during the regurgitant flow phase. These elevated Reynolds
`shear stresses suggest that regurgitant jets play a role in the
`
`1
`
`,
`
`I
`
`I
`
`n
`
`Citation <21>
`Unique Identifier
`98394326
`PubMed Identifier
`9727343
`Authors
`Krafczyk M. Cerrolaza M.
`Institution
`Lehrstuhl fur Bauinformatik, Civil Engineering Department, Munich.
`Germany. kraft@server.inf.bauwesen.tu-muenchen.de
`
`Schulz M. Rank E.
`
`Title/;%d7éfl€d/0%
`
`/7‘///
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`NORRED EXHIBIT 2032 — Page 9
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