CASE 0:13-cv-01172-JRT-SER Document 12 Filed 06/10/13 Page 1of55
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Vascular Solutions, Inc.,
`
`Civil File No. 0: 13-cv-01172 (JRT-SER)
`
`Plaintiff,
`
`v.
`
`Boston Scientific Corporation,
`
`Defendant.
`
`DECLARATION OF HOWARD ROOT
`IN SUPPORT OF PLAINTIFF'S
`MOTION FOR PRELIMINARY
`INJUNCTION
`
`I, Howard Root, hereby declare and state as follows:
`
`1.
`
`I am the Chief Executive Officer of Plaintiff Vascular Solutions, Inc.
`
`("VSI"). I make this Declaration in connection with VSI's motion for a preliminary
`
`injunction. I have personal knowledge of the matters set forth below and, if called as a
`
`witness, I could and would testify as follows.
`
`Background
`
`2.
`
`I was originally trained as a lawyer and worked in private practice from
`
`1985-90. In 1990, I left private practice to serve as General Counsel to ATS Medical,
`
`Inc., a medical device company. I left ATS Medical and founded VSI in 1997, and I
`
`have acted as the Chief Executive Officer ofVSI since its founding. Since 1997, I have
`
`been personally involved in the creation and development ofVSl's products. I am a
`
`named inventor on 10 patents relating to a variety ofVSI's products, including patents in
`
`the following areas: vascular access closure systems, coaxial guide extension catheters,
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`guidewire tipped laser fibers, screw tipped penetrating catheters, and retraction belts.
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`3.
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`At different times during the company's history, I have directly managed the
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`VSI sales force, product development and marketing departments, and during all times
`
`have been personally active in VSI's sales, product development, legal and marketing
`
`efforts.
`
`4.
`
`VSI is a medical device company focused on bringing new clinically unique
`
`solutions for vascular diseases to physicians worldwide. VSI has developed and markets
`
`over 75 different medical device products through its 91employee U.S. sales force and
`
`international distribution network covering 49 countries. VSI had revenue of $98 million
`
`in 2012.
`
`Background on the Technology of this Case
`
`5.
`
`The technology involved in this case involves cardiac (heart) catheterization,
`
`and more specifically, a medical advance that enables cardiologists to navigate medical
`
`instruments such as stents through narrow and tortuous arteries in order to treat arterial
`
`disease in coronary vessels that often could not be reached with previous technologies.
`
`6.
`
`In coronary artery disease, a coronary artery is narrowed or occluded, often
`
`by the buildup of plaque which can reduce or entirely obstruct blood flow through the
`
`artery. A narrowing in an artery is referred to as a lesion or a stenosis. If a stenosis
`
`becomes severe, the heart muscle will not receive sufficient blood flow to continue to
`
`function appropriately, which can result in an acute myocardial infarction, commonly
`
`known as a heart attack. A coronary artery stenosis is depicted in the drawing below:
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`2
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`Coronary Artery
`Stenosis
`
`7. When a patient is suspected of having a significant stenosis in a coronary
`
`artery, the cardiologist often will perform a diagnostic coronary catheterization procedure
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`to confirm the condition. A diagnostic catheterization consists of injecting contrast
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`(radiopaque dye visible on an x-ray) through a diagnostic catheter (a long, thin tube)
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`placed into the beginning of the coronary artery while viewing the artery under x-ray.
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`The x-ray will show the presence of the radiopaque dye in the open portion of the
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`coronary artery and the absence of dye in the area of the stenosis. A drawing of a
`
`diagnostic catheterization and an x-ray image from a diagnostic catheterization are shown
`
`below:
`
`Catheter
`
`Right Coronary
`Artery
`
`Radiopaque dye in
`coronary artery
`
`Diagnostic catheter
`
`left Coronary
`Artery
`
`Stenosis
`(blockage)
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`3
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`8.
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`If the diagnostic catheterization confirms a clinically significant stenos is
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`(such as identified in the x-ray above), the cardiologist will often perform what is called
`
`an interventional catheterization to treat (or intervene) by opening the stenosis. An
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`interventional catheterization procedure consists of delivering medical instruments such
`
`as stents and balloons into the coronary artery and across the stenosis and then expanding
`
`the balloon and/or stent to push the stenosis to the arterial wall and re-open flow through
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`the artery. Below is a drawing of a stent that has been opened to push a stenosis to the
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`arterial wall and restore flow through the artery:
`
`Stent
`(deployed)
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`9.
`
`Cardiac catheterization procedures, whether diagnostic or interventional, are
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`non-surgical, minimally invasive medical procedures. A cardiac catheterization starts
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`with a needle puncture in the radial (wrist) or femoral (leg) artery of the patient in order
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`to gain access to the arterial system. Through the hollow needle that punctured the artery
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`a guidewire is inserted, after which the needle is removed and an introducer sheath (a
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`short, thin tube with a valve on the end outside the body to prevent blood from leaking
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`out) is inserted over the wire and into the artery. The introducer sheath is then used to
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`provide continued access to the artery for the introduction of guidewires, catheters and
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`stents during the procedure. This type of arterial access is commonly known as the
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`Seldinger technique, and is shown in the drawings below
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`1. Needle puncture
`
`2. Guidewire inserted
`throu!!h needle /
`
`3. Needle removed
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`4. Introducer Sheath
`inserted over wire y
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`10. Using the introducer sheath as the conduit, to perform a diagnostic
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`catheterization procedure the cardiologist will advance a diagnostic catheter into and
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`through the aorta until it is pointing at the opening (ostium) of the coronary artery to be
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`diagnosed (the right or left coronary artery). Once in position, dye is injected through the
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`diagnostic catheter and into the coronary artery to allow the size and shape (and any
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`lesions) of the artery to be observed under x-ray (see the drawing and image in paragraph
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`7 above). Because only dye (which is in liquid form) is injected into the coronary artery
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`during a diagnostic catheterization procedure, a diagnostic catheter can have a small inner
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`diameter and the tip of the diagnostic catheter does not need to precisely match the shape
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`of the ostium of the coronary artery.
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`11.
`
`In an interventional catheterization procedure, instead of using a diagnostic
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`catheter the cardiologist will use what is commonly referred to as a "guide catheter" to
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`deliver (or guide) medical devices (such as stents) into the coronary artery to the site of
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`the stenosis to perform the intervention. Because the purpose of an interventional
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`catheterization is to deliver medical instruments such as stents deep into the coronary
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`artery and across the stenosis, a guide catheter must have a large enough inner diameter
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`to allow passage of the commonly-used stents as well as an appropriate shape and
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`structure to prevent dislodgement during delivery of the devices. Below is a drawing of a
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`guide catheter seated in the coronary artery ostium (shown at 60) with an unexpanded
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`stent in place across a stenosis (shown at 66) from Figure 7 ofVSI's U.S. Patent No.
`
`8,048,032 ('032 patent):
`
`Guide
`catheter
`
`Stent
`(undeployed)
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`12. The guide catheter is a critical component of an interventional coronary
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`catheterization procedure, as it is a required tool to provide the pathway for medical
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`devices to be delivered from a distal arterial access point to a lesion for treatment. Many
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`companies manufacture and sell guide catheters, including Boston Scientific. A standard
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`guide catheter has a length of 1 OOcm and has a diameter measured on the French scale
`
`(abbreviated "F"), where lF is 1/3mm. The most common size of guide catheter is 6F
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`(i.e., it has an outside diameter of 2mm (0.079in)), while other common sizes are 7F and
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`8F. Below is a drawing of a guide catheter:
`
`Guide catheter
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`13. During use, the proximal end (i.e., the end outside the body) of a guide
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`catheter must be sealed to prevent blood loss during the catheterization procedure. To
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`provide this seal (while still allowing the guide catheter to be opened for delivery of
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`medical devices), a hemostasis valve (such as the one depicted below) is attached to the
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`proximal end of the guide catheter.
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`Hemostasis valve
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`7
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`14. A guide catheter must be sufficiently rigid to allow it to maintain its distal
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`curve (the distal end being the far end, deepest inside the body) while medical devices
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`such as stents (which are relatively inflexible) are directed from the aorta through a 90°
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`bend and into the ostium of the coronary artery to be treated. The guide catheter also
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`must provide sufficient "backup" support to prevent the guide catheter from moving
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`backwards and becoming dislodged from the ostium as the medical devices are pushed
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`through a tight stenosis. Without this combination of guide catheter rigidity and backup
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`support, medical devices such as stents may not be able to traverse the artery and cross
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`the stenosis, causing the intervention to fail. Because the shape and location of coronary
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`ostia vary widely among patients, guide catheters are manufactured with a wide variety of
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`curve shapes to provide orientation and back-up support in these variations. Below are
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`three common distal curve styles of guide catheters for right (JR4 and Hockey Stick) and
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`left (EBU) coronary artery catheterizations:
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`8
`
`-
`
`- - -~---- - - · ~---·-----
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`15. However, because of the curve and rigidity of a guide catheter, it generally
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`cannot be safely "deep seated" (i.e., extended past the ostium) into the coronary artery,
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`and instead must rest in the ostium. Therefore, while deep-seating of the guide would be
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`helpful to significantly increase the resistance to backup and dislodgement during the
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`stent delivery, it is generally not performed. The resulting limitation on backup support
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`can result in dislodgement of the guide catheter and failure to deliver the treatment in
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`challenging cases where the anatomy is tortuous and the lesion is severe, which are
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`precisely the cases where treatment is often most needed.
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`16. There have been prior attempts to solve this desire to safely deep seat a
`
`guide catheter, as discussed in VSI's '032 patent, at col. 1, In. 41, to col. 2, In. 44. One
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`prior approach is referred to as a "mother and child" guide catheter. It involves inserting,
`
`for example, a 5F, 120cm "child" guide catheter that has a relatively flexible and straight
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`distal tip through a standard 6F, 1 OOcm "mother" guide catheter that is already in place at
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`the ostium of the coronary artery. The distal end of the child catheter, being flexible and
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`straight, can therefore safely extend through the ostium, into the bend in the artery and
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`provide excellent backup support. Drawings of a mother and child guide catheter system
`
`and its use in a coronary artery are below:
`
`Mother and child OTW system
`
`"Mother" guide catheter
`
`•
`
`"Child" guide catheter
`
`Hemostatic valves
`
`9
`
`-
`
`-
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`-
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`"Child" guide catheter
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`17. The Heartrail guide catheter manufactured by Terumo Corporation is an
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`example of this "mother and child" guide catheter system, comprised of a 120cm long 5F
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`child guide catheter extension paired with a 1 OOcm long 6F mother guide catheter. The
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`radiographic image below depicts the Terumo Heartrail mother and child system in use
`
`under x-ray visualization, with a stent extended through both the mother and child:
`
`18. The mother and child system promoted by Terumo, however, has several
`
`drawbacks. One drawback is that the system requires two hemostatic valves: one to seal
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`CASE 0:13-cv-01172-JRT-SER Document 12 Filed 06/10/13 Page 11of55
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`the mother catheter, and a second to seal the child catheter. This tends to make the
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`system cumbersome to use. Another drawback is the length of the system - the mother
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`and child combination results in a 120cm long guide catheter, which limits the sites that
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`can be treated since balloons, stents and wires are designed to be used with 1 OOcm guide
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`catheters. Third, to insert or remove the child catheter, all of the previously inserted
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`medical devices, such as guidewires, must be removed. This is particularly problematic
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`in situations where the cardiologist did not originally plan to use a child catheter, but
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`instead the need arose in the middle of the procedure, but then requires removing all
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`guidewires that have already been appropriately placed and starting the intervention over
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`from the first step. As a result, before the GuideLiner, the mother and child system was
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`rarely used.
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`19. The mother and child guide system utilized by Terumo is an example of an
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`over-the-wire, or OTW, catheter. An OTW catheter has at least one uninterrupted lumen
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`that runs the entire length of the catheter which is used for delivery of the catheter over a
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`guidewire (i.e., the entire length of the OTW catheter is delivered "over the wire") and
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`into the artery. Because an OTW catheter is generally between lOOcm and 150cm in
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`length, it usually requires a long (between 260 and 300cm) guidewire for deployment,
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`which necessitates two operators to control both ends of the catheter at the same time as it
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`is being deployed. Shown below is a schematic drawing of a standard OTW catheter
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`with a guidewire extending through it:
`
`Over-the-wire (OTW) catheter
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`20. An alternative type of catheter used in coronary catheterization procedures is
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`referred to as monorail, rapid exchange, single operator, or sliding rail. All of these
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`names refer to the same type of catheter construction with a relatively short (generally
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`20cm - 40cm) lumen used to deliver the catheter over a guidewire, attached to a longer
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`and stiffer push rod that is used to push and retract the catheter but runs independent of
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`and next to the guidewire. With the monorail construction, a single operator is able to
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`deliver the catheter and control both ends during delivery. It also allows the use of
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`shorter guidewires (between 150cm and 190cm in length). This rail technique is
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`explained in an article by Bonzel et al., Z. Kardiol. 1987; 76 Suppl. 6:119-22. A true and
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`correct copy of the Bonzel et al. article is attached as Exhibit 1. Shown below is a
`
`schematic drawing showing a standard "rail" or rapid exchange catheter with a guidewire
`
`placed through it:
`
`Rail (rapid exchange) catheter
`
`VSl's Development of the GuideLiner® Catheter and the Patents-in-Suit
`
`21.
`
`Starting in 2004, I, along with other VSI employees Gregg Sutton, Jeffrey
`
`Welch, and Jason Garrity, conceived of and began to work on a new idea for a guide
`
`extension catheter that would provide "mother and child" guide extension, but without
`
`the disadvantages of the OTW construction. After years of research and testing, we
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`developed our idea into VSI's GuideLiner catheter, which was first sold in 2009. The
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`GuideLiner catheter provides the advantages of "mother and child" guide extension with
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`the ease of monorail or rapid exchange delivery. The original GuideLiner catheter is
`
`depicted below.
`
`t
`Flexible tube
`with lumen
`
`VSl's GuideLiner catheter
`t
`t
`Rigid collar
`Substantially rigid push rod
`with no lumen
`
`22. The distal end (yellow and blue portion) of the GuideLiner catheter is a
`
`relatively flexible tube with a lumen. This flexible portion has three zones: a very
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`flexible yellow tip, a less flexible yellow coil reinforced portion, and a further less
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`flexible blue portion made from a stiffer polymer as shown below:
`
`GuideLiner
`very flexible tip
`
`Coil reinforced portion
`More flexible
`Less flexible
`
`23. The flexible tube portion of the GuideLiner is joined to a relatively
`
`inflexible metal collar where the lumen ends with a sloped opening:
`
`GuideLiner collar side view
`
`GuideLiner collar top down view
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`24. The collar is then connected to a substantially rigid push rod that extends for
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`the remainder of the length of the GuideLiner catheter:
`
`GuideLiner substantially rigid push rod
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`25. The proximal end of the push rod is embedded into a tab used to identify the
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`GuideLiner catheter and prevent it from being inadvertently pushed through the
`
`hemostatic valve:
`
`GuideLiner proximal tab
`
`26.
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`In use, the "child" GuideLiner catheter is inserted into the "mother" guide
`
`catheter by threading the lumen of the GuideLiner catheter' s tubular portion over the in(cid:173)
`
`place guidewire. The GuideLiner catheter's flexible tip is pushed through the guide
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`catheter by the attached push rod and out the distal end of the "mother" guide catheter for
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`deep seating into the coronary artery. After the GuideLiner catheter has been fully
`
`inserted into the guide catheter, when a cardiologist inserts a device such as a stent into
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`the guide catheter, the device will travel down the guide catheter, next to the push rod,
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`until it encounters the collar, where it will pass through the sloped opening in the collar
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`and into the flexible tip portion and continue until it exits the distal end of the GuideLiner
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`catheter's flexible tip portion, into the artery to be treated.
`
`27. By extending past the distal tip of the guide catheter and into the artery to be
`
`treated, the GuideLiner catheter provides superior back-up support through effective deep
`
`seating. And because the GuideLiner catheter's tip is flexible, the catheter can be deep
`
`seated without the risks associated with deep seating standard, much more rigid guide
`
`catheters.
`
`28. The use of the GuideLiner catheter is illustrated in the two figures below. In
`
`the figure on the left, without the GuideLiner in place, the guide catheter has backed out
`
`of the coronary ostium, possibly from the force exerted on advancing the guidewire. In
`
`the figure on the right, the GuideLiner catheter extension has been deep seated, thus
`
`providing added support for the advancement of guidewires and stents into the artery.
`
`Without GuideLiner
`(backed out of ostium)
`
`With GuideLiner
`(deep seated)
`
`Guide catheter
`(blue)
`
`GuideLiner
`(yellow) ----.......
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`29.
`
`In another example of the use of the GuideLiner, in the illustration below on
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`the left, without the use of a GuideLiner catheter the rigid stent cannot navigate the sharp
`
`downward turn of the vessel to reach the lesion, and therefore the procedure cannot be
`
`completed. In the figure on the right, with the use of the GuideLiner the angulated
`
`vessel's sharp angle is turned into a gentle curve, which allows the stent to make the tum
`
`and be delivered to the lesion.
`
`Without GuideLiner
`(failure to deliver stent)
`
`With GuideLiner
`(stent delivered to stenosis)
`
`~ Guide catheter
`~ (blue)
`
`GuideLiner
`(yellow) ~
`
`Stent~
`(across stenosis)
`
`30. The monorail construction of the GuideLiner catheter provides multiple
`
`advantages to the user over the OTW construction used in prior "mother and child"
`
`systems. Because only the push rod extends through the hemostatic valve when using the
`
`GuideLiner catheter, a second hemostatic valve is not needed. In addition, since only one
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`hemostatic valve is used, there is no need to use longer devices to reach the lesion or any
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`limitation on the length of devices used. Furthermore, the monorail construction allows
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`the existing guidewires to remain in place while delivering the GuideLiner catheter into
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`the artery, which is particularly beneficial in unplanned uses.
`
`31. A second version of the GuideLiner catheter named the V2 was developed
`
`and sold beginning in 2012. The changes in the V2 version did not change the
`
`deployment, use or general construction of the GuideLiner catheter. The only changes
`
`made in the V2 version from the original GuideLiner (now called Vl) were (a) the length
`
`of the guide extension segment was increased from 20cm to 25cm, (b) a second
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`radiopaque marker band was added to the collar section of the catheter, and ( c) the metal
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`of the collar section was replaced with a polymer material. The first figure below is a
`
`schematic of the original ("VI ") GuideLiner catheter, and the second figure is a
`
`schematic of the second version ("V2") of the GuideLiner catheter.
`
`1-
`
`LI I
`
`GuideLiner V1
`
`145cm
`
`20cm
`
`c ~---=\\---_-_.....--,.,.r----r--r;
`
`------~=-"
`
`Guideliner V2
`
`150cm
`
`25cm
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`32. On May 3, 2006, my coinventors and I filed a patent application on our
`
`invention in the U.S. Patent Office. Our application led to three U.S. patents, each of
`
`which is assigned to VSI: the '032 patent, which issued November 1, 2011; U.S. Patent
`
`No. 8,142,413 ('413 patent), which issued March 27, 2012; and U.S. Patent No.
`
`8,292,850 ('850 patent), which issued October 23, 2012. Each of these patents is entitled
`
`"Coaxial Guide Catheter for Interventional Cardiology Procedures."
`
`33. A true and correct copy ofVSI's '032 patent is attached as Exhibit 2.
`
`34. A true and correct copy of VSI's '413 patent is attached as Exhibit 3.
`
`35. A true and correct copy of VSI's '850 patent is attached as Exhibit 4.
`
`36. Both the GuideLiner Vl and the GuideLiner V2 are embodiments of the
`
`coaxial guide catheter described and claimed in the VSI patents. In general, the '032
`
`patent claims the device, the '413 patent claims methods of using the device, and the '850
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`patent claims systems combining the GuideLiner device with a guide catheter. For
`
`example, claim 1 of the '032 patent claims a device for use with a standard guide catheter
`
`to provide guide extension, with the device having a "flexible tip portion" and a
`
`"substantially rigid portion" as described above in my description of the GuideLiner
`
`products.
`
`Success of VSl's GuideLiner catheter
`
`37. VSI obtained CE mark clearance from its European notified body and
`
`commenced international sales of the GuideLiner catheter in September 2009.
`
`38. VSI obtained 510(k) regulatory clearance from the U.S. Food & Drug
`
`Administration and commenced U.S. sales of the GuideLiner catheter in November 2009.
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`39. The GuideLiner catheter has been a very successful product for VSI.
`
`Worldwide sales of the GuideLiner catheter since launch are provided in the table below.
`
`Year
`2009
`(4th quarter only)
`2010
`2011
`2012
`2013
`(1st quarter only)
`Total
`(throu2h March 31, 2013)
`
`Worldwide
`Sales
`
`$318,000
`
`$4,632,000
`$9,753,000
`$14,742,000
`
`$4,781,000
`
`$34,226,000
`
`40.
`
`From 2010 to current, the GuideLiner catheter has been VSI's fastest
`
`growing product, with sales growth of 48% in the first quarter of 2013 over the first
`
`quarter of 2012.
`
`41.
`
`In 2012, the GuideLiner catheter was VSI's third highest-selling product in
`
`the United States, and second highest-selling product worldwide. I expect that
`
`GuideLiner catheters will be VSI's highest-selling product both in the United States and
`
`worldwide in 2013. GuideLiner catheter sales currently represent approximately 20% of
`
`VSI's total revenue.
`
`42. Because of the completely unique nature of the GuideLiner catheter, it
`
`provides our sales force access to hospitals to sell other VSI products, and gives our sales
`
`force added credibility in that sales process. Many U.S. hospitals that have purchased the
`
`GuideLiner catheter had not purchased a VSI product in the year prior to their initial
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`purchase of a GuideLiner catheter. VSI would not have had access to these customers,
`
`and most of these customers subsequently purchased additional VSI products. I have
`
`prepared as Exhibit 41 a chart setting out the total number of U.S. hospitals that have
`
`purchased a GuideLiner catheter since launch, the number of those customers who were
`
`new customers to VSI, in the sense that they had not purchased a VSI product in the year
`
`before their purchase of the GuideLiner catheter, and the average number of additional
`
`VSI products purchased by these new customers after purchasing the GuideLiner. VSI
`
`considers this level of detailed customer information to be confidential, and I respectfully
`
`ask that the Court allow us to file that exhibit under seal. I understand that counsel will
`
`be filing a separate motion seeking permission to file Exhibit 41 under seal.
`
`43.
`
`Since 2010, twenty-two articles have been published in medical journals on
`
`the GuideLiner catheter and five medical symposia have been held on the GuideLiner
`
`catheter at medical meetings held in the United States and Europe. In addition, VSI has
`
`published twelve case reports on a range of beneficial clinical uses of the GuideLiner
`
`catheter. Attached as Exhibit 5 is a true and correct copy of a bibliography listing
`
`GuideLiner catheter publications, symposia, and case reports. Attached as Exhibits 6-13
`
`are true and correct copies of articles on the GuideLiner catheter. Attached as Exhibit 14
`
`are clinical case reports on GuideLiner published by VSI.
`
`44. The GuideLiner catheter has been recognized by physicians as a unique and
`
`substantial advance in cardiac catheterization. For example:
`
`a.
`
`From the article Device of the Month: Catheter addresses
`
`challenging coronary interventions (Ex. 6):
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`• "The GuideLiner catheter, released in November 2009 and now available
`for sale in the United States and Europe, is being called a 'game-changer'
`for the treatment of complex endovascular lesions."
`
`•
`
`"[Use of GuideLiner] greatly facilitates stent delivery, leading to a
`successful outcome after failure of conventional techniques. This allows
`complex disease to be treated more confidently, more easily and more
`safely." (quoting Douglas G. Fraser, MD, BM, BChir)
`
`• "I've been able to treat arteries previously deemed ' untreatable' and have
`reported on this. It is not hyperbole to refer to the GuideLiner as a game(cid:173)
`changing device." (quoting Kanwar P. Singh, MD, FACC)
`
`•
`
`"According to Singh, currently in the United States, there is no competitor
`device to the GuideLiner."
`
`b.
`
`From the article The GuideLiner™ "child" catheter (Ex. 7):
`
`• "In this case, stent delivery was impossible despite the use of a highly
`supportive guiding catheter. By using the GuideLiner™, the stent was
`deployed easily and successfully because of the extra-back up support and
`deep intubation without any displacement of the guide catheter or any
`vessel trauma. The GuideLiner™ provides a new alternative for
`performing complex interventions."
`
`c.
`
`From the article Usefalness and safety of the GuideLiner catheter to
`
`enhance intubation and support of guide catheters: insights from the Twente GuideLiner
`
`registry (Ex. 8):
`
`• "[GuideLiner] use resulted in increased back-up and guide catheter
`alignment for stent delivery in unfavourable tortuous anatomies and
`complex, heavily calcified, and often distally located lesions, which
`otherwise may have been considered unsuitable for PCI [percutaneous
`coronary intervention]. Procedural success rate was high and there were no
`major complications."
`
`• GuideLiner "is a novel rapid exchange guide catheter extension system."
`
`•
`
`"During the first months, the GL was used as a bailout device in
`challenging cases, when the 'old familiar tricks' (e.g., deep-seating
`manoeuvres or use of buddy wires) had failed."
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`d.
`
`From the article GuideLiner Catheter Facilitated PC/ -A Novel
`
`Device with Multiple Applications (Ex. 9):
`
`•
`
`•
`
`"The GuideLiner catheter (Vascular Solutions, Inc.) is a novel device that is
`FDA approved and CE marked for assistance with device delivery during
`coronary interventional procedures."
`
`"The GuideLiner catheter has greatly simplified coronary intervention and
`broadened the lesion subsets that can be safely treated with 6 Fr guiding
`catheters and via the radial approach."
`
`e.
`
`From the article Use of the GuideLiner Catheter for the Treatment of
`
`a Bifurcational Total Occlusion of the Native Left Anterior Descending Artery through a
`
`Tortuous Composite Venous Graft (Ex. 11):
`
`• "Our case illustrates the efficacy of the GuideLiner catheter in providing
`the support needed for crossing a CTO and for stent delivery in challenging
`cases. We used it up front due to previous failure in advancing a guidewire
`and a support catheter through the SVG."
`
`•
`
`"We report the first case of GuideLiner use in complex native coronary
`artery intervention through a venous graft. The atraumatic deep-seating
`allowed by this device provided the extra support needed to cross a CTO
`beyond tortuous segments and to advance devices through sharp
`angulations. In addition, its monorail design allowed its easy advancement
`through the hemostatic valve and easy handling of balloons and stents."
`
`f.
`
`From the article The GuideLiner "Child" Catheter for Percutaneous
`
`Coronary Intervention - Early Clinical Experience (Ex. 12):
`
`•
`
`"All cases involved intervention of the RCA, for which extra backup
`support is often required. In some cases, stent delivery was impossible
`despite the use of a highly supportive guiding catheter, buddy wires and a
`buddy balloon. The GuideLiner catheter provided the additional backup
`support required for stent delivery. Deep target-vessel intubation was
`possible without displacement of the guiding catheter/wire or vessel
`trauma."
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`g.
`
`From the article Distal Stent Delivery With Guideliner Catheter:
`
`First in Man Experience (Ex. 13):
`
`•
`
`•
`
`•
`
`"The GuideLiner catheter was used for