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`The aortic valve undergoes a series of changes based upon the initial
`structure at birth and the dynamic stresses whiehithasteundergodafly.
`The trileaflet aortic valve will not become stenotic usually until the 7th
`decade unless infectious processes are introduced sooner. The incidence of
`aortic stenosis can reach between 2 to 9 % in this age range. The average
`mortality 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
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`NORRED EXHIBIT 2053 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`1, 1:11we (’22ILIIM
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`& Medtronic Corevalve, LLC
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`Case |PR2014-00110
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`The trileaflet aortic valve will not become stenotic usually until the 7th
`decade unless infectious processes are introduced sooner. The incidence of
`aortic stenosis can reach between 2 to 9 % in this age range. The average
`modality 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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`NORRED EXHIBIT 2053- Page 1
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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 desiredlaminar" “were
`placed upon the aortic root and ascending aorta The designmaya
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`incorporate a semi circular configuration opposing the?“ uses 0 -
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`by a halfball configuration may be necessary. The femoral artery would bite “.4 ”
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`“M: .W tool would be ICE (intracardiac echocardiography}. In this valve mOdCI’
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`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
`- ascending aorta to deploy the stem/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
`/<,7€M
`ventricle and to minimize the aortic regurgitant volume. These techniques
`may include the positioning of an ErmYSGG percutaneous laser to decalcify/.//1 M“ AMM:
`the valve and repeat balloon aortic valvuloplasty. If not effective then high A/IIf””MM ‘
`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 statedpreviously for aortic regurgitation ifthe des1red
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`NORRED EXHIBIT 2053 - Page 3
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`results were not seen then a host of options are still available; for example, at g,.,,;:tewiwgze
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`two rings could be guided onto both the aortic and ventricular sides of the
`flee/e?
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`native aortic valve and pneumatically sealed together. Then expandable and
`grater/(air;
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`dissection ofthe native aortic valve. Along this concept, the biotomes could
`K/
`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
`“at/“git!”
`snips in a controlled fashion off of the native valve. This would gradually
`,M‘WQ
`My (W increase the effective orifice area. Exeiteingly, because the artificial valve is
`.wee‘e‘y
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`not anchored or dependent upon the native valve for its function, this__________
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`(WW up f, procedure would be its independence from a need for a percutaneous bypass
`m e‘ w pump,
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`would be connected tcgether. 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
`
`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).
`
`{’14,)/(/‘LA/<,(7
`
`If:
`
`NORRED EXHIBIT 2053 - Page 4
`
`
`
`Other valvular designs whichgnay prbe valuable to this technique include
`the usage of cadaver/porcine 1" corp ated valves placed within a
`
`percutaneously stented system
`ould have the benefits of favorable flow
`and hematologic characteristics. T e initial designs are shown in the
`
`appendix. Also tilted disk/duo a design could be hinged and compacted
`Within a percutaneous system to p ovide reasonable partition between the
`
`left ventricle and aorta. Howeve , hese valves have been shown to have less
`favorable hematologic sequelae T e central themes involve increasing the
`effective aortic valve orifice ara Wiiile minimizing the resultant aortic
`
`regurgitation. Thus, the goals in red cing left ventricular energy expenditure
`
`and its resultant long—term suelae f pressure overload would be met with
`this system of percutaneous deliver d aortic valve/s.
`
`
`
`
`NORRED EXHIBIT 2053 - Page 5
`
`