NORRED EXHIBIT 2253 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00395
`
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`PERCUTANEOUS AORTIC p
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`The aortic valve undergoes a series of changes based upon the
`structure at birth and the dynamic stresses, which“-it+has-to~undergo~~daily.
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`The trileaflet aortic valve will not become stenotic usually until the 7”‘
`decade unless infectious processes are introduced sooner. The incidence of
`aortic stenosis can reach between 2 to 9 % in this age range. The average
`moitality rate at all ages is 9% /year which also increases as a population
`ages. Coupled with these facts is the likelihood that as a person ages and
`becomes symptomatic with aortic stenosis, he is less likely to be an
`operative candidate. The mortality of octogenarians has been reported as
`high as 20% for aortic valve replacement that can preclude a reasonable
`attempt at the therapy of choice, which is surgical replacement.
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`i In an attempt to formulate an effective therapy for this class of patients, I
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`minimize thegfiishl to the patient cl” ring the procedure. This procedure
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`The first in ailine ofoptions involves the placement ofan aortic valve
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`eliminates the need for bypass pump or sternotomy for placement.
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`the thickest portion at the bases and the narrowest portions at the center so
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`that it folds during systolic contraction of the left ventricle. The tip of the
`valve would be of a semicircular design to permit the much desjr.ed...la_m.inar~* AjlH,_.,..,.g{....M'v1 :7
`flow characte_ris_ties__..o£theiWa9urt”icvyal§/e. This would decrease the shear stress
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`placed upon the aortic root and ascending aorta. The design rngayykpa sow
`incorporate a semi circular configuration opposing the______M _al_ja>so
`as to disperse the stress upon the aortic valve along a larger surface a a and
`to maximize the flow characteristics to the coronary arteries. This valve
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`would be placed within a catheter system. However a steering and
`placement mechanism, incorporating a connection of removable rods guide
`by a half ball configuration may be necessary. The femoral artery would
`aecessed»':aa1dbt§annulated. _:l:l;eMf_€2,111;Q1;al-3.1_e.i.:l;3?YQ14_ld be sa
`cannulatecl. g9;h.V,ag§fa§j\”ué7§rade andretrogrademappfroiaidlifwould be used to
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`L ‘M visualization would utilize continuous roentgenogram and ultrasound
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`techniques, which are currently available. The most important visualization
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`tool would be ICE (intracardiac echocardiography). In this valve model,
`/ direct connection of the valve to the aortic root would not be utilized unless
`the direction of the jet from the aortic valve made it necessary. The
`, procedure would involve inflation of balloons within the aortic valve and
`1 ascending aorta to deploy the stent/valve combination. If traditional
`valvuloplasty does not produce significant enough opening of the aortic
`valve and relieve the gradient between the left ventricle and aorta then a
`series of further steps may be required.
`Removal of the native aortic valve would not be necessary. The focus
`would instead be upon debulking of the native aortic valve. The central
`theme would hinge upon abolition of the resting gradient. The techniques
`employed would attempt to achieve a large effective aortic valve area
`regardless of the functioning of the native valve post-procedure because an
`artificial valve designed to prevent aortic regurgitation would be in place.
`The valves are designed not to hinder the ejection of blood from the left
`ventricle, and to minimize the aortic regurgitant volume. These techniques
`may include the positioning of an Er»-YSGG percutaneous laser to decalcify
`the valve and repeat balloon aortic valvuloplasty. If not effective then high
`frequency ultrasound percutaneously applied may be necessary. These
`techniques have been shown to be highly effective at producing debulking
`and preventing restenosis. However, they produce tremendous aortic
`regurgitation. This would not be a problem for the unattached valve which
`would work as stated previously for aortic regurgitation. if the desired
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`NORRED EXHIBIT 2253 - Page 2
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`NORRED EXHIBIT 2253 - Page 3
`NORRED EXHIBIT 2253 - Page 3
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`results were not seen then a host of options are still available; for example,
`two rings could be guided onto both the aortic and Ventricular sides of the
`native aortic valve and pneumatically sealed together. Then expandable and
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`A "’”"'”retra‘ctab'le’”bigtomes could be percutaneously placed for cont/rp/1,lgeMd_
`disseetign of the native aortic valve. Along this concept, the biotomes could
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`be used for primary resection without stabilizing rings, but there would need
`to be a stabilization mechanism. Another such mechanism could employ the
`use of a micro screw into the native Valve, which would act as an anchor to
`guide a biotome onto the native valve. Then the biotomes would take small
`snips in a controlled fashion off of the native valve. This would gradually
`increase the effective orifice area.
`because the artificial valve is
`not anchored or dependent upon the native valve for its function, this_____W
`technique could be easily reapplied, if the native valve were toqif6st§pMc3s§;>»«
`without compromising the artificial valve. A tremendous advantage of this
`,, procedure would be its independence from a need for a percutaneous bypass
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`The second valve design could be best desc ibed as a conical design. It
`would be composed of 16 to 32 individua rubber/plastic/metal plates, which
`would be interconnected by resistant_/.fal§fi:c2‘ Figure 2 shows how this valve
`would be connected tcget-her. It would be placed in direct opposition of the
`native aortic valve. It would expand during systole and collapse during
`diastole.
`It would also be anchored along the aortic root wall with
`connecting rods to the ascending aortic stents. The rods would be placed
`between the right and left coronary ostia tangentially along the Einus of
`Valsalva. In this design there would not be any intraluminal rods within the
`ascending aorta as with the umbrella design. The techniques described
`above to relieve the aortic stenosis would also be applicable to this valve.
`This valve however may not be the best valve for isolated aortic
`regurgitation given the direct placement of the valve over the native valve
`may impede opening and create an outflow obstruction. However, given the
`curved and redundant nature of this valve, and the fact that it centralizes the
`ejectionjet from the left ventricle, it may produce the most laminar flow
`characteristics and the le_a§_t,,hematplogie sequelae. The edges may need to
`have a loose rim ofglfiblé Ij[13_1§§_21fial, which act as a flap valve, to help reduce
`peri-valvular leaks (See aplpendix). To minimize components and to aid in
`miniaturizing the device f r delivery, the connecting cones can be reduced to
`2 -» 4 interconnecting rods, which are draped in a sheet of fibrous polymer
`(See appendix).
`
`NORRED EXHIBIT 2253 - Page 4
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