Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 1 of 7
`
`James J. Elacqua (CBS No. 187897)
`james.elacqua@dechert.com
`Noemi C. Espinosa (CBS No. 116753)
`nicky.espinosa@dechert.com
`Andrew N. Thomases (CBS No. 177339)
`andrew.thomases@dechert.com
`Michelle W. Yang (CBS No. 215199)
`michelle.yang@dechert.com
`Hieu H. Phan (CBS No. 218216)
`hieu.phan@dechert.com
`DECHERT LLP
`2440 West El Camino Real, Suite 700
`Mountain View, California 94040
`Telephone: (650) 813-4800
`Facsimile: (650) 813-4848
`Attorneys for Plaintiff
`MEDTRONIC, INC., MEDTRONIC USA, INC.,
`AND MEDTRONIC VASCULAR, INC.
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN FRANCISCO DIVISION
`
`MEDTRONIC, INC., a Minnesota
`corporation, MEDTRONIC USA, INC., a
`Minnesota corporation, and MEDTRONIC
`VASCULAR, INC., a Delaware
`corporation,
`
`Plaintiff,
`
`v.
`AGA MEDICAL CORPORATION, a
`Minnesota corporation,
`Defendant.
`
`Case No. C07 00567 MMC
`DECLARATION OF DR.
`CHRISTOPHER K. ZARINS, M.D.
`IN SUPPORT OF PLAINTIFFS’
`OPPOSITION TO DEFENDANT’S
`MOTION FOR SUMMARY
`JUDGMENT
`Date:
`April 3, 2009
`Time:
`9:00 AM
`Courtroom 7, 19th Floor
`Place:
`Judge: Hon. Maxine M. Chesney
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`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
`CASE NO. C07-00567 MMC
`
`Medtronic Exhibit 2003
`Cook v. Medtronic
`IPR2019-00123
`Page 00001
`
`

`

`Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 2 of 7
`
`
`I, Dr. Christopher K. Zarins, declare:
`
`1.
`
`I make the following statements in this declaration based on my personal knowledge of
`
`the facts stated herein, and if called upon to testify, I could testify competently as to such matters.
`
`2.
`
`3.
`
`I have been retained by Medtronic, Inc. as an expert in the above-captioned matter.
`
`I am a vascular surgeon at Stanford University Medical Center as well as a Professor at
`
`the Stanford University School of Medicine, Department of Surgery. I was the Chief of Vascular
`
`Surgery at Stanford from 1993-2005. Prior to Stanford University, I was the Chief of Vascular
`
`Surgery at the University of Chicago, Medical Center from 1976 to 1993. My employment and
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`educational history are detailed in my CV, attached at Exhibit 1.
`
`4.
`
`A list of publications on endovascular procedures and research and editorial boards I have
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`sat on are listed at Exhibit 1.
`
`5.
`
`I am a named inventor on six patents related to intravascular procedures. The list of my
`
`issued patents is attached at Exhibit 2.
`
`6.
`
`I have been performing endovascular procedures since 1978, which includes implanting
`
`self-expanding medical devices for the treatment of aneurysms. I also have performed open
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`surgical procedures for repair of aortic aneurysms. I am currently a practicing cardiovascular
`
`surgeon.
`
`7.
`
`I am personally familiar with and have personally implanted into patients a variety of self-
`
`expanding medical devices made from shape memory alloys, including Medtronic’s AneuRx and
`
`TALENT devices. I have also implanted Gore’s EXCLUDER, TAG and VIABAHN devices as
`
`well as AGA’s Vascular Plug devices.
`
`8.
`
`In the course of my professional activities, I have become familiar with medical devices
`
`used for treating cardiovascular disease, and am aware of evolving and current best practices used
`
`in endovascular procedures to implant self-expanding medical devices.
`
`A.
`
`RETENTION IN CASE
`
`9.
`
`I am being compensated at a rate of $3,500 per full 8-hour day (partial days to be pro-
`
`rated) for my work on this case.
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`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
` CASE NO. C07-00567 MMC
`
`IPR2019-00123 Page 00002
`
`

`

`Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 3 of 7
`
`
`SCOPE OF OPINIONS
`
`B.
`In this declaration, I address the need for, and commercial success of self-expanding shape
`
`10.
`
`memory devices used in endovascular procedures used in lieu of open surgical techniques.
`C. MATERIALS CONSIDERED
`In forming the opinions set forth in this declaration, I have relied upon my personal
`
`11.
`
`education, training, background and extensive professional experience performing endovascular
`
`procedures.
`12.
`
`I am familiar with the Instructions for Use (“IFU”) for the AneuRx, Talent, EXCLUDER,
`
`TAG, VIABAHN, VIABIL, VIATORR, HELEX products. I am also familiar with the IFU for
`
`AGA’s Vascular Plug products. See, http://www.goremedical.com and
`
`http://www.amplatzer.com/.
`13.
`
`In forming my opinions, I have also reviewed the Jervis Patents being asserted against
`
`AGA Medical Corporation (“AGA”), U.S. Patent Nos. 5,067,957 (“‘957 Patent”), 5,190,546
`
`(“‘546 Patent”), and 6,304,141 (“‘141 Patent”) (collectively, the “patents-in-suit”).
`14.
`
`In the event of a trial in this matter, in connection with my testimony, I may also rely upon
`
`Exhibit 3, as well as demonstrative exhibits, Medtronic and AGA’s expert reports, and the trial
`
`testimony and trial exhibits of Medtronic and/or AGA’s witnesses.
`D.
`I understand that the patent law regarding secondary considerations or indicia of non-
`
`SECONDARY INDICIA OF NON-OBVIOUSNESS
`
`15.
`
`obviousness can include, among other things, factors such as (1) a long felt need for the solution
`
`provided by the claimed invention; (2) the commercial success of a product covered by the patent;
`
`and (3) acceptance by others of the claimed invention in the industry.
`II.
`16.
`
`BACKGROUND FOR THE JERVIS PATENTS’ TECHNOLOGY
`
`Before self-expanding stent devices were available, open surgery and its attendant risks
`
`were used to treat aneurysms. Open surgery involves greater risks to the patient of infection due
`
`to the larger incisions made into the body, and the trauma and invasiveness of open surgery.
`
`Open surgical techniques involve longer periods of sedation for the patient, and longer recovery
`
`periods than endovascular procedures.
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`- 2 -
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`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
`CASE NO. C07-00567 MMC
`
`IPR2019-00123 Page 00003
`
`

`

`Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 4 of 7
`
`
`HISTORY OF THE TREATMENT OF ANEURYSMS
`
`A.
`One example of the tremendous benefit of self-expanding shape memory alloy medical
`
`17.
`
`devices is found in the history of the treatment of aneurysms. An aneurysm is a weakening in the
`
`wall of a blood vessel, such as the aorta, where the walls enlarge and thin to the point where a
`
`rupture of the blood vessel can occur. If the aorta ruptures, within just a couple of heartbeats, the
`
`rapid blood loss can cause the death of the patient.
`18.
`
`Aneurysms are becoming more prevalent – over the last 30 or 40 years, there has been
`
`about a 300 percent increase in the prevalence of aneurysms.
`19.
`
`The first successful aneurysm repair using surgical graft replacement was performed in
`
`San Francisco by Dr. Norman Freeman in 1951. Within a month, Charles Dubost in Europe also
`
`accomplished this feat.
`20.
`
`In 1953, Michael DeBakey performed the first prosthetic graft repair of an aortic
`
`aneurysm using his wife’s sewing machine to make graft to treat the aneurysm.
`21.
`
`Dr. Julio Palmaz in the 1980s began working on the concept of an intravascular stent or a
`
`strut type of a structure that would provide a scaffold to hold the artery open and prevent it from
`
`re-collapsing. Such stents are still used today to treat arterial narrowing or stenoses.
`22.
`
`The FDA approved the use of such endovascular stents in 1991 in the United States for
`
`use in peripheral arteries and in 1994 for use in coronary arteries.
`23.
`
`Dr. Juan Parodi used a stent to fix a graft fabric to the aortic neck; thus, combining the
`
`concepts together to perform the first successful endovascular repair in a human in 1991.
`24.
`
`Using the concept of endovascular repair with a stent graft, one could treat an aneurysm
`
`through small groin incisions by placing the device through the femoral artery. This had a
`
`dramatic impact on morbidity and mortality, and a great benefit to patients.
`25.
`
`Dr. Michael Dake also worked on developing homemade Z-stents to which he sewed a
`
`Dacron graft material. Dr. Dake first used his homemade Z-stents in 1992. Dr. Dake and I began
`
`using these devices to treat aortic aneurysms in 1993.
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`- 3 -
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`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
`CASE NO. C07-00567 MMC
`
`IPR2019-00123 Page 00004
`
`

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`Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 5 of 7
`
`
`26.
`
`There was an explosion of interest in the intravascular field which led to the commercial
`
`development of a number of different devices which quickly were adopted for the treatment of
`
`vascular disease.
`B.
`Generally, self-expanding medical devices made from shape memory alloys are delivered
`
`USE OF SELF-EXPANDING MEDICAL DEVICES
`
`27.
`
`into patients using their own specially designed delivery catheter systems.
`28.
`
`Because of the self-expansion aspect of the devices, the device must be constrained into a
`
`deformed shape having a smaller diameter to fit within a delivery system; otherwise a physician
`
`could not deliver the device through the patient’s vasculature.
`29.
`
`The general steps of implanting an endovascular device are as follows: first a small
`
`incision is made, so as to gain access to a vein or artery which leads to the site of the defect. A
`
`constrained device, which is attached to a delivery catheter system, is advanced through the
`
`vasculature of the patient to the site of the defect to be treated. When the device is located at the
`
`correct position, the physician removes the restraint so that the constrained device may self-
`
`expand into its fully opened shape.
`30.
`
`Physicians typically are specifically trained to use a particular device before implanting
`
`that type of device into patients. In some cases, absent appropriate training, a medical device
`
`company will not allow a physician to order their devices without having first completed such
`
`training. Directions for implantation procedures are provided with each device, in the form of
`
`Instructions for Use. The IFUs contain step-by-step instructions on how to implant the device
`
`into patients.
`C.
`As examples of successful medical devices made from shape memory alloys, there are
`
`DEVELOPMENT OF INTRAVASCULAR STENTS
`
`31.
`
`currently several self-expanding devices sold by several different companies that have been
`
`approved by the FDA for use in the United States. For example, Medtronic currently sells the
`
`AneuRx and Talent endograft products in the United States. W.L. Gore & Associates sells the
`
`EXCLUDER, TAG, VIABAHN, VIABIL and VIATORR products in the United States and
`elsewhere. AGA Medical sells the AMPLATZER® Septal Occluder, Multi-Fenestrated Septal
`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
`CASE NO. C07-00567 MMC
`
`- 4 -
`
`
`
`
`
`IPR2019-00123 Page 00005
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`

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`Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 6 of 7
`
`
`Occluder – “Cribriform,” PFO Occluder, Duct Occluder I and II, Membranous VSD Occluder,
`
`Muscular VSD Occluder, P.I. Muscular VSD Occluder, and Vascular Plug I, II, and III products
`
`in the United States and elsewhere.
`32.
`
`Over the course of my career, I have developed extensive personal experience in
`
`implanting a number of these self-expanding, shape memory alloy medical devices into patients.
`
`In my personal professional experience as a surgeon and an academic, as well as through my
`
`participation in professional organizations related to the treatment of cardiovascular disease, I
`
`have become very familiar with the industry’s widespread adoption of self-expanding medical
`
`devices made from shape memory alloys. Self-expanding devices made of shape memory alloys
`
`have been adopted as the best practices for treating patients with certain cardiovascular
`
`conditions, such as aneurysms.
`33.
`
`In order to be safe and effective for their intended purposes, it is my opinion that it is
`
`important that self-expanding medical devices fully deploy to their intended shape at body
`
`temperature, and also that the device maintains its fully deployed shape over the life of the
`
`product.
`34.
`
`I understand that early researchers such as Dr. Cragg attempted to develop medical
`
`devices made using shape memory alloys that required careful temperature control while being
`
`implanted.
`35.
`
`In the course of my career, I am not aware of any self-expanding medical device used to
`
`treat patients that has ever been sold that required the physician to actively control the
`
`temperature of the device or its delivery system during implantation. The need for such
`
`affirmative temperature control during implantation would have been very detrimental to the
`
`acceptance and adoption of such devices in medicine, and would have caused greater risks to
`
`patients in terms of safety and efficacy of the treatment than the devices not requiring temperature
`
`control.
`III.
`36.
`
`
`
`
`
`SECONDARY CONSIDERATIONS
`I understand that AGA’s AMPLATZER® Septal Occluder, Multi-Fenestrated Septal
`Occluder – “Cribiform,” PFO Occluder, Duct Occluder I and II, Membranous VSD Occluder,
`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
`CASE NO. C07-00567 MMC
`
`- 5 -
`
`IPR2019-00123 Page 00006
`
`

`

`Case 3:07-cv-00567-MMC Document 372 Filed 03/16/2009 Page 7 of 7
`
`1 Muscular VSD Occluder, P.I. Muscular VSD Occluder, and Vascular Plug I, II, and III and their
`
`corresponding delivery systems are being accused of infringing the Jervis patents-in-suit. I
`
`further understand that the device portion of these products are constructed from nitinol, and that
`
`these devices are self-expanding medical devices used for the treatment of patients.
`
`37.
`
`From my professional experience, it is my opinion that the shape memory alloy, self-
`
`expanding devices such as those sold by Medtronic and W.L. Gore & Associates have been
`
`adopted as state of the art endovascular treatments for treating patients, and all of these products
`
`have enjoyed commercial success.
`
`38.
`
`It is my opinion that self-expanding nitinol medical devices that deploy at body
`
`temperature without any need for temperature control have fulfilled a long-felt need in medicine
`
`to repair such problems as aneurysms. Prior to these types of devices, open surgery was the only
`
`option.
`
`39.
`
`For these reasons, I personally use nitinol self-expanding medical devices made from
`
`shape memory alloys almost exclusively, when I treat aneurysms.
`
`I hereby declare under penalty of perjury under the laws of the United States that the
`
`foregoing is true and correct.
`jt..
`Executed this ~ay of March, 2009, at Stanford, California.
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`- 6 -
`
`DECLARATION OF DR. CHRISTOPHER K.
`ZARINS, M.D.
`CASE NO. C07-00567 MMC
`
`IPR2019-00123 Page 00007
`
`

`

`Case 3:07-cv-00567-MMC Document 372-2 Filed 03/16/2009 Page 1 of 42
`
`Exhibit 1
`
`IPR2019-00123 Page 00008
`
`

`

`• Chxistopher K. Zarins -Faculty & Researcher Profiles - Stanford School of Medicine
`Page 1 of 14
`Case 3:07-cv-00567-MMC Document 372-2 Filed 03/16/2009 Page 2 of 42
`
`•
`
`,•,., ,I,,..,,, • •' , •: -• ,.,
`
`"'
`
`-. t ,• "!
`
`,
`
`•~
`
`• '"',•,-y",.:.' ,',_;.,
`
`••• •'•••• •1.,1':',..f,,"~,
`
`Christopher K. Zarins
`Email: zarins@stanford.edu
`Profile: .!:ltm;llmed stanford .edu/profiles/.Q.IJ.rultopher Zari.mil
`
`Alternate Contact:
`Name: Maria L. Martinez
`Title: Administrative Associate
`Emall: marialm@Stanford~
`Phone: 650-723-2169
`
`Appointments
`Appointment
`Professor
`
`Member
`
`Organization
`Surpe,y. Vascular Surgery
`
`Bio-X
`
`le! Biosketch available online
`
`Graduate & Fellowship Program Affiliations
`Surgery;
`
`. . . . . ·•. . . \',": =.
`
`. ~ .,_ .••. ,. : "" ..
`
`Honors & Awards
`Title
`
`Phi Beta Kappa
`
`OrganlzaUon
`
`Lehigh University
`
`Association for Academic Surgery
`Resident Research Award
`Latvian Academy of Sciences Pauls Stradina Prize In Republic of Latvia
`Medicine
`Three Star Order, Republic of Latvia
`
`Republic of Latvia
`
`Date(s)
`
`1964
`
`1972
`
`1998
`
`2003
`
`Adl'.llinistratlve Appointments
`Title
`Acting Chairman, Department of Surgery
`Chief of Vascular Surgery
`Vice Chalnnan, Department of Surgery
`Chief of Vascular Surgery
`
`Organlxation
`
`Start Year
`
`Start Year
`
`Stanford University
`Stanford University Meaica/ Center; Stanford, CA
`
`The University of Chicago
`
`Tile Universlt.y of Chicago Medical Center
`
`1995
`
`1993
`
`1985
`
`1978
`
`1997
`
`2005
`
`1989
`
`1993
`
`Professional Education
`Awarding Institution
`Degree
`Graduation Date
`
`Field of Study
`
`BA
`1984
`MD
`1968
`
`lntem
`1969
`
`residency
`1974
`
`feDow
`1972
`
`chief resident
`1974
`
`Lehigh University, Bethlehem. PA
`
`Biology
`
`Johns Hopkins Univ School of Med
`
`Medicine
`
`• University of Michigan
`
`Surgery
`
`University of Michigan
`
`General Surgery
`
`Johns Hopkins Hospital
`
`Surgical Research
`
`University of Michigan·
`
`resident
`
`http://med.stanford.edu/profiles/frdActionServlet?choiceld=printerprofile&fid=4250
`
`9/6/2007
`
`IPR2019-00123 Page 00009
`
`

`

`Case 3:07-cv-00567-MMC Document 372-2 Filed 03/16/2009 Page 3 of 42
`Christopher K. Zarins - Faculty & Researcher Profiles - Stanford School of Medicine
`Page 2 of 14
`
`Web Site Links
`Research/Lab website: bllp_;llwrov...§ta.n.fm:g,~_groyp/zarinslab(
`
`Research Interests
`
`Hemodynamic factors in atherosclerosis, pathogenesis of, aortic aneurysms, carotid plaque localization and complication,
`anastomotic intimal hyperplasia, vascular biology of artery wall, computational fluid dynamics as applied to blood flow and
`vascular disease.
`
`A full list of publication with pdf at: (copy/paste the following URL to browser)
`
`http:/1171.65.102.190/zarins_bib/zarins_bibliography.html
`
`Community and International Work
`• Latvian Medical Foundation, Latvia
`
`Publications
`1. Benharash P, Lee JT, Abilez OJ, Crabtree T, Bloch DA, Zarlns CK "Iliac fixation Inhibits migration of both
`suprarenal and lntrarenal aortic endografts." J Vase Surg. 2007; 45: 2: 250-7,
`2. Goergen CJ, Johnson BL, Greve JM, Taylor CA, Zarlns CK "Increased Anterior Abdominal Aortic Wall
`Motion: Possible Role In Aneurysm Pathogenesis and Design of Endovascular Devices." J Endovasc Ther.
`2007; 14: 4: 574-584.
`3. Abilez o, Benharash P, Miyamoto E, Gale A, Xu C, Zarlns CK "P19 progenitor cells progress to organized
`contracting myocytes after chemical and electrical stimulation: impllcatlons for vascular tissue
`engineering/ J Endovasc 7her. 2006 May-Jun; 13: 3: 377-88.
`4. Zarlns CK, "Reply." J Vase Surg. 2006; 43: 1: 200.
`5. Zarins CK, Crabtree T, Arko FR, Heikkinen MA, Bloch DA, Ouriel K, White RA "EJVES: Response to Letter
`to the Editor-December 6, 2005 Endovascular Repair or Surveillance or Patient with Small AAA." Eur 1
`Vase Endovasc Surg. 2006;
`6. Guldoin R, Zhang z, Douvllle Y, Bonny JM, Renou JP, Basie MF, Zarlns CK, Legrand AP, Guzman R "MRI
`virtual biopsies: analysis of an explanted endovascular device and perspectives for the future." Artlf
`Cells Blood Substlt Immobil Blotechnol. 2006; 34: 2: 241-61.
`7. Heikkinen MA, Alsac JM, Arko FR, Metsanoja R, Zvalgzne A, Zarins CK "The Importance of mac fixation In
`prevention of stent graft: migration." J Vase Surg. 2006; 43: 6: 1130-7; discussion 1137.
`s. Guldoln R, Zhang z, Douvllle Y, Basie MF, Grlzon F, Marlnov GR, Zarlns CK, Legrand AP, Guzman R
`"Polymethylmethacrylate (PMMA) as an embedding medium preserving tissues and foreign materials
`encroaching In endovascular devices." Artlf Cells Blood Substlt Immobll Blotechnol. 2006; 34: 3: 349-
`66.
`9. Zarlns CK, Crabtree T, Bloch DA, Arko FR, Curiel K, White RA "Endovascular aneurysm repair at 5
`years: Does aneurysm diameter predict outcome?" J Vase Surg. 2006; 44: 5: 920-29; discussion 929-
`31.
`10. Lee ES, Bass A, Arko FR, Heikkinen M, Harris EJ, Zarins CK, van der Starre P, Olcott C "Intraoperatlve
`Colon Mucosal Oxygen saturation During Aortic Surgery." J Surg Res. 2006;
`11 •. Abilez o, Benharash P, Mehrotra M, Miyamoto E, Gale A, Picquet J, Xu C, Zarlns C "A novel culture
`system shows that stem cells can be grown In 3D and under physiologic pulsatlle conditions for tissue
`engineering of vascular grafts." J Surg Res. 2006; 132: 2: 170-8.
`12. Heikkinen MA, Dake MD, Alsac JM, Zarlns CK "Multiple HIV-Related Aneurysms: Open and Endovascular
`Treatment." J Endovase Ther. 2005 May-Jun; 12: 3: 405-10.
`13. Hill BB, Faruqi RM, Arko FR, Zarins CK, Fogarty TJ ""Over-the-Wire" Inversion Saphenectomy: A Simple,
`Minimally Invasive Vein Harvesting Technique for Arterial Bypass." J Endovasc Ther. 2005 May-Jun; 12:
`3: 394-400,
`14, Draney MT, Zarins CK, Taylor CA "Three-dimensional analysis of renal artery bending motion during
`respiration." J Endovasc 7her. 2005 May-Jun; 12: 3: 380-6.
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`15. Arko FR, Heikkinen M, Lee ES, Bass A, Alsac JM, Zarlns CK "Iliac fixation rength and resistance to In-vivo
`stent~graft dlsplacement.p J Vase Surg. 2005; 41: 4: 664-71,
`16. Singh TM, Hung R, Lebowitz E, Wallbom A, Shaver o, Soria J, Zarlns CK "Endovascular repclir of
`traumatic aortlc pseudoaneurysm with associated cellacomesenterlc trunk." J Endovasc Ther. 2005; 12:
`1: 138-41.
`17. Roos JE, Hellinger JC, Hallet R, Fleischmann D, Zarins CK, Rubin GD "Detection of endograft fractures
`with multldetector row computed tomography.• J vase Surg. 2005; 42: 5: 1002-6. ·
`18. HIii BB, Ghan AK, Faruqf RM, Arko FR, Zarlns CK, Fogarty Tl "Keyhole technique for autologous
`brachlobasillc transposition arterlovenous fistula." J vase Surg. 2005; 42: 5: 945-50.
`19. Karwowski J, Zartns CK "Endograftlng of the abdominal aorta and lilac arteries for occlusive disease." J
`cardlovasc Surg (Torino). 2005; 46: 4: 349-57.
`20. Zarins CK, Crabtree T, Arko FR, Heikkinen MA, Bloch DA, Ouriel K, White RA "Endovascular
`repair or surveillance of patients with small AAA." Eur J Vase: Endovasc Surg. 2005; 29: s:
`496-503; discussion 504.
`21. Nanjo H, Sho E, Komatsu M, Sho M, Zarlns CK, Masuda H "Intermittent short-duration exposure to low
`wall shear stress Induces Intimal thickening In arteries exposed to chronic high shear stress." Exp Mo/
`Pathol. 2005;
`22. Afsac JM, Zarins CK, Heikkinen MA, Kaiwowskl J, Arko FR, Desgranges P, Roudot-Thoraval F, Becquemin
`JP "The impact of aortic endografts on renal function." J Vase Surg. 2005; 41: 6: 926w30.
`23. Zarins CK, Heikkinen MA, Lee ES, Alsac )M, Arko FR "Short- and longwterm outcome following
`endovascufar aneurysm repair. How does It compare to open surgery?" J cardiovasc Surg (Torino).
`2004; 45: 4: 321-33.
`24. Heikkinen MA, Arko FR, Zarins CK "What Is the significance of endoleaks and endotenslon." Surg Clln
`North Am. 2004; 84: 5: 1337-52.
`25. Zarfns CK, "Stent-graft migration: how do we know when we have It and what Is Its significance?" J
`Endovasc Ther. 2004; 11: 4: 364-5.
`26. Draney MT, Arko FR, Alley MT, Marki M, Herfkens RJ, Pelc NJ, Zarlns CK, Taylor CA "Quantification of
`vessel wall motion and cyclic strain using cine phase contrast MRI: In vivo validation In the porcine
`aorta." Magn Reson Med. 2004; 52: 2: 286-95.
`27. Zarins CK, Arko FR, Crabtree T, Bloch DA, Ourlel K, Allen RC, White RA "Explant analysis of AneuRx
`stent grafts: relationship between structural findings and cflnlcal outcome.• J Vase Surg. 2004; 40: 1: 1-
`11.
`28. Arko FR, FIiis KA, Heikkinen MA, Johnson BL, Zarlns CK "Duplex scanning after endovascular aneurysm
`repair: an alternative to computed tomography,• Semln Vase Surg. 2004; 17: 2: 161-5.
`I
`29. Arko FR, Lee E, Zarlns CK, Fogarty Tl "Controlled localized thrombolysfs with the •turbo" trelfls to treat
`acute arterial occlusions tollowlng major surgery." J Endovasc Ther. 2004; 11: 3: 339-43.
`30, Sho E, Nanjo H, Sho M, Kobayashi M, Komatsu M, Kawamura K, Xu c, Zarlns CK, Masuda H "Arterial
`enlargement, tortuoslty, and Intimal thickening In response to sequential exposure to high and low wall
`shear stress." J Vase Surg. 2004; 39: 3: 601-12,
`31. Arko FR, FIils KA, Seidel SA, Gonzalez J, Lengle SJ, Webb R, Rhee J, Zarfns CK "How many patients with
`infrarenaf aneurysms are candidates for endovascufar repair? The Northern California experience." J
`Endovasc 1her. 2004; 11: 1: 33-40.
`32. Sarac TP, HIiieman D, Arko FR, Zarlns CK, Ourlel K "Clinical and economic evaluation or the trellis
`thrombectomy device for arterial occlusions: preliminary analysis." J Vase Surg. 2004; 39: 3: 556-9.
`33. Chang OW, Schubart PJ, Veith Fl, Zarins CK "A new approach to carotid angioplasty and stentlng with
`transcervical occlusion and protective shunting: Why ft may be a better carotid artery Intervention." J
`Vase Surg. 2004; 39: 5: 994-1002.
`·
`34. Zarlns CK, Bloch DA "Mlsperceptfons regarding the long-term safety of the AneuRx stent graft.• J Vase
`Surg. 2004; 40: 3: 594·5.
`35. Fogarty Tl, Arko FR, Zarlns CK "Endograft technology: highlights of the past 10 years." J Endovasc
`Ther. 2004; 11 Suppl 2: 11192-9.
`36. Arko FR, Lee WA, Hill BB, Fogarty TI, zarlns CK "Hypogastrlc artery bypass to preserve pelvic
`clrculatlon: Improved outcome after endovascular abdominal aortic aneurysm repair." J Vase Surg.
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`2004; 39: 2: 404-8.
`37. Zarlns CK, Bloch DA, Crabtree T, Matsumoto AH, White RA, Fogarty Tl "Aneurysm enlargement
`followlng.endovascular aneurysm repair: AneuRx clinical trial," J Vase Surg. 2004; 39: 1: 109-17.
`38. Martinez BO, Zarlns CK, Daunt DA, Coleman LA, Saenz Y, Fogarty TJ, Hermann GD, Nezhat CR, Olsen·
`EK nA porcine model for endolaparoscoplc abdominal aortic repair and endoscopic training." JSLS. 2003
`Apr-Jun; 7: 2: 129-36.
`. 39. Zarlns CK, Bloch DA, Crabtree T, Matsumoto AH, White RA, Fogarty Tl "Stent gra~ migration after
`endovascular aneurysm repair: importance of proximal fixation.• J Vase Surg. 2003; 38: 6: 1264-72;
`discussion 1272.
`40. Arko FR, Cipriano P, Lee E, FIiis KA, Zarlns CK, Fogarty TJ "Treatment of axlllosubclavian vein
`thrombosis: a novel technique for rapid removal of clot using low-dose thrombolysls." J Endovasc Ther.
`2003; 10: 4: 733-8.
`41. Sho E, Komatsu M, Sho M, Nanjo H, Singh TM, Xu C, Masuda H, zarlns CK "High flow drives vascular
`endothelial celf proliferation during flow-Induced arterial remodeling associated with the expression of
`vascular endothelial growth factor." Exp Mo/ Pathal. 2003; 75: 1: 1-11.
`42. Zarlns CK, "A tribute to David B. Skinner, M.D." Ann Surg. 2003; 238: 1: 157-9.
`43. Arko .FR, Fills KA, Hill BB, Fogarty TJ, Zarlns CK "Morphologic changes and outcome following
`endovascular abdominal aortic aneurysm repair as a function of aneurysm size." Arch Surg. 2003; 138:
`6: 651-5; discussion 655-6.
`44. Arko FR, Hill BB, Reeves TR, Olcott C, Harris El, Fogarty TJ, Zarlns CK "Early and late functional
`outcome assessments following endovascular and open aneurysm repair." J Endovasc Ther. 2003; 10:
`1: 2-9.
`45. Masuda H, Kawamura K, Nanjo H, Sho E, Komatsu M, Sugiyama T, Suglta A, Asari Y, Kobayashi M,
`Eblna T, Hoshl N, Singh TM, Xu C, Zarlns CK "Ultrastructure of endothelial cells under flow alteration."
`MFcrosc Res Tech. 2003; 60: 1: 2-12.
`46. Arko FR, Fills KA, Siedel SA, Johnson BL, Drake AR, Fogarty Tl, Zarins CK "Intrasac flow velocities
`predict sealing of type II endoleaks after endovascular abdominal aortic aneurysm repair." J Vase Surg.
`2003; 37: 1: 8-15.
`47. Zarins CK, "The US AneuRx Clinical Trial: 6-year clinical update 2002.• J Vase Surg. 2003; 37: 4: 904-8.
`48. Ftlls KA, Arko FR, Rubin GD, Zarlns CK "Three-dlmenslonal CT evaluation for endovascular abdominal
`aortic aneurysm repair. Quantitative assessment of the lnfrarenal aortic neck." Acta Chlr Belg. 2003;
`103: 1: 81-6.
`49. Arko FR, HIii BB, Olcott C, Harris El, Fogarty TJ, Zarlns CK "Endovascular repair reduces early and late
`morbidity compared to open surgery for abdominal aortic aneurysm." J Endavasc Ther. 2002; 9: 6:
`711-8.
`50. Fills KA, Arko FR, Rubin GD, Raman B, Fogarty Tl, Zarins CK "Aortolllac angulatlon and the need for
`secondary procedures to secure stent graft fixation: which angle Is Important?" Int Anglo!. 2002; 21: 4:
`349-54.
`
`51. Draney MT, Herfk:ens Rl, Hughes Tl, Pelc NJ, Wedding KL, Zarlns CK, Taylor CA "Quantification of vessel
`wall cyclic strain using cine phase contrast magnetic resonance Imaging." Ann Blomed Eng. 2002; 30:
`8: 1033-45.
`52. Sho E, Sho M, Singh TM, Nanjo H, Komatsu M, Xu C, Masuda H, Zarlns CK "Arterial enlargement In
`response to high flow requires early expression of matrix metalloprotelnases to degrade extracellular
`matrix." Exp Mo/ Pathol. 2002; 73: 2: 142-53.
`53. Ku JP, Draney MT, Arko FR, Lee WA, Chan FP, Pelc NJ, Zarlns CK, Taylor CA "In vivo validation of
`numerlca.1 prediction of blood flow In arterial bypass grafts." Ann Blamed Eng. 2002; 30: 6: 743-52.
`54. Xu C, Zarlns CK, Glagov S "Blphaslc response of tropoelastln at the poststenotic dilation segment of the
`rabbit aorta." J Vase Surg. 2002; 36: 3: 605-12.
`55. Wolf YG, Tlllich M, Lee WA, Fogarty Tl, Zarlns CK, Rubin GD "Changes in aneurysm volume after
`endovascular repair of abdominal aortic aneurysm.• J Vase Surg. 2002; 36: 2: 305-9.
`56. Arko FR, Lee WA, HIii BB, Olcott C, Dalman RL, Harris El, Cipriano P, Fogarty TJ, Zarlns CK "Aneurysm(cid:173)
`related death: primary endpoint analysis for comparison of open and endovascular repair." J Vase Surg.
`2002; 36: 2: 297-304.
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`57, Zarlns CK, Shaver OM, Arko FR, Schubart Pl, Lengle SJ, Dixon SM "Introduction of endovascular
`aneurysm repair Into community practice: Initial results with a new Food and Drug Administration(cid:173)
`approved device." J Vase Surg. 2002; 36: 2: 226-32; discussion 232-3.
`58. Xu c, Lee S, Shu C, Masuda H, Zarlns CK "Expression ofTGF•betal and beta3 but not apoptosls factors
`relates to flow-Induced aortic enlargement: BMC cardiovasc Dlsorcl. 2002; 2: 1: 11.
`59. Fills KA, Arko FR, Johnson BL, Plplnos II, Harris El, Olcott c, Zarlns CK "Duplex ultrasound criteria for
`defining the severity of carotid stenosls. • Ann Vase Surg. 2002; 16: 4: 413·21.
`60. Lee WA, Wolf YG, HIii BB, Cipriano P, Fogarty TI, Zarlns CK ''The first 150 endovascular AM repairs at a
`single Institution: how steep Is the learning curve?" J Endovasc Ther. 2002; 9: 3: 269-76.
`·
`61. HIii BB, Wolf YG, Lee WA, Arko FR, Olcott C, Schubart Pl, Dalman RL, Harris El, Fogarty Tl, Zarlns CK
`"_Open versus endovascular AAA repair in patients who are morphologlcal candidates for endovascular
`treatment." J Endovasc Ther. 2002; 9: 3: 255-61.
`62. Loth F, Jones SA, Zarins CK, Giddens DP, Nassar RF, Glagov S, Bassiouny HS "Relative contribution of
`wall shear stress and Injury In experimental Intimal thickening at PTFE end-to-side arterial
`anastomoses." J Biomech Eng. 2002; 124: 1: 44·51.
`· 63. Sho M, Sho E, Singh TM, Komatsu M, Suglta A, Xu C, Nanjo H, Zarlns CK, Masuda H "Subnormal shear
`stress-Induced Intimal thickening requires medlal smooth muscle cell proliferation and migration." Exp
`Mo/ Pathol. 2002; 72: 2: 150-60.
`64. Veith FJ, Baum RA, Ohkl T, Amor M, Adlseshlah M, Blankensteljn JD, Buth J, Chuter