UNITED STATES PATENT AND TRADEMARK OFFICE
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`__________________
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________________
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`MEDTRONIC, INC.
`Petitioner
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`v.
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`NUVASIVE, INC.
`Patent Owner
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`
`
`Case IPR2014-00087
`U.S. Patent 8,005,535
`
`__________________
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`
`
`DECLARATION OF PATRICK MILES
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`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-145
`
`1
`
`NUVASIVE 2024
`Medtronic v. NuVasive
`IPR2014-00087
`
`
`
`__________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________
`
`
`
`MEDTRONIC, INC.
`Petitioner
`
`v.
`
`NUVASIVE, INC.
`Patent Owner
`
`
`
`Case IPR2014-00087
`U.S. Patent 8,005,535
`
`__________________
`
`
`
`DECLARATION OF PATRICK MILES
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-145
`
`1
`
`NUVASIVE 2024
`Medtronic v. NuVasive
`IPR2014-00087
`
`
`
`
`
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`
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`TABLE OF CONTENTS
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`TABLE OF CONTENTS
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`I.
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`BACKGROUND ............................................................................................................. ..1
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`II. OBJECTIVE INDICIA OF NON—OBVIOUSNESS .......................................................... .. 2
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`III. THE PATENT CLAIMS AND XLIF ................................................................................. .. 3
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`IV.
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`INVENTION HISTORY .................................................................................................. .. 4
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`I. BACKGROUND ............................................................................................................... 1
`II. OBJECTIVE INDICIA OF NON-OBVIOUSNESS ............................................................ 2
`III. THE PATENT CLAIMS AND XLIF ................................................................................... 3
`IV. INVENTION HISTORY .................................................................................................... 4
`V.
`INITIAL SKEPTICISM ...................................................................................................... 6
`VI. PRAISE AND ACCEPTANCE BY OTHERS .................................................................... 8
`VII. XLIF COMMERCIAL SUCCESS ................................................................................... 20
`VIII. COMPETITORS’ COPYCAT LATERAL SYSTEMS ...................................................... 28
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`V.
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`INITIAL SKEPTICISM .................................................................................................... .. 6
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`VI. PRAISE AND ACCEPTANCE BY OTHERS .................................................................. .. 8
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`VII. XLIF COMMERCIAL SUCCESS ................................................................................. .. 20
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`VIII. COMPETITORS’ COPYCAT LATERAL SYSTEMS .................................................... .. 28
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`i
`1
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`2
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`Attorney's Docket No.: 13958-0055007 / 023US8
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`I, Patrick Miles of San Diego, California, hereby declare that:
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`
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`I.
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`1.
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`BACKGROUND
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`I am currently President of Global Products and Services at NuVasive, Inc.
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`(the Patent Owner), in San Diego, California. I have worked at NuVasive since January of
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`2001. Prior to my current position, I served as President of the Americas from January
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`2010 to October 2011, Executive Vice President of Product Marketing and Development
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`from January 2007 to December 2009, Senior Vice President of Marketing from December
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`2004 to January 2007, and Vice President of Marketing from January 2001 to December
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`2004.
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`2.
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`Prior to starting with NuVasive in 2001, I worked for ORATEC from 1999
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`through 2001. ORATEC is a medical device company outside the spinal field. From 1996
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`through April 1999, I worked at Sofamor Danek (which was acquired by Medtronic in 1998,
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`becoming Medtronic Sofamor Danek) as Director of Marketing for Minimally Invasive
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`Systems and Cervical Spine Systems.
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`3.
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`Throughout my time at NuVasive, I have been involved at varying levels with
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`the research, development, and marketing of NuVasive’s eXtreme Lateral Interbody Fusion
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`(“XLIF”) systems and procedure. I started working on the XLIF products and systems in
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`2001. I was involved with the launch of the XLIF procedure and products at the North
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`American Spine Society (“NASS”) meeting in October 2003. I have been involved in the
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`commercialization and development of XLIF and its associated products since its inception.
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`I am currently listed as an inventor on 51 issued U.S. patents assigned to NuVasive, many
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`of which relate to NuVasive’s XLIF procedure and systems. I am one of the listed inventors
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`on U.S. Patent Nos. 8,005,535 (“the ’535 patent”), 8,000,782 (“the ’782 patent”), 8,016,767
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`(“the ’767 patent”), and 8,192,356 (“the ’356 patent”), which are the subject of the instant
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`inter partes reviews.
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`
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`II.
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`4.
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`OBJECTIVE INDICIA OF NON-OBVIOUSNESS
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`I am not offering an opinion regarding whether the ’535, ’782, ’767, and/or
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`’356 patents are obvious in light of the prior art raised by Medtronic in the inter partes review
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`proceedings, which I understand turn on legal determinations that I have not been asked to
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`address. It is my understanding, however, that the existence of one or more so-called
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`“secondary considerations” or “objective indicia” of non-obviousness must be considered in
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`determining whether a patent is obvious in light of prior art. I understand these objective
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`indicia include:
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`a. commercial success of a product due to the merits of the claimed
`invention;
`b. a long felt need for the solution provided by the claimed invention;
`c. unsuccessful attempts by others to find the solution provided by the
`claimed invention;
`d. copying of the claimed invention by others;
`e. unexpected and superior results from the claimed invention;
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`f. acceptance by others of the claimed invention as shown by praise
`from others in the field or from the licensing of the claimed invention;
`g. teaching away from the conventional wisdom in the art at the time of
`the invention;
`h. other evidence tending to show non-obviousness; and
`i. other evidence tending to show obviousness.
`It is my understanding that, in order to establish objective indicia of
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`5.
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`nonobviousness, NuVasive must show a nexus between the claims of the patent and the
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`objective indicia such as commercial success of an embodiment of that patent. In the
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`context of commercial success, for example, I understand this means the commercial
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`success of XLIF as an embodiment of the ’535, ’782, ’767, and/or ’356 patents must be tied
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`to the claims of the ’535, ’782, ’767, and/or ’356 patents. Below I discuss facts that I am
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`aware of and documents that I have reviewed that support what I understand to be relevant
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`objective indicia. To reiterate, however, I am providing only factual testimony pertinent to
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`secondary considerations of non-obviousness and am not expressing any expert opinion on
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`the validity of the claims or whether any surgical methods or tools practice those claims.
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`
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`III.
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`6.
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`THE PATENT CLAIMS AND XLIF
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`I have reviewed the analysis of Dr. Frank Phillips matching the independent
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`claims of the ’535, ’782, ’767, and ’356 patents to the XLIF procedure and/or systems, and I
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`rely on his analysis in my discussion below. [Ex. 2020 (Phillips Decl.) at ¶¶ 22-27,
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`Attachments B-E.]
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`IV.
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`7.
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`INVENTION HISTORY
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`
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`NuVasive was founded in 1999 and started, basically, in the garage of the
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`
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`founder, Dr. James Marino. It was built from the ground up over the years into what is now
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`one of the leading medical device companies for minimally disruptive surgical products and
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`procedures for the spine. When I joined NuVasive in 2001, before these inventions and
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`before XLIF, it was a tiny company in the middle of a research and development effort that
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`would eventually propel NuVasive to the forefront of minimally invasive spine surgery.
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`8.
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`In the early 2000’s, NuVasive was primarily focused on creating better
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`equipment and procedures for treating degenerative disc disease in the lumbar and thoracic
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`spine. Prior to this time, there were a variety of procedures on the market for performing
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`discectomies and vertebral fusions, each with associated risks and disadvantages. The
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`most common approaches to the lumbar spine were the posterior (from the back) and the
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`anterior (from the abdomen) approaches. Dr. Phillips explains this in detail, but I know this
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`to be true also from my own experience in the spinal industry, including (beginning in 1994),
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`extensive personal interactions with spine surgeons, and extensive personal observations in
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`the operating room.
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`9.
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`Starting in 2001, NuVasive began the development of a procedure and
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`systems designed to solve the problem of nerve damage in lateral access procedures.
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`NuVasive ultimately called the new procedure XLIF. To my knowledge, and as reflected in
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`the literature, NuVasive was the first company to provide a minimally invasive lateral
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`4
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`6
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`transpsoas approach to the lumbar spine using nerve monitoring. [Ex. 2030 at S370 (“In the
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`early 21st Century, a modification of the approach, with real-time, directionally stimulated,
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`discrete threshold EMG IOM was developed to aid in the identification of intrapsoas nerves.
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`The addition of EMG has allowed the surgeon to be able to determine the location
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`(proximity) of and avoid intrapsoas nerves during the approach. … This minimally invasive
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`approach, extreme lateral interbody fusion (XLIF, NuVasive, Inc., San Diego, CA) using
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`EMG IOM (NeuroVision NuVasive, Inc.) approaches the spine with sequential dilators
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`orthogonal to the disc space in a true lateral position which stimulate (tEMG) directionally
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`and provide discrete threshold results of lower limb nerve root function (bilateral vastus
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`medialis, tibialis anterior, biceps femoris, and medial gastrocnemius myotomes) while
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`passing through and when positioned within the psoas muscle.”)]
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`10. NuVasive expended substantial capital and human resources in developing
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`its innovations and in the commercialization of XLIF. I estimate that NuVasive spent
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`between $20,000,000 and $30,000,000 on the initial development of NuVasive’s XLIF
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`solution from the middle of 2001 to the fall of 2004. We discovered that an operative
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`corridor could be safely and reproducibly created through a patient using a nerve monitoring
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`enabled distractor/dilator and a retractor (that was also optionally nerve monitoring
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`enabled), both passing along a lateral path through the psoas, and monitoring depolarized
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`nerves during the access procedure. By stimulating the electrodes and sensing responses
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`of depolarized nerves, we could determine the relative distance to nearby nerves and
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`communicate that information to a user in fractions of a second. The XLIF technology allows
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`surgeons to identify nerves in the surgical path during the access procedure before coming
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`into contact with them, preventing damage to the nerve roots and allowing the surgeon to
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`select a different, safer path if necessary. [See e.g., Ex. 1017 of IPR2014-00034 (’782
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`Patent) at Col. 9:19-28; Ex. 1015 of IPR2014-00087 (’535 Patent) at Col. 9:24-32.]
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`NuVasive also further refined the procedure and instruments by developing dilators that had
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`an electrode on only a portion of the distal end, which allowed surgeons to determine the
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`relative direction of nearby nerve tissue, further improving navigation through the psoas.
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`[See e.g., the ’782 patent, Col. 25:4-29.]
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`11. Unfortunately, the industry was not quick to believe that the psoas muscle
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`could really be crossed safely by a spine surgeon of ordinary skill.
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`V.
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`12.
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`INITIAL SKEPTICISM
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`The XLIF procedure was released at the North American Spine Society
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`Annual (“NASS”) Meeting in October 2003 and marketing continued into 2004. Initially,
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`NuVasive’s XLIF solution was met with substantial skepticism from the majority of the spine
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`surgeon community. We received instant and repeated push back from surgeons who just
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`did not believe that it was safe. After XLIF’s launch in October 2003, and through 2007, I
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`personally heard from many surgeons who did not believe that the XLIF procedure and
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`systems could safely traverse the psoas muscle to reach the lumbar spine from a lateral
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`approach. For example, I recall speaking with Dr. Maurice Smith (a consultant to Medtronic
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`who is also an inventor on patents that I understand are at issue in these proceedings)
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`following XLIF’s launch, who expressed that he did not believe XLIF would gain wide
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`acceptance among spine surgeons because of the difficulties of traversing the psoas
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`muscle and of navigating the retroperitoneal space blindly to arrive at the correct target site
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`on the spine. From my conversations with him, it appeared that Dr. Smith did not believe
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`that NuVasive’s minimally invasive access system with nerve monitoring would work safely
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`and reproducibly.
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`13.
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`The literature around the time of XLIF’s launch reflects the skepticism
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`associated with traversing the psoas at that time. For example, an article by Dr. Hallett
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`Mathews in 2003 explained the view that by 2003 surgeons recognized advantages to
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`dissecting the psoas muscle yet “have not felt comfortable with dissecting the psoas
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`because of the presence of the lumbar plexus.” Ex. 2046 (Matthews, “Point of View”
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`SPINE Vol. 28 (2003)) at 428.] In addition, NuVasive’s own marketing research (performed
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`in conjunction with surgeons) showed that as late as 2009, lingering skeptics were still
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`concerned about “the perceived complications associated with XLIF (e.g., psoas
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`pain/weakness, dysthesias, numbness, and quad weakness).” [Ex. 2031 at 3.]
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`14. During those early years, NuVasive put substantial resources into educating
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`the spinal community to overcome that skepticism and show that XLIF was indeed a safe
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`and effective solution for spinal fusion, especially in the lower lumbar region. This included
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`having untrained, skeptical surgeons visit the operating rooms of some early adopters of
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`XLIF, including Dr. Luiz Pimenta in Brazil. There, the surgeons were able to see first-hand
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`how NuVasive’s NeuroVision system alerted surgeons to the presence of nerves in the
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`psoas before ever coming into contact with them, and how the surgeon could avoid the
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`nerve roots and thus avoid neurologic injury while creating an operative corridor from a
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`lateral transpsoas approach. That helped to give them the confidence in NuVasive’s nerve
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`monitoring technology to then try XLIF in their own operating rooms.
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`15. Over time, the number of surgeons performing XLIF grew. [See Ex. 2089 at 1
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`(“When Tohmeh started performing the minimally invasive [XLIF] fusion procedure here in
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`2004, he says he was one of only 20 surgeons in the U.S. doing the surgery. Now,
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`hundreds of surgeons in the U.S. are performing such procedures on thousands of patients
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`across the country, he says.”)] More and more peer-reviewed articles were published
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`regarding the XLIF procedure and its successes. [See e.g., 2030, 2032, 2043, 2055.]
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`Surgeons began attending training sessions in greater numbers to learn first-hand that the
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`XLIF procedure actually could traverse the psoas muscle safely and reproducibly.
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`VI.
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`16.
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`PRAISE AND ACCEPTANCE BY OTHERS
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`Through NuVasive’s education efforts, surgeons began adopting XLIF into
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`their practices at an ever-increasing rate, and saw improved patient outcomes. I personally
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`saw the sea-change in attitude in a variety of ways, including through the growth of our
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`business, through the interest at industry meetings, through the number of surgeons
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`contacting us for training on XLIF over the years, and through publications regarding XLIF’s
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`revolutionary approach. Indeed, surgeons, on their own, began to extoll the benefits of
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`NuVasive’s XLIF procedure and systems both in personal statements and in peer-reviewed
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`publications. Following are quotes from some of the plethora of statements and
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`publications that spine surgeons have made regarding XLIF:
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` XLIF is performed through a lateral, retroperitoneal, transpsoas approach to the
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`anterior column, and uses real-time directional neuromonitoring to ensure a
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`safe passage through the psoas muscle, avoiding the nerves of the lumbar
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`plexus. The benefits of the lateral approach used in XLIF, compared with
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`anterior and posterior approaches, include the avoidance of vascular, visceral,
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`and sexual dysfunction complications sometimes experienced in open anterior
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`procedures, and paraspinal denervation, dural tear, and neural injuries in
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`posterior approaches, while also allowing for a broad discectomy and placement
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`of a large footprint graft. Additionally, the anterior and posterior longitudinal
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`ligaments remain intact, providing inherent stability during the formation of bone
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`in fusion. [Ex. 2030 at S303 (emphasis added).]
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` Since the introduction of the XLIF technique to North America in late 2003, a host
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`of advantages for our patients have become apparent:
`o Less tissue damage leads to quicker recovery and decreased narcotic
`requirements;
`o It is widely applicable to a host of degenerative spinal conditions;
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`o It is safe and reproducible with few complications due to the use of
`automated neuromonitoring (NeuroVision®);
`o The large load-bearing interbody construction provides disc space
`distraction, indirect decompression, sagittal alignment correction, and
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`stability; and
`o Improved efficiency resulting in shorter operating room (OR) time and
`decreased length of stay. [Ex. 2043 at 28 (emphasis added).]
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` A report from 2004 of the use of the lateral transpsoas approach without this type
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`of IOM [NuVasive’s NeuroVision] found postoperative paresthesia rates as high
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`as 30%. In the largest series reported to date using the approach with this
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`monitoring [NuVasive’s NeuroVision], Rodgers et al. showed a 0.7% neural injury
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`rate (3 quadriceps femoris weakness, 1 tibialis anterior weakness) which all
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`resolved by 3 months postoperative in 600 consecutively treated XLIF patients.
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`[Ex. 2030 at S370.]
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` In addition to knowledge of the anatomy and image guidance, directional EMG
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`IOM is crucial for safe passage through the psoas muscle. [Ex. 2030 at S372.]
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` In summary, this study suggests that although in a majority of lateral transpsoas
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`interbody surgeries, the intrapsoas nerves are a safe distance from the disc
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`access pathway, the anatomic variations in location of these nervous tissue place
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`them at risk of injury in a small number of cases. In particular, surgeons should
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`be cognizant of the higher risk of nerve injury at lower levels, especially at L4-5.
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`To reduce this risk, real time neuromonitoring may be an important element
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`of this procedure. [Ex. 2052 at 227 (emphasis added).]
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` Real-time monitoring using the NeuroVision System does help minimize the risk
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`of injury by providing reliable, real-time information about the proximity and
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`directionality of the lumbosacral plexus during the transpsoas approach, as
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`demonstrated by the 97% of cases where no neural injury occurred; this is
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`despite the fact that 90% of the approaches targeted the posterior half of the disc
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`space. Dynamic, discrete-thrshold EMG is an integral and necessary part of
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`the XLIF procedure. [Ex. 2053 at 6 (emphasis added).]
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` Overall, the lateral approach to the anterior column reconstruction appears to
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`have some advantages compared with traditional anterior and posterior
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`approaches to the lumbar spine: the XLIF approach does not require a general
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`access surgeon, does not retract or violate the peritoneum, eliminates the need
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`for mobilization of the great vessels and preserves the anterior and posterior
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`longitudinal ligaments. The lateral approach is susceptible to risks similar to any
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`spine surgery, but the incidence of these events is reportedly low and within the
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`acceptable range of literature-reported complications following traditional spine
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`surgery procedures. In fact, some of these risks such as postoperative medical
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`issues and infection appear to be minimized with the use of a minimally invasive
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`procedure compared with traditional open procedures, presumably due to the use
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`of smaller incisions and the minimal disruption of surrounding anatomy. [Ex.
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`2030 at S309 (emphasis added).]
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` During the preoperative portion of the [XLIF] procedure, adhesive electrodes –
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`part of the nerve monitoring system developed by NuVasive called NeuroVision
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`JJB – are placed on the skin overlying the patient’s leg muscles. The electrodes
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`track muscle activity during the procedure and provide information about the
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`spinal nerves that cause the muscle activity. That information helps surgeons
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`locate and avoid the nerves during the surgery and thus prevent nerve damages.
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`… The XLIF method causes less blood loss and scarring than open-spine
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`surgery, which helps to reduce recovery times to about six weeks, compared with
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`the six month recovery time for open-spine surgery, Tohmeh says. Patients only
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`have to stay at the hospital overnight, whereas open-spine surgery requires a
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`hospital stay of several days, and postoperative pain is reduced with the XLIF
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`procedure, he says. … Adults of all ages can have the XLIF surgery, which is an
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`important factor because open-spine surgery can be especially dangerous for
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`elderly patients, he says. [Ex. 2089.]
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` XLIF provides relief to patients who cannot tolerate larger, open back surgery
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`due to increased risks of longer anesthesia time, blood loss, hospitalization, and
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`recovery. It is also a less invasive alternative for patients who have lived with
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`back or leg pain through years of various failed treatments, including steroid
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`injections, physical therapy, and pain medication. XLIF is made safe with the
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`use of NeuroVision, a technologically advanced nerve monitoring system
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`(EMG), that provides the surgeon with accurate, reproducible, real-time
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`feedback about nerve health, location, and function, reducing the incidence
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`of nerve injury during surgery. [Ex. 2090 (emphasis added).]
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` The [XLIF] surgery is performed with the patient laying on his or her side. X-ray
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`taken in surgery precisely identify the area to be operated on and special nerve
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`monitors are passed in through small incisions, thus protecting the
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`delicate nerves and making the procedure safe. The small incision are
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`made to help guide the nerve-monitoring system, which is what allows the
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`procedure to have a quicker recovery time. Patients are usually in the
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`hospital overnight and are back to most activities within four to six weeks after
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`surgery, Rodgers said. [Ex. 2088 at 1 (emphasis added).]
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` ‘I was amazed. I was in one day and out the next,’ said Elliott [the patient], who
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`had experienced the slow and painful aftermath of a traditional ‘open’ spine
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`fusion surgery four years before. ‘In just a few days, I’d already regained the
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`flexibility and mobility that took six to eight weeks before.’ The procedure was
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`performed by Burak Ozgur, M.D., a neurosurgeon at the Cedars-Sinai Institute
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`for Spinal Disorders, who has extensive experience with this procedure, called
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`XLIF (Extreme Lateral Interbody Fusion), and other minimally invasive spine
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`surgery techniques. ‘While the major advantage of minimally invasive spinal
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`fusion is quick recovery, there are many other benefits,’ points out Ozgur, who
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`said the techniques can also be used in cases such as adult degenerative
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`scoliosis. ‘There is less pain and scarring because smaller incisions mean less
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`tissue and muscle are damaged. There is a lower risk of infection and surgical
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`complications, and a blood transfusion is rarely if ever needed. … The
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`introduction of minimally invasive procedures is a remarkable turning point and
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`revolution in spine surgery,” said Ozgur, who estimates that 90 percent of spinal
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`surgery patients, whether needing decompression or fusion of the spine, may be
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`potential candidates for a minimally invasive approach. ‘It’s also ideal for older
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`patients who couldn’t tolerate a long surgery or potential blood loss.’ … Ozgur
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`performed the spinal fusion surgery through two small incisions ‘each just an
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`inch-and-a-half’ that were closed with melt away stiches and glue, which
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`minimize scarring. The operation took about 45 minutes of actual surgical time
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`“less than half the time of traditional spinal fusion surgery” and Elliott was up and
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`walking less than three hours after the operation. [Ex. 2033 at 1-2 (emphasis
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`added).]
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` Ozgur said the procedure, which was completed in about three and a half hours,
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`is performed in two steps. “First, we approach from the side, exactly 90 degrees
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`from the spine, and access the two disk spaces. We remove the disks and put in
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`‘cages’ that contain bone graft materials and a protein that enhances and speeds
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`up the fusion process. Then from the back, we insert screws and rods to stabilize
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`the spine.” … Weber was discharged from the hospital after three days and
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`stayed with family in the Los Angeles area. Her mother then returned with her
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`home and stayed about three weeks for support. “I cannot believe how good I felt
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`right afterward. I went Christmas shopping. My mom had to make me slow
`
`down,” said Weber, noting that without constant pain she has more energy and
`
`feels “full of life.” Although she has to pace herself for a while, she expects to
`
`gradually resume her normal routine. “I think this procedure is revolutionizing
`
`spinal fusions because it’s changing how people are recovering,” Ozgur
`
`said. “Compared to invasive surgery, the end result looks the same as far as the
`
`construct, but the recovery is much improved. And it can be an option for other
`
`indications, such as adult degenerative scoliosis, which is usually more
`
`complicated and involving more levels. I’ve done five- and six-level cases with
`
`this type of approach.” [Ex. 2036 at 2 (emphasis added); see also Ex. 2032.]
`
` XLIF is a revolutionary technique that lowers the risk of complications normally
`
`associated with spine surgery. Only for those vertebrae of the spine that have
`
`clear access from the side of the body, this technique typically allows a shorter
`
`hospital stay and may be less painful than traditional approaches to the spine
`
`15
`
`
`17
`
`
`
`
`
`
`
`
`allowing a more rapid recovery and return to activity. Dr. Steiber has undergone
`
`
`
`advanced training in this technique and is on the leading edge of the use of this
`
`special minimally-invasive procedure. [Ex. 2035 at 3 (emphasis added).]
`
` XLIF technology is revolutionizing the care of patients needing
`
`thoracolumbar spinal fusion surgery between T6-7 and L4-5. More rapid
`
`recovery is facilitated by decreased tissue trauma. [Ex. 2043 at 32 (emphasis
`
`added).]
`
`17. Other publications underscore the way the XLIF procedure and instruments
`
`have changed spine surgery, emphasizing the importance of incorporating neuromonitoring
`
`into the XLIF system and procedure. For example, a paper by Thomas Weisel Partners
`
`titled “Bending the Paradigm” credits NuVasive with “Pioneering” the MIS fusion market,
`
`noting that “Surgeon feedback is overwhelmingly positive,” and stating that it is “NuVasive’s
`
`neuromonitoring platform and specialized instrumentation” that makes the XLIF procedure
`
`viable. [Ex. 2047 at 12, 58.] Also, the article by Dr. Rodgers addresses the relative
`
`importance of nerve monitoring during the procedure, stating: “It is impossible to
`
`overemphasize the importance of reliable, timely monitoring of the neural elements as the
`
`surgeon traverses the psoas.” [Ex. 2043 at 28, 32.] Another article discussing the XLIF
`
`procedure stated that it “changed the lateral approach from an open procedure to minimally
`
`invasive” and states that the “breakthrough equipment and instruments” allow surgeons to
`
`“electronically detect nerves in real-time, overcoming a major obstacle to the lateral
`
`16
`
`
`18
`
`
`
`
`
`
`
`approach and making the procedure easily reproducible.” [Ex. 2048 (Ehrhardt, "Lateral
`
`
`
`Interbody Fusion Training Comes to Birmingham," Birmingham Medical News) at 1.] One
`
`clinical study that praises the benefits of the XLIF procedure also warns that “strict
`
`adherence to the surgical technique including neuromonitoring is essential.” [Ex. 2055 at 1,
`
`see also 5; see also Ex. 2088 at 1.] All of these articles and studies stressing the
`
`importance of neuromonitoring are consistent with NuVasive’s own research and feedback
`
`from surgeons. XLIF’s success is directly related to the innovative procedure and
`
`instruments that combine a minimally invasive nerve monitoring enabled distraction
`
`assembly and a retraction assembly (that is also optionally nerve monitoring enabled) with a
`
`nerve monitoring system to safely and reproducibly navigate the psoas muscle, avoiding the
`
`nerve roots, and reaching the target disc space. Without the ability to safely traverse the
`
`nerve-rich psoas muscle, XLIF would not have been safe, XLIF would not have been
`
`accepted by the surgical community, and XLIF would certainly not have received such
`
`praise for being so beneficial and revolutionary.
`
`18.
`
`The benefits of XLIF were part of the subject of the testimony of Dr. William
`
`Smith in Warsaw v. NuVasive, Case No. 08-CV-1512, tried in district court in 2011. I
`
`personally attended and testified in that trial. There, Dr. Smith discussed the benefits that
`
`XLIF has brought to his practice, including being able to treat patients that he would not be
`
`able to otherwise treat with the surgical options available prior to the introduction of XLIF.
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`[Ex. 2034 at 1402-1407.] Another article credits NuVasive with developing the XLIF
`
`17
`
`
`19
`
`
`
`
`
`
`
`procedure, and praises the technique with “glowing testimonials” of cases of “huge success”
`
`
`
`when “[t]raditional surgery was out of the question.” [Ex. 2054 at 1-2.]
`
`19.
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`Patients themselves have told us about the incredible results they have
`
`experienced from having had an XLIF procedure for lumbar fusion:
`
` The time waiting for my operation had passed quickly, and now even my surgery
`
`was finally behind me. The only thing left was my recovery, and I was ready to
`
`get started. I spent the first few days in the hospital expecting to “do time” and
`
`allow my body to heal. But, remarkably, within twenty-four hours I was up and
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`walking. Within just a few days, I was released from the hospital and able to
`
`climb stairs. I almost couldn’t believe it. And get this: just two-and-half weeks
`
`after having the XLIF procedure, I was doing a day hike up Mount Charleston
`
`near Las Vegas. It was a three-mile round trip outing, and I felt like a man just
`
`released from prison with his whole life ahead of him. Within three months after
`
`having spine surgery, I was back in the gym training again. [Ex. 2037 at 10.]
`
`20.
`
`There are many other stories of patients who have benefited from the XLIF
`
`procedure and systems, many of which have been documented in writing [See e.g., Ex.
`
`2037; see also Ex. 2033; Ex. 2087], and countless others we have heard only orally.
`
`21.
`
`Even industry publications described the benefits of the XLIF procedure and
`
`systems:
`
`18
`
`
`20
`
`
`
`
`
`
`
` When compared to traditional spine procedures that approach patients from the
`
`
`
`
`
`back or front and take many hours to complete, the XLIF® procedure may be
`
`successfully completed in as little as one hour, reducing the length of time that
`
`the patient must be anesthetized. Because the procedure does not require entry
`
`through the sensitive back muscles, bones or ligaments, many patients are able
`
`to walk the day after surgery. Patients who undergo an XLIF procedure typically
`
`require only an overnight hospital stay and generally complete their recovery in
`
`approximately six weeks. Patients who undergo traditional procedures may
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`experience several days of immobility and may require six months or more to
`
`fully recover. [Ex. 2041 at 24-25.]
`
` Minimally invasive (MIS) lateral interbody fusion (LIF) through a retroperitoneal
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`transpsoas approach has become increasingly popular as a less invasive
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`treatment of degenerative spinal disease, deformity, and trauma. It offers several
`
`potential advantages over traditional posterior approaches to interbody
`
`fusion, including decreased muscle dissection, decreased post-operative muscle
`
`atrophy, and the abi
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