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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.
`Patent Owner.
`
`
`
`
`IPR2020-00126 (Patent 8,048,032 B2)
`IPR2020-00127 (Patent 8,048,032 B2)
`IPR2020-00128 (Patent RE45,380 E)
`IPR2020-00129 (Patent RE45,380 E)
`IPR2020-00130 (Patent RE45,380 E)
`IPR2020-00132 (Patent RE45,760 E)
`IPR2020-00134 (Patent RE45,760 E)
`IPR2020-00135 (Patent RE45,776 E)
`IPR2020-00136 (Patent RE45,776 E)
`IPR2020-00137 (Patent RE47,379 E)
` IPR2020-00138 (Patent RE47,379 E)
`
`
`
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`
`
`
`Declaration of Dr. Lorenzo Azzalini
`
`I, Dr. Lorenzo Azzalini, hereby declare as follows:
`
`1.
`
`I am currently the Director of Complex Coronary Interventions at
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`VCU Health Pauley Heart Center in Richmond, Virginia, where I am a practicing
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`interventional cardiologist as well as an associate professor of medicine at Virginia
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` 
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`1 
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`

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`Commonwealth University. I received my medical degree from the University of
`
`Padua in Padua, Italy in 2006. I went on to conduct my Cardiology residency at
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`Hospital de la Santa Creu i Sant Pau in Barcelona, Spain, which I completed in
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`2013. After my residency I conducted two Interventional Cardiology fellowships,
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`one in 2013-2015 at the Montreal Heart Institute in Montreal, Quebec, Canada and
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`a second in 2019-2020 at The Mount Sinai Hospital in New York. Between 2015
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`and 2019 I was Co-Director of the Chronic Total Occlusion Program at San
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`Raffaele Hospital, in Milan, Italy. A copy of my CV is attached to this declaration
`
`as Exhibit A.
`
`
`
`2.
`
`Since at least 2013, a major part of my practice has included
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`performing percutaneous coronary intervention (“PCI”) procedures, which
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`includes among other things performing balloon angioplasties and placing stents.
`
`In the course of my career, I have performed thousands of such procedures, and I
`
`closely keep up with new developments and techniques for PCI procedures.
`
`3.
`
`Guide extension catheters, like GuideLiner, have become an
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`indispensable device for interventional cardiologists, particularly those that
`
`practice in the area of complex percutaneous coronary interventions (known as
`
`“complex PCI”).
`
`
`
`4.
`
`Insufficient guide catheter backup support has been a problem for
`
`interventional cardiology procedures since at least the early 1990’s, when
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`2 
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`

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`cardiologists began to perform PCI procedures with some regularity. This was
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`particularly true for what we refer to as “complex” cases where the patient’s
`
`anatomy is difficult to navigate and/or the location and type of lesion being treated
`
`is particularly difficult.
`
`5.
`
`Long before the invention of the GuideLiner, there were various
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`techniques that interventional cardiologists attempted to use to deal with the
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`problem of guide catheter backout (or poor guide catheter support), but these
`
`techniques were often not successful and posed greater risk to the patient. These
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`techniques included use of larger (than otherwise needed) guide catheters for
`
`increased rigidity, deep seating of a guide catheter’s distal end within a coronary
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`artery, and/or use of a second guidewire as part of a “buddy wire” technique. Not
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`only did each of these techniques increase procedural risks to the patient’s health,
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`they each took additional procedure time which can add further risks to the patient.
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`As procedure time is lengthened, the patient’s anatomy is more likely to constrict,
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`a dissection of vessels becomes more likely, plaque on vessel walls is more likely
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`to break off and potentially cause a stroke or distal embolization (which can lead to
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`acute myocardial infarction), the patient may be subjected to excessive amounts of
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`contrast media (which are deleterious for the kidneys), and the patient is subjected
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`to more radiation in connection with fluoroscopic imaging (which exposes the
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`patient to higher risk for skin injury and potentially cancer). For at least these
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`3 
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`reasons, pre-GuideLiner techniques for dealing with the long-existing problem of
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`poor guide catheter support were not desirable solutions.
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`
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`6.
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`Another technique that was employed to try to deal with the problem
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`of poor guide support was to use a longer, full-length over-the-wire catheter inside
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`a guide catheter and two hemostasis valves in what is referred to as a “mother-and-
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`child” configuration. This approach was not a desirable solution and was never
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`widely adopted. Among other reasons, in the vast majority of cases the cardiologist
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`does not determine that a guide extension catheter is needed until the middle of the
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`procedure. Given the overall length of the mother-and-child configuration, a 270-
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`400 cm guidewire is necessary to employ this technique, but such a guidewire
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`length is not what interventional cardiologists typically start a procedure with due
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`to the need for a dedicated second operator helping with balloon and stent
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`exchange. Rather, a shorter 180-190 cm “rapid exchange length” guidewire is
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`commonly used as this is compatible with the rapid exchange balloons and stents
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`used to treat coronary lesions and can be manipulated by a single operator.
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`Accordingly, to attempt the mother-and-child technique, the cardiologist would
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`have to pull out the already positioned rapid exchange length guidewire and
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`replace it with a longer guidewire. This is highly undesirable because once a
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`guidewire is in place across a lesion to be treated the interventional cardiologist
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`does not want to lose that position. It is often difficult, and sometimes impossible,
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`to regain that guidewire position a second time with the longer wire. Even if the
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`guidewire position can be regained, it will be a considerable loss of time, further
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`subjecting the patient to the risks discussed above.
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`
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`7.
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`The mother-and-child approach also needs two operators. This need
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`for two operators is highly undesirable because needing two operators means there
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`are two sets of hands being controlled by two people where coordination is
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`important. Inevitably there are miscommunications and misleading tactile
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`feedback, both of which can inhibit successful performance of an interventional
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`procedure. Requiring two operators also adds significant costs to the procedure.
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`
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`8.
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`For all of these reasons, the mother-and-child technique did not solve
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`the long-existing problem of insufficient backup support.
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`
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`9. When the GuideLiner product launched in 2009, it changed the field
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`of interventional cardiology for the better. It gave cardiologists a completely new
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`type of device that finally solved the long-existing guide catheter backout problem.
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`Back in that period, I remember senior interventional cardiologists hailing the
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`introduction of this new device as a major breakthrough in our specialty, greatly
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`simplifying and improving balloon and particularly stent delivery through tortuous
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`and calcified coronary arteries.
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`10.
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`I have used GuideLiner devices over 400 times. In my opinion,
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`GuideLiner provided cardiologists, for the first time, with a rapid exchange device
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`5 
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`(i.e., a device usable with the shorter 180-190 cm rapid exchange length guidewire)
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`that could readily be used to provide backup support. The GuideLiner could be
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`advanced into the coronary arteries, beyond the end of the guide catheter, and
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`enable stents and balloons to be delivered to the most difficult of lesions inside the
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`coronary anatomy. The GuideLiner provided these advantages without the
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`drawbacks of the previous ad hoc work-arounds, such as mother-and-child and the
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`buddy wire technique. GuideLiner could be used by a single operator, on the fly
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`(i.e., without the need to remove the previously inserted guidewire and recross the
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`lesion with another, longer wire), with very little additional procedure time and
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`was a remarkably safer approach. GuideLiner reduced the risks of dissection, wire
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`wrap associated with the buddy wire technique, and overexposure to radiation and
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`imaging dye due to excessively laborious and inefficient gimmicks associated with
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`the alternative techniques described above. In my experience, one of the major
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`advantages of GuideLiner was its low profile, and the ability to deliver it to very
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`distal (i.e., deep) locations within the coronary arteries. Once advanced to the
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`desired location, the position achieved by the GuideLiner represented the new
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`“base of operations” from which the operator could deliver the device (e.g., a
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`stent), with much more pushability and ultimately likelihood of achieving the
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`desired final position. In summary, the GuideLiner gave the operator the
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`confidence of a speedy, effortless, and safe delivery of balloons and stents through
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`difficult anatomies.
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`11.
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`In addition, before GuideLiner, some patients could not be
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`successfully treated via interventional means because the cardiologist could not get
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`a stent where it needed to go. Instead, in these situations the interventional
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`cardiologist could only balloon the area and hope it did not subsequently constrict,
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`either acutely or on the long-term. The former problem, called acute vessel closure,
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`represented a complication, and was associated with a high burden of morbidity
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`(heart attack and need for emergent coronary artery bypass graft surgery) and
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`mortality. The latter, called restenosis, was extremely frequent with balloon
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`dilatation alone (30-50%) and brought significant discomfort (angina, need for
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`reintervention) for the patient, and added costs for healthcare systems.
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`12.
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`In my experience, GuideLiner has allowed patients to be treated in a
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`safer and more consistent and reliable manner. Because GuideLiner solved the
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`long felt need for backup support, it has been commercially and clinically
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`successful. Indeed, GuideLiner was the first of its kind in a class of products called
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`“guide extension catheters” and which represent today an indispensable tool in the
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`interventional cardiologist’s armamentarium. Today, both Boston Scientific and
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`Medtronic have competing guide extension catheter products, named Guidezilla
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`and Telescope, respectively, that are very similar to GuideLiner in both structure
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`and function.
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`13.
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`In my experience today, roughly half of complex PCI cases need a
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`guide extension catheter. Cases today are much more complex than 10 years ago.
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`This is due in part because today more people than ever are being treated with
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`percutaneous (i.e., minimally-invasive) coronary intervention, particularly the
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`elderly that are not healthy enough to endure open heart surgery, as well as patients
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`with severe comorbidities (e.g., chronic kidney disease, heart failure, respiratory
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`insufficiency, etc.).
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`
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`14. Further, and importantly, GuideLiner has facilitated and greatly
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`improved various techniques that are available to interventional cardiologists. As
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`an example, GuideLiner greatly improves the technique of proximal to distal
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`stenting, where a series of stents are inserted in which the second (and potentially a
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`third) stent is inserted at a location more distal than the first stent. In this situation,
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`GuideLiner greatly reduced the risk of the second stent catching on the first
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`implanted stent, with the potential to damage it. As another example, the reverse
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`controlled antegrade and retrograde tracking (“reverse CART”) technique was
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`initially utilized at most in roughly 5% of cases of chronic total occlusion
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`percutaneous coronary intervention by a handful of operators worldwide. This was
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`due to the difficulty of the procedure, which could be accomplished only by very
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`skilled operators, and represented a big limitation to its widespread adoption.
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`Today, thanks to the introduction of GuideLiner, this technique has been greatly
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`streamlined, up to the point that reverse CART nowadays represents the most
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`common retrograde chronic total occlusion recanalization technique worldwide.
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`Exhibit 21351 is a journal article published in 2013 that discusses this streamlined
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`reverse CART technique using GuideLiner. Importantly, GuideLiner has given a
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`much wider array of operators the possibility to perform such an otherwise
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`complex technique. For example, I use the technique roughly 70% of the time
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`during retrograde chronic total occlusion recanalization, because it is so much
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`easier to manipulate the retrograde guidewire to enter a GuideLiner (advanced to
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`the mid or distal segment of the occluded coronary artery), compared with having
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`to advance the wire all the way up to the antegrade guide catheter, having to
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`traverse a much longer segment of diseased vessel. As another example, use of
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`GuideLiner in antegrade procedures has greatly increased the efficiency and
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`success rates of chronic total occlusion revascularization, when the Stingray
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`system (Boston Scientific) is utilized. The Stingray system is a re-entry device by
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`which the operator can advance a guidewire from the subintimal space (i.e., within
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`the vessel wall) into the true lumen, after inadvertent or intentional tracking of the
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`antegrade wire dissecting through the layers of the vessel wall. Before the
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` 
`1 Mozid AM et al. Catheter Cardiovasc Interv. 2014;83(6): 929-32.
`9 
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`introduction of GuideLiner, Stingray-based re-entry was hard to teach, not very
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`reproducible, and associated with suboptimal success rates (<50%). Advancing a
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`GuideLiner all the way to the proximal cap of the chronic total occlusion
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`minimizes the amount of blood that can enter the vessel wall thus creating a
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`hematoma and hindering re-entry attempts, which traditionally represented the
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`biggest limitation of Stingray-based re-entry. With this GuideLiner-assisted
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`Stingray-based re-entry, success rates of the procedures climbed up to
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`approximately 80%, which again represents a big advancement for the operators.
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`Finally, GuideLiner has improved the way imaging dye (contrast) is delivered
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`during a procedure. GuideLiner allows for selective contrast delivery in which
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`imaging dye can be delivered in lower amounts (compared with injection from the
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`guide catheter) to specific, targeted coronary vessels which decreases the toxicity
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`risks associated with such dyes and also decreases the risk of a potential hydraulic
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`dissection.
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`15.
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`In my opinion, based on my experience, GuideLiner made cases
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`possible that were previously impossible, and made cases faster, safer, and more
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`reliable. My opinion is shared by many others in my field, based on my
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`professional interactions over the past ten years that the GuideLiner has been
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`available as an interventional cardiology tool. Further, GuideLiner has empowered
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`interventional cardiologists to branch out in new ways, making other procedures
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`more efficient, reliable and safer. So not only was GuideLiner an industry
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`changing device when it was introduced, it continues to be an enabling technology
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`even today, more than 10 years after its introduction.
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`
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`16. As an example, Exhibit 21362 is a case report we published in 2017 in
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`which stent delivery through the subintimal space proved to be extremely difficult.
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`Among other problems, the subadventitial space kept collapsing. GuideLiner was
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`advanced through a long subadventitial channel to overcome this problem and
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`allow stent delivery. An extract of the manuscript concludes: “Advancing the
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`GuideLiner with the stepwise repeated distal-balloon anchoring technique (Figure
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`4B) was crucial to the delivery of long stents to the distal vessel, thus avoiding
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`friction and interference by the distorted struts of the long, crushed, occluded
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`stents”. This is perhaps one of the most remarkable cases I performed with
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`GuideLiner, but such experience is not just anecdotal, as I use the device in
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`roughly 40-50% of my complex cases. For example, I recently performed a case
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`from the radial approach where guide catheter support was suboptimal and
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`GuideLiner was key for two purposes: first, it allowed me to get selective guide
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`catheter engagement in the coronary artery, thus allowing to take better pictures of
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`what I was doing during the intervention; second, it afforded a great amount of
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`support, which proved key to deliver balloons and stents through a very tight
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` 
`2 Candilio L et al. J Invasive Cardiol. 2017;29(12): E190-E194.
`11 
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`stenosis and completing the case without complications and within a short
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`timeframe. Another remarkable case that I recently performed was one where a
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`combination of severe calcification and tortuosity in the right coronary artery
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`would have represented a contraindication for PCI in the pre-GuideLiner era.
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`Instead, I performed rotational atherectomy, and, after that, GuideLiner was
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`necessary to allow balloon and stent delivery (the buddy wire technique failed). I
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`can’t imagine how I would have completed this case otherwise: surely, if it had
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`been successful, it would have taken a much longer time, exposing the patient to a
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`significantly higher risk of complications.
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`17.
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`I know that GuideLiner has received much praise and attention in the
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`interventional cardiology world. For example, a PubMed search with the term
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`“guideliner” brings at least 99 hits
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`(https://pubmed.ncbi.nlm.nih.gov/?term=guideliner&sort=date). This showcases
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`how this device has become a fundamental tool in the interventional cardiologist’s
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`armamentarium. Moreover, many operators (including myself) found that when
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`GuideLiner is used as a first-line strategy during complex interventions (e.g., from
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`the beginning of the procedure, and not only after encountering challenges with
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`balloon/stent delivery), the procedure is greatly facilitated and is carried out in a
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`much more expeditious way.
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`12 
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`18.
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`For my time spent on this matter, I am being compensated at $650 per
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`hour, which is my standard rate for this type of consulting. The compensation for
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`my time is not contingent on the results of these or any other legal proceedings.
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`19.
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`I declare that all statements made herein of my knowledge are true,
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`and that all statements made on information and belief are believed to be true, and
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`that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`Dated: September Z4 , 2020
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`Dr. Lorenzo Azzalini
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`Page 13
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`l3
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`Teleflex EX. 2151
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`Medtronic v. Teleflex
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`IPR2020-00135
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`

`

`Lorenzo Azzalini
`MD PhD MSc
`
`11832 Park Forest Way
`Glen Allen, VA – 23059 USA
`(cid:72) +1 (347) 330-3246
`(cid:66) azzalini@gmail.com
`
`General data
`Date of birth September 25th, 1981
`Place of birth Venice, Italy
`Citizenship Italian
`U. S.
`Permanent resident
`immigration
`status
`
`July 2020 –
`present
`
`July 2020 –
`present
`
`July 2020 –
`present
`
`January 2018
`– April 2019
`
`November
`2015 – April
`2019
`
`July 2019 –
`June 2020
`
`Current position
`Interventional Cardiologist, VCU Health Pauley Heart Center, Richmond, VA, USA.
`Interventional cardiology faculty position within the Division of Cardiology of the Department of
`Internal Medicine.
`Director of Complex Coronary Interventions, VCU Health Pauley Heart Center, Rich-
`mond, VA, USA.
`I am developing and leading the complex percutaneous coronary intervention (PCI) program. My
`clinical expertise is centered on chronic total occlusion (CTO) PCI, ultra-low contrast volume PCI,
`and PCI with mechanical circulatory support, for all of which I designed and implemented protocols
`and quality monitoring initiatives.
`Associate Professor of Medicine (Cardiology), Virginia Commonwealth University,
`Richmond, VA, USA.
`I am leading several research projects in the field of complex PCI, particularly related to my fields
`of clinical expertise: CTO PCI, ultra-low contrast volume PCI, and PCI with mechanical circulatory
`support.
`Past appointments
`Co-Director, Chronic Total Occlusion Program, San Raffaele Hospital, Milan, Italy.
`I led the chronic total occlusion percutaneous coronary intervention program together with world
`expert Mauro Carlino.
`Consultant in Interventional Cardiology, San Raffaele Hospital, Milan, Italy.
`I was part of the group of interventionalists led by Dr. Antonio Colombo. I focused on complex and
`high-risk coronary interventions (in particular, chronic total occlusions). I also performed structural
`heart disease interventions (mainly TAVI).
`Education and Training
`Fellow in Interventional Cardiology (Research/Clinical), The Mount Sinai Hospital,
`New York, NY, USA.
`I was involved in the complex percutaneous coronary intervention program.
`research projects related to this subspecialty.
`
`I also led several
`
`EXHIBIT A
`
`

`

`November
`2013 –
`November
`2015
`
`November
`2012 – April
`2015
`
`November
`2008 – July
`2012
`
`May 2008 –
`May 2013
`
`March 2007 –
`April 2008
`
`August 2006 –
`February
`2007
`October 2000
`– July 2006
`
`Fellow in Interventional Cardiology, Montreal Heart Institute, Montreal, QC, Canada.
`After 6 months completely dedicated to clinical research, in which I designed and led several original
`studies in the field of coronary artery and structural heart disease, I trained in percutaneous coronary
`interventions and structural heart disease interventions for 18 months. During my senior year
`(2015), I served as Chief Fellow.
`PhD in Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
`My thesis is titled: ’Anatomic validation and clinical usefulness of multidetector computed tomo-
`graphy for the optimization of percutaneous treatment of severe aortic stenosis with transcatheter
`aortic valve implantation’. My work was supervised by Prof. Francesc Carreras, MD, PhD.
`MSc in Research Methodology: Design and Statistics in Health Sciences, Univer-
`sitat Autònoma de Barcelona, Barcelona, Spain.
`I have obtained a Master of Science degree in biostatistics and research methodology. The core
`curriculum encompasses the foundations of statistics applied to biomedical sciences, linear and
`logistic regression, Cox proportional hazards model, survival analysis, and their applications in
`experimental, cohort, case-control, and cross-sectional studies, and meta-analyses.
`Resident in Cardiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
`I
`Resident in Cardiology in a tertiary hospital in Barcelona, attending 1.5 million inhabitants.
`was exposed daily to complex patients with acute coronary syndrome and chronic ischemic heart
`disease, advanced acute and chronic heart failure, arrhythmias, valvulopathies, and heart transplant
`patients, either in clinical ward, emergency department, step-down unit and cardiac intensive care
`unit. During my senior year (2012-2013), I served as Chief Resident.
`Research Fellow, Centro de Investigación Biomédica en Red – Enfermedades Hepáticas
`y Digestivas (CIBERehd) & Institut D’Investigacions Biomèdiques August Pi i Sunyer
`(IDIBAPS), Barcelona, Spain.
`I worked in the Hepatic Fibrosis laboratory, under the supervision of Dr. Ramón Bataller, MD, PhD.
`I studied the effects of cigarette smoking as a potential predisposing factor for disease progression
`in obese rats with Non-Alcoholic Fatty Liver Disease (NAFLD).
`Senior House Officer, First Medical Division, Policlinico Universitario, Padua, Italy.
`I was responsible for daily ward rounds and I regularly took part in emergency room shifts.
`
`MD Degree, University of Padua Medical School, Padua, Italy.
`Grade: 110/110 cum laude
`Licenses
`2020 Virginia Board of Medicine, VA (USA) – Physician license #0101269046.
`Valid through September 30, 2022.
`2018 New York State Education Department, NY (USA) – Physician license #296137.
`Valid through August 31, 2021.
`2015 Ordine Provinciale dei Medici Chirurghi e degli Odontoiatri (OMCeO) di Milano,
`Italy – Physician license #44198.
`Valid through December 31, 2020.
`2013 Collège des Médecines du Québec (CMQ), QC (Canada) – Physician (limited) license
`#R19913.
`Registered between 2013 and 2016.
`2008 Col.legi Oficial de Metges de Barcelona (COMB), Spain – Physician license #43153.
`Registered between 2008 and 2013.
`Certifications
`
`EXHIBIT A
`
`

`

`2017 EAPCI Certificate of Excellence, European Association of Percutaneous Cardiovascular
`Interventions.
`I successfully undertook the EAPCI Learning Programme on the ESCeL platform and was awarded
`the EAPCI Certificate of Excellence on October 23, 2017.
`2016 MCCEE, Medical Council of Canada Evaluating Examination.
`MCCEE score: 316/pass. I passed the MCCEE on September 6, 2016.
`2013 ESC General Cardiology Exam, European Knowledge Assessment in Cardiovascular
`Medicine.
`Certified by the European Society of Cardiology.
`2013 USMLE Step 3, United States Medical Licensing Examination.
`Step 3 score: 225/pass (upon first attempt). I passed the USMLE Step 3 on February 12, 2013.
`2010 ECFMG certificate, United States Medical Licensing Examination.
`Step 1 score: 95/229 (upon first attempt). Step 2 CK score: 98/236 (upon first attempt). Step 2
`CS: pass (upon first attempt). I got my ECFMG certification on October 13th, 2010.
`2008 Spanish board (MIR) exam, Spanish board examination to apply for residency.
`Score: 98th percentile
`2007 Italian MD license, University of Padua Medical School, Padua, Italy.
`Awards & Grants
`(cid:123) Finalist at the 2018 Thomas J. Linnemeier Spirit of Interventional Cardiology Young
`Investigator Award.
`I was chosen as a finalist in this contest (sponsored by Cardio-
`vascular Research Foundation and presented during the Transcatheter Cardiovascular
`Therapeutics congress), which rewards the best clinician-scientists and leaders in the
`field of interventional cardiology. I was chosen as one of the four finalists after a selection
`of dozens of applications from all over the world.
`(cid:123) Top 4 abstracts at TCT 2016 (out of 1749 submissions): ‘Outcomes of chronic total
`occlusion percutaneous coronary intervention according to dissection/re-entry versus
`wire escalation techniques’.
`(cid:123) Top 8 abstracts at EuroPCR 2015 (out of 1183 submissions): ‘The benefits conferred
`by radial access for cardiac catheterisation are offset by a paradoxical increase in the
`rate of vascular access site complications with femoral access: the radial paradox’. My
`abstract was featured at the ‘PCR’s got talent!’ session.
`(cid:123) Montreal Live Symposium 2015 Fellow Poster Competition. Second prize.
`(cid:123) Society for Cardiovascular Angiography and Interventions (SCAI) Fall Fellows Course
`2014 Fellow Case Competition. First prize.
`(cid:123) Montreal Live Symposium 2014 Fellow Poster Competition. Third prize.
`(cid:123) Society of Cardiovascular Computed Tomography (SCCT) congress 2013, Montreal, QC,
`Canada: third prize at the SIEMENS Outstanding Academic Research (SOAR) Award.
`(cid:123) Radiological Society of North America (RSNA) congress 2013, Chicago, IL, USA:
`Certificate of merit.
`(cid:123) Spanish Society of Cardiology (SEC) 2013 grant for a one-year training period at the
`Montreal Heart Institute, Montreal, QC, Canada.
`(cid:123) European Association for the Study of the Liver (EASL) congress 2008, Milan, Italy:
`grant for young investigators.
`(cid:123) Rolf Olsson Symposium 2007, Gothenburg, Sweden: special prize for foreign invited
`speakers.
`
`EXHIBIT A
`
`

`

`2015 –
`present
`
`2015 –
`present
`
`2018 –
`present
`
`(cid:123) Sub-internship in Internal Medicine, Department of Medicine, Massachusetts General
`Hospital, Boston, MA, USA (2006): grade: honors.
`(cid:123) United European Gastroenterology Week (UEGW) congress 2006, Berlin, Germany:
`grant for young investigators.
`(cid:123) Harvard Medical School grant for foreign medical students (2005). Observership in
`Internal Medicine at the Department of Medicine, Massachusetts General Hospital,
`Boston, MA, USA.
`(cid:123) University of Padua Medical School special grant for elective clerkship in the USA (2005).
`(cid:123) Socrates-Erasmus exchange student (2005).
`I was chosen to spend my fifth year of
`medical school at the Universitat Autònoma de Barcelona, Barcelona, Spain, within the
`European Union Socrates-Erasmus Mobility Program.
`Research interests
`Chronic total occlusion (CTO).
`I have developed observational studies in the field of percutaneous revascularization of CTO. I
`am also interested in investigating new techniques to improve the efficacy and effectiveness of
`percutaneous revascularization of this challenging lesion subset.
`Contrast-induced acute kidney injury (CI-AKI).
`I am interested in developing risk prediction models for CI-AKI, as well as strategies to decrease
`the incidence of this condition.
`Complex percutaneous coronary intervention (PCI).
`I am interested in characterizing the outcomes of patients undergoing complex PCI as well as the
`technical aspects of specific devices and approaches used in complex PCI.
`Vascular access.
`I developed research projects on the outcomes and complications of radial and femoral access for
`cardiac catheterization and intervention.
`2014 – 2016 Bioresorbable scaffolds (BRS).
`I investigated on the incidence and mechanisms of BRS thrombosis in an all-comer patient
`population, and on the role of BRS in chronic total occlusions.
`Study leadership
`Zero-CI-AKI strategy, PI.
`Evaluation of the feasibility, safety and efficacy of an ultra-low-contrast-volume PCI strategy in
`patients with chronic kidney disease.
`2017 – 2018 Safety of ioversol during PCI, PI.
`Analysis of the safety of ioversol in comparison with other low-osmolar and iso-osmolar contrast
`media for PCI.
`2016 – 2018 REPEAT-FFR, Co-PI.
`Evaluation of the role of post-PCI fractional flow reserve (FFR) on decision-making to optimize
`patient outcomes.
`Peer–reviewed research articles
`Total number of publications: 147 (already indexed in PubMed: 144; in press: 3. Number of publications
`as first author: 73 (50% of total). h-index: 21.
`
`2014 –
`present
`
`2019 –
`present
`
`Original articles (n=71)
`(cid:123) Orlando R, Azzalini L, Orando S, Lirussi F. Bile acids for non-alcoholic fatty liver disease
`and/or steatohepatitis. Cochrane Database Syst Rev. 2020 Jul 9;7:CD005160.
`
`EXHIBIT A
`
`

`

`(cid:123) Moroni F, Spangaro A, Carlino M, Baber U, Brilakis ES, Azzalini L. Impact of renal
`function on the immediate and long-term outcomes of percutaneous recanalization of
`coronary chronic total occlusions: a systematic review and meta-analysis. Int J Cardiol.
`2020 May 25:S0167-5273(20)32041-6. doi: 10.1016/j.ijcard.2020.05.067. Online ahead
`of print.
`(cid:123) Azzalini L, Baber U, Johal GS, Farhan S, Barman N, Kapur V, Hasan C, Vijay P, Jhaveri
`V, Mehran R, Kini AS, Sharma SK. One-year outcomes of patients undergoing com-
`plex percutaneous coronary intervention with three contemporary drug-eluting stents.
`Catheter Cardiovasc Interv. 2020 Jun 1. doi: 10.1002/ccd.28996.
`(cid:123) Azzalini L, Alaswad K, Uretsky BF, Agostoni P, Galassi AR, Harada Ribeiro M, Filho
`EM, Morales-Victorino N, Attallah A, Gupta A, Zivelonghi C, Montorfano M, Bellini B,
`Carlino M. Multicenter experience with the antegrade fenestration and reentry technique
`for chronic total occlusion recanalization. Catheter Cardiovasc Interv. 2020 Apr 22. doi:
`10.1002/ccd.28941. [Epub ahead of print]
`(cid:123) Azzalini L, Johal GS, Baber U, Bander J, Moreno PR, Bazi L, Kapur V, Barman N, Kini
`AS, Sharma SK. Outcomes of Impella-supported high-risk nonemergent percutaneous
`coronary intervention in a large single-center registry. Catheter Cardiovasc Interv. 2020
`Apr 25. doi: 10.1002/ccd.28931.
`(cid:123) Pinto G, Fragasso G, Gemma M, Bertoldi L, Salerno A, Godino C, Colombo A, Azzalini L,
`Margonato A, Carlino M. Long-term clinical effects of recanalization of chronic coronary
`total occlusions in patients with left ventricular systolic dysfunction. Catheter Cardiovasc
`Interv. 2020 Mar 18. doi: 10.1002/ccd.28850. [Epub ahead of print]
`(cid:123) Ojeda S, Luque A, Pan M, Bellini B, Xenogiannis I, Lostalo A, Montorfano M, Hidalgo
`F, Venuti G, La Manna A, Carlino M, Brilakis E, Azzalini L. Percutaneous coronary
`intervention in aorto-ostial coronary chronic total occlusion: outcomes and technical
`considerations in a multicenter registry. Rev Esp Cardiol (Engl Ed). 2020 Mar 4. pii:
`S1885-5857(20)30037-2. doi: 10.1016/j.rec.2020.01.008. [Epub ahead of print]
`(cid:123) Demir OM, Poletti E, Lombardo F, Beneduce A, Maccagni D, Cappelletti A, Colombo
`A, Bellini B, Ancona MB, Carlino M, Chieffo A, Montorfano M, Azzalini L. Rotational
`atherectomy-based percutaneous coronary intervention and the risk of contrast-induced
`nephropathy. Minerva Cardioangiol. 2020 Feb 25. doi: 10.23736/S0026-4725.20.05