`VASCULAR SOLUTIONS LLC;
`TELEFLEX INNOVATIONS S.á R.L.,
`ARROW INTERNATIONAL, INC.,
`AND TELEFLEX LLC,
`
`
`Plaintiffs/
`Counterclaim Defendants,
`
`Court File No. 0:19-cv-01760 (PJS/TNL)
`
`
`
`REDACTED
`
`DECLARATION OF JAMES PHELAN IN
`OPPOSITION TO MOTION FOR
`PRELIMINARY INJUNCTION
`
`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 1 of 8
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`
`
`v.
`
`
`MEDTRONIC, INC. AND
`MEDTRONIC VASCULAR, INC.,
`
`
`Defendants/
`Counterclaim Plaintiffs.
`
`
`
`I, James Phelan, declare as follows:
`
`1.
`
`I am Senior Program Manager, R&D for Medtronic, Inc. I make this
`
`declaration in opposition to Plaintiffs’ motion for a preliminary injunction.
`
`2.
`
`I have worked at Medtronic for ten years. In my role as Senior Program
`
`Manager, R&D, my responsibilities include leading product development programs. I
`
`was part of the team that developed the Telescope™ extension guide catheter (GEC) and
`
`make this declaration based on personal knowledge.
`
`3.
`
`Defendant Medtronic, Inc. is a pioneer in interventional cardiology, and
`
`offers hundreds of products used in interventional cardiology procedures. The use of
`
`catheter-based technologies to treat coronary artery disease has been around for decades,
`
`and is not new by any means.
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`
`
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`Page 1
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 2 of 8
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`
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`4.
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`Guide catheters are a critical component of interventional cardiology. They
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`are used by surgeons to deliver a balloon or stent into a coronary artery that has been
`
`narrowed by a buildup of plaque. The surgeon first pushes a guide catheter to the ostium
`
`of the heart. In difficult cases, the surgeon may also use a guide extension catheter,
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`which is inserted into the guide catheter. The stent or balloon travels through the guide
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`catheter and, if one is being used, the guide extension catheter, to the area of the artery
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`that needs treatment. Medtronic is among the market leaders for devices used in
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`interventional cardiology procedures, including guide catheters, stents and balloons.
`
`5.
`
`
`
`
`
`
`
`6.
`
`Starting in 2015, we sought input from over 250 interventional
`
`cardiologists concerning their experiences with two of the existing GECs on the market –
`
`the GuideLiner sold by Teleflex, and the Guidezilla sold by Boston Scientific. We also
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`analyzed 580 reports of adverse events involving interventional cardiology procedures
`
`from the FDA MAUDE database. These efforts identified a need for a better device.
`
`7.
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`After identifying opportunity for improvement, our product development
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`team began working to design a device that would perform better. Rather than a “copy”
`
`as Teleflex argues, Medtronic invested several years and
`
` to
`
`develop the GEC that was later named Telescope™. I was the team lead and oversaw the
`
`development process.
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`- 2 -
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`Page 2
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 3 of 8
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`8. We spent more than two years performing extensive preclinical studies.
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`Preclinical studies take place before any testing in humans is done.
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`
`
`
`
`
`
`9.
`
`Telescope™ is different from the GuideLiner and Guidezilla guide
`
`extension catheters in three primary ways, discussed below.
`
`Superior Deliverability
`
`10.
`
`First, Telescope™ has superior deliverability. Deliverability refers to the
`
`physician’s ability to reach the lesion where care is needed. The goal is to allow the
`
`physician to advance the GEC in the blood vessel using less force. The need for
`
`improved deliverability was identified in our conversations with interventional
`
`cardiologists and was a focus of our development efforts.
`
`11. We performed bench testing to determine what force is required to advance
`
`the GuideLiner and Guidezilla GECs. We then experimented with different materials and
`
`configurations and tested their deliverability.
`
`12. We elected to make the pushrod in the Telescope™ stiffer. The pushrod is
`
`a different design than the GuideLiner and Guidezilla GECs.
`
`13.
`
`The stiffer push rod in Telescope™ transfers the force that is applied to it
`
`by the physician better than less stiff push rods. As is shown in the diagram below, the
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`force required to advance Telescope™ is less than for GuideLiner and Guidezilla:
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`- 3 -
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`Page 3
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 4 of 8
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`
`
`
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`Soft Polymer Tip
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`14.
`
`Second, Telescope™ has a unique soft distal tip that reduces the risk of
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`damage to the blood vessel. As with the push rod, our team analyzed several materials
`
`and configurations.
`
`15.
`
`
`
`
`
`
`
`
`
` We ultimately selected a tip that is softer than in GuideLiner and
`
`Guidezilla to reduce the risk of damage to the blood vessel as the GEC is advanced to the
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`lesion. The distal tip in Telescope™ is made from a different material than the main
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`jacket.
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`- 4 -
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`Page 4
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 5 of 8
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`16. Our bench testing demonstrates that the Telescope™ requires less force to
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`deflect from the wall of the blood vessel than GuideLiner and Guidezilla, as shown
`
`below:
`
`
`
`
`
`SmoothPass Technology
`
`17.
`
`Third, we improved the onramp and entry port. One of the problems that
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`can arise with GECs is that the stent or balloon catches or gets stuck when traveling from
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`the pushrod to the entry port. We designed the onramp and entry port in Telescope™ so
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`that interventional devices like stents and balloons pass through safely. We refer to the
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`design features that allow interventional devices to travel safely through the catheter as
`
`our “SmoothPass Technology.”
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`18. When setting out to improve the channeling of interventional devices in the
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`GEC we again experimented with different materials, shapes and configurations. We
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`- 5 -
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 6 of 8
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`selected a design with three key features that naturally orientates within the vasculature
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`and helps channel interventional devices through the device safely. The first feature is
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`that the push wire tapers as it approaches the on-ramp. At the proximal end, the push
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`wire in Telescope™ is solid and round. The push wire tapers and flattens as it
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`approaches the device on-ramp, helping guide the device toward the onramp. The taper
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`also improves GEC flexibility at the aortic arch, helping orient the device in the body.
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`The shape of the push wire is shown in the image below.
`
`
`
`19.
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`Second, we developed a polymer-coated onramp with two distinct tapers to
`
`help channel the stent or balloon, as shown below.
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`- 6 -
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 7 of 8
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`20.
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`Third, the tapered push wire is fused to a marker band with a still polymer,
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`anchoring the proximal and distal sections, and supporting luminal integrity.
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`21. An image of Telescope™ appears below. The structure identified as
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`Number 1 is the soft tip that is on the distal end, furthest from the physician. The
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`structure identified as Number 4 is the pushrod on the proximal end, closest to the
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`physician. The purple structure marked Number 2 includes the onramp and entry port.
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`The green structure identified as Number 3 is a tube that spans the length of the catheter
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`from the onramp to the distal tip.
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`- 7 -
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`Page 7
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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`CASE 0:19-cv-01760-PJS-TNL Document 109 Filed 11/15/19 Page 8 of 8
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`22. Having participated in the extensive product testing we performed during
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`the development of Telescope™, including comparison to GuideLiner and Guidezilla, I
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`believe Telescope™ provides an improved treatment option for physicians.
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` I
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` declare under penalty of perjury that the foregoing is true and correct.
`
`
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`Dated: November 15, 2019
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`
`
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`68235808
`
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`
`
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`
`
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`s/James Phelan
`James Phelan
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`- 8 -
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`Page 8
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`Teleflex Ex. 2206
`Medtronic v. Teleflex
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