CASE 0:19-cv-01760-PJS-TNL Document 189-17 F ed 12/06/19 Page 1 0t 2
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`Vascular Solutions, Inc.
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`Memo
`
`From: Howard Root
`
`To:
`
`GuideLiner DHF
`
`Date: June 23, 2005
`
`RE: Market Feasibility for the GuideLiner catheters
`
`Background
`
`As part of Phase I of the product development SOP 1043. a review of the market feasibilin of the
`new product is required The Guidel .iner catheter is a new product idea nfa “liner" to he delivered
`inside standard guide catheters to provide the ability to create a deep sealing of the guide for added
`support in thc interventional procedure. The GuideLiner catheter is designed to be used in
`interventional cardiology procedures. Three versions of the GuideLiner product are anticipated: a
`“5in6 GuideLiner". a "6in7 GuideLiner" and a “7inS Guideliner." In addition. it is possible to make
`the GuideLiner in an Over-thc-Wirc version. a Rapid Exchange Version. or both.
`
`Market Feasibility of GuideLiner catheters
`
`The placement of a smaller guide catheter through a larger guide catheter in order to provide added
`support for the crossing of lesions or for the distal delivery of balloons and sterits has been described
`in the literature (Takahashi. "New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter." Catheterization and Cardiovascular Interventions 63:452-456 (2004)). This
`coaxial technique has been used in order to provide a safer method of deep seating the guide
`catheter. The danger of deep seating a nomial guide catheter is that the guide is relatively stiff with
`a fixed curve. which can result in dissections of the coronary artery when advanced past the ostium.
`Using a smaller. and therefore more flexrble. guide catheter (with either no curve or a very gentle
`curve) and placing it through the larger standard guide catheter can reduce this risk to the vessel. By
`safely deep seating the guide catheter, the physician can then have the added support for pushing a
`wire through a chronic total occlusion or advancing a balloon or stcnt through a tight stcnosis.
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`There are several problems with simply using a smaller guide catheter placed coaxially through a
`larger guide. to perform this technique as described in the literature First. a new hemostasis valve
`must be placed on the inner guide catheter. and then the larger guide catheter can‘t be used for
`contrast injections or pressure measurements. and the overall system grows substantially in length
`(to the detriment of using standard tools to reach distal lesions). Second. the smaller guide catheter
`still must be inserted carefully into the coronary vessel since there is no tapered transition or
`dilator/obturator for insertion. And finally. a guide catheter used as a guide liner is not as flexible as
`is desired for insertion into the coronary artery.
`
`A specifically designed guide liner product would have substantial market potential. Worldwide.
`there are over tvxo million coronary interventions performed each year. Each of these procedures
`utilizes a guide catheter for gaining access to the coronary vessel (with a separate guide for the right
`and lcfi). Because currently there is no guide lincr product available. it is difficult to estimate the
`percentage of coronary interventions where a guide liner would be used. Estimating the incidence at
`just 1% would yield an annual market opportunity of over 20.000 procedures a year. Estimating a
`selling price of- per unit would create an animal market opportunity 0-. which is
`above the company's_ annual market threshold for developing a new product.
`
`Confidential - Attorneys' Eyes Only
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`EXHIBIT 17
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`Page 1
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`VSIMDT00030170
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`Teleflex EX. 2128
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`Medtronic v. Teleflex
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`IPR2020-00135
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`
`Page 1
`
`Teleflex Ex. 2128
`Medtronic v. Teleflex
`IPR2020-00135
`
`

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`CASE 0:19-cv-01760-PJS-TNL Document 189-17 F ed 12/06/19 Page 2 of 2
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`EXHIBIT 17
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`Page 2
`
`Teleflex Ex. 2128
`Medtronic v. Teleflex
`IPR2020-00135
`
`