CASE 0:19-cv-01760—PJS—TNL Document 189-2 Filed 12/06/19 Page 1 of 2
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`Vascular Solutions, Inc.
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`Memo
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`From: Howard Root
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`To:
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`GuideLiner DHF
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`Date: February 4, 2005
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`RE: Market Feasibility for the GuideLiner catheters
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`# B
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`ackground
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`As part of Phase I of the product development SOP 1043, a review of the market feasibility of the
`new product is required. The GuideLiner catheter is a new product idea of a “liner” to be delivered
`inside standard guide catheters to provide the ability to create a deep seating of the guide for added
`support in the 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 “7in8 Guideliner”.
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`Market Feasibility of GuideLiner catheters
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`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 stents 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 2452-456 (2004)). This
`“guide liner” technique has been used in order to provide a safer method of deep seating the guide
`catheter. The danger of deep seating a normal 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 flexible, 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 stent through a tight stenosis.
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`There are several problems with using a standard guide catheter as the “guide liner” as described in
`the literature. First, the guide liner must be delivered with an over-the-wire technique since both the
`guide catheter and the guide liner are l00 cm in length. Second, a new hemostais 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. Third, the smaller guide catheter still must be inserted
`carefully into the coronary vessel since there is no tapered transition or dilator on its tip. And
`finally, a guide catheter used as a guide liner is not as flexible as is desired for insertion into the
`coronary artery.
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`A specifically designed guide liner product would have substantial market potential. Worldwide,
`there are approximately 3 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 lefi). Because currently there is no guide liner product available, it is difficult to
`estimate the percentage of coronary interventions where a guide liner would be used. Estimating the
`incidence atjust 1% would yield an annual market opportunity of 30,000 procedures a year.
`Estimating a selling price of- per unit would create an annual market opportunity ot-
`which is above the company’s —annual market threshold for developing a new
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`product.
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`Attorneys Eyes Only
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`VSI_00000774
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`EXHIBIT 2
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`Page 1
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`VSIQXM_E00005947
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`Teleflex EX. 2127
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`Medtronic v. Teleflex
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`Page 1
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`Teleflex Ex. 2127
`Medtronic v. Teleflex
`
`

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`CASE 0:19-cv-01760-PJS-TNL Document 189-2 Filed 12/06/19 Page 2 of 2
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`Page 2
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`Teleflex Ex. 2127
`Medtronic v. Teleflex
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