Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA949204
`01/22/2019
`
`ESTTA Tracking number:
`
`Filing date:
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`Proceeding
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`Address
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`Submission
`
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`Date
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`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`92066392
`
`Plaintiff
`Covidien LP
`
`KATIE BUKRINSKY
`MCDERMOTT WILL & EMERY LLP
`500 NORTH CAPITOL ST NW
`WASHINGTON, DC 20001-1531
`UNITED STATES
`jdabney@mwe.com, mhallerman@mwe.com, ksandacz@mwe.com,
`dciplit@mwe.com
`202-756-8000 X 8194
`
`Other Motions/Papers
`
`Katie Bukrinsky
`
`kbukrinsky@mwe.com, jdabney@mwe.com, mhallerman@mwe.com, ksan-
`dacz@mwe.com, dciplit@mwe.com
`
`/s/ Katie Bukrinsky
`
`01/22/2019
`
`Ex. 47 - Cov-SOFT01005.pdf(797975 bytes )
`Ex. 48 - Cov-SOFT01033.pdf(842050 bytes )
`Ex. 49 - Cov-SOFT01034.pdf(950419 bytes )
`Ex. 50 - Cov-SOFT01049.pdf(689549 bytes )
`Ex. 51 - Cov-SOFT01050.pdf(1029367 bytes )
`Ex. 52 - Cov-SOFT01102.pdf(2555993 bytes )
`Ex. 53 - Cov-SOFT00586.pdf(3066531 bytes )
`Ex. 54 - Cov-SOFT00997-Cov-SOFT01004.pdf(637519 bytes )
`Ex. 55 - Cov-SOFT00514.pdf(1377503 bytes )
`Ex. 56 - Cov-SOFT01021 - ecri.pdf(4196206 bytes )
`Ex. 57 - dictionary - COAG.pdf(132106 bytes )
`Ex. 58 - CONFIDENTIAL.pdf(80714 bytes )
`
`

`

`BUKRINSKY
`
`BUKRINSKY
`EXHIBIT 47
`
`EXHIBIT 47
`
`

`

`154
`
`Poster Abstracts
`
`Methods: Data of patients diagnosed as Hemosuccus
`Pancrea ticus between March 2005 and March 2014 was
`retrospectively reviewed from a prospectively main(cid:173)
`tained database.
`Results: Twenty patients were diagnosed as Hemosuc(cid:173)
`cus Pancrea ticus. Seventeen patients were males and
`three were females (17 : 3). The presentation was with
`overt GI bleed in 17 patients (8 5%) , anemia in two
`(10%) and epigastric pain in one patient (5%). Twelve,
`six and two patients had associated chronic pancreati(cid:173)
`tis, tropical pancreatitis and acute pancreatitis respec(cid:173)
`tively. Bleeding through the ampulla could be identified
`at UGI scopy in nine patients (45%) . CT Angiography
`was performed in ll patients (55%).The arterial feeder
`was splenic artery in
`I 0(50 %) ,GDA in 8(40%) and
`pancreatico-duodenal vessels in 1(5%),hepatic a rtery in
`one (5%). Coil embolisation of feeding vessels was
`attempted in eleven (55%) and was succesfull in 11
`(77.8%). 9 (45 %) required surgery. The rebleeding rate
`was 18 % following embolisation which was trea ted by
`re-embolisation in one and surgery in one. The mortal(cid:173)
`ity was 10 %.
`stable patient
`Conclusion: In a hemodynamically
`Angio-embolisation offers better immedia te control of
`bleeding and is the preferred and safe initial treatment.
`Surgical intervention is indicated in a patient with hem(cid:173)
`orrhagic shock, impending rupture failed embolisation
`or if there is associated conditions which warrant defin(cid:173)
`itive surgery.
`
`Malignant HPB Diseases
`APHPB-0441
`
`SHORT-TERM OUTCOME OF
`LAPAROSCOPIC RADIOFREQUENCY
`ABLATION FOR HEPATOCELLUAR
`CARCINOMA IN LIVER CIRRHOSIS:
`THE SAFETY AND EFFICACY
`
`B. G. Na, G. S. Choi, J. M. Kim , C. H. D. Kwon , J.
`W . Joh, J.B. Park and S. J. Kim
`Surgery , Samsung Medical Center , Seoul, Korea
`
`Objectives: Radiofrequency ablation (RFA) has been a
`legitimate treatment for primary and metastatic hepato(cid:173)
`cellu lar carcinoma (HCC) with liver cirrhosis. The lapa(cid:173)
`roscopic RFA has replaced percutaneous RFA
`in
`HCCs that were considered to be infeasible because of
`poor sonic window, adjacent organ and major vessels.
`The aims of this study is to assess the clinical data and
`short-term outcome to evaluate efficacy and safety of
`laparoscopic RFA for HCCs with cirrhosis.
`Methods: Between September 2009 to August 2014, 45
`consecutive HCC patients with cirrhosis were treated
`by laparoscopic RFA . Most patients had hepatitis B
`(60%) and Child-Pugh class B status (90%). Median
`age was 60 years (range, 49- 84). The short-term out(cid:173)
`come was evaluated by radiologic inrnges in 3-, 6-, and
`9 months.
`Results: Laparoscopic RF A was done in all patients
`and 49 HCC nodules was completely ablated. There
`was no procedure related morbidity and mortality. The
`HCC nodules consisted of primary (n = 22) , recurred
`(n = 19) and metastatic lesions (n = 8). Median nodule
`diameter was 17 mm (range, 8-40). The 19 (45%) nod-
`
`© 2015 The Authors
`HPB © 20 15 Americas Hepato-Pancreato-Bili ary Association
`
`ules were located in segment 8. Median time of RFA
`was 14 min (range, 7- 28), while total operative time
`was 130 min (range, 63- 303). The combined procedure
`were adhesiolysis (n = 17), cholecystectomy (n = 2),
`colorectal surgery (n = I). The ho spital stay was 5 days
`(range, 3- 22) . The 3- , 6-, and 9-months disease-free sur(cid:173)
`vival rate was 97.2% , 83.2% , and 78.6% respectively.
`Conclusion: Laparoscopic RF A is a safe and effective
`therapeutic option for HCCs infeasible to percutaneous
`RFA in patients with cirrhosis. The laparoscopic RFA
`combines the advantage of clinical outcomes compara(cid:173)
`ble to those percutaneous RFA.
`
`APHPB-0442
`CURRENT STATUS OF LAPAROSCOPIC
`HEPATECTOMY, AND OUR
`TECHNIQUE FOR SAFETY OPERATION
`
`K. Shibuya, K. Matsui, I. Yoshioka, S. Sekine, I.
`Hashimoto, S. Hojo, R. Hori , T. Okumura, T. Nagata
`and K. Tsukada
`Department of Surgery & Science , University of
`Toyama, Toy ama-shi, Japan
`
`Objectives: In about 10 years laparoscopic hepatec(cid:173)
`tomy is spreading in our country. Only partial resection
`and lateral segmentectomy has been applied to national
`insurance. But currently, many reports of laparoscopic
`anatomical resection
`is
`increasing, because technica l
`improvement of laparoscopic hepatectomy has been
`achieved via the development of surgical devices. We
`also experienced cases of anatomical resection in recent
`years. So now , we report our situation of la paroscopic
`hepatectomy, and our technique for safety operation.
`Methods: Laparoscopic hepatectomy was introduced in
`our department from 2010. Initially, we used hybrid
`approach at mobilization for right or left lobe. From
`2012, pure laparoscopic approach has become possible
`in a ll caeses with technical improvement. From 2013 ,
`we
`introduced pre-coagulation
`technique by
`the
`monopolar forceps using soft-coagulation with saline
`dripping for all parenchymal dissection line .
`Results: 47 patients who have performed la paroscopic
`hepatectomy were identified between 2010 and 2014.
`The mean age was 65.9 years (range 29- 87), 33 were
`men. There are 32 cases of HCC, nine cases of liver
`metastas is, two cases of cholangiocellular carcinoma,
`and four of the benign tumors. It was applicable for
`partial resection in 37, subsegmentectomy in 3, segmen(cid:173)
`tectomy in 4, and lobectomy in 3. Tumor localization,
`SI /S2/S3 /S4/S5 /S6/S7 / S8: 2/ 6/6/ I 0/5/ 9/ 6/7. The mean
`tumor size was 2.4 cm diameter (range 1-4.6). The
`mean operation time was 267.9 min. There was no
`severe complication. After introduction of pre-coagula(cid:173)
`tion by soft-coagulation, intraoperative blood loss sig(cid:173)
`nificantly decreased (p = 0.0465).
`Conclusion: Laparoscopic hepatectomy with pre-coagu(cid:173)
`lation by soft-coagulation is safe and useful.
`
`HPB 2015 , 17 (Suppl. S2), 25- 266
`Cov-SOFT01005
`
`

`

`BUKRINSKY
`
`BUKRINSKY
`EXHIBIT 48
`
`EXHIBIT 48
`
`

`

`Abstracts
`
`.a d~ "'-' JUl 111:1.n ,. , il·1: •1 .;
`
`-:'.;:11:lric c, ·ciro ·n
`::i,,__,J,.11.1ll1:.•1
`-:MKdl>::leml:;::l.r>n· :1
`
`- :'.;u1ric c, ·eiron
`• -'L>:l@n:lll C!r
`
`lur1u11hlli.l.lu1 l ... ,lll
`
`- P.-'lrt lMlT hli ... 1h( ,111-'I" ' 1 ,1.:vl. •~ ir .-.- 1
`H,-1 ,u~ , 1- "
`
`Recurrent bleed ing within 30 days
`· Duration fro m in it ia l hemostasis (day)
`· Endoscop ic he mostasis
`· Angiographic embolization
`
`Overa ll morta lity
`· Bleed ing rela ted
`· Non-bleed ing relat ed
`Hospita l stay (day)
`
`APC
`(n = 48)
`
`4 (8.3%)
`
`4.7
`
`5.8
`
`4
`0
`2 (4.2%)
`1
`
`Forceps
`(n = 49)
`
`6 (12 .2%)
`
`4.7
`
`4.0
`
`5
`
`2 (4.1 %)
`0
`2
`
`P-value
`
`0.740
`0.986
`
`1.000
`
`8 .9
`
`9.7
`
`7.9
`
`3.9
`
`0.481
`
`l..Ct:I
`
`l\;10
`
`II ;tl:':.'lU ,1
`,\ ft" ::h, :.d, ,
`
`31l'~ Ji ~
`;;rc:.h \" O:Hi,
`
`Tu r II.I i1rillu1u , l 'l,ll 1
`Tm 111i1fil111111 1 : il1w
`
`- B HC q rn:p-r,IL-: :I r.u irit :ti litr:I~\-
`
`Va lues are mean
`
`SD
`
`Sa 16 11
`Treatment of Chronic Radiation Proctop a thy With Radiofreq uency
`Ablation
`Tarun Rustagi''' 1
`, F. Scott Corbett\ Hiroshi Mashimu ' · '
`1 Section of Digestive Diseases, Yale University School c!f Medicine, New
`Haven, CF; 2Sarasota Memorial Hospital, Sarasota, FL; 3VA Boston
`H ea lthcare System, Boston, MA; 4Harvard Medical School, Boston, MA
`Background : Chronic radiat io n procwpath y (C RP) is a co mmo n problem in patients
`receiving pelvic radiation. Cu 1Tent ablative th erap ies have the potential for d eep
`tiss ue injwy leading lO ulcerations, pe1foration, and fi st ulas. Racli.ofrequen cy ablation
`(RFA) therapy avoids deep tiss ue inju,y and is a pro mising treatmem for CRP. 111e
`aim of this study is lO assess the long-term safety and efficacy of RFA fo r the u·eat(cid:173)
`ment of CRP. Method s: nus is a multicenter, retrospective analys is of a prospective ly
`collected database of all CRP pa ti ents treated with RFA at VA Bosw n Healthcare
`System in Massachusetts, and Sarasota Memo rial Hospital and Suncoast Endosco py
`of Sarasota in Flo rida. RFA treatm e nt was perform ed using HALO90TM or HAL(cid:173)
`O60TM device (Covidien) at energy setting of 12J/c m 2
`. The primaiy endpoint of the
`stud y was complete resolutio n o f th e rectal bleecli.ng. Secondary endpoints included
`vis ually sco red improvement of CRP o n endoscopic follow-up, improve ment in he(cid:173)
`moglo bin , and adve rse eve nts related lO the procedure. Endoscopic severity o f CRP
`was scored using an accepted rectal telan giectasia density (RTD) gracli.ng scale.
`Desaiptive analysis was done using mean } standard deviation, median , range as
`applicable. Pre-tre-dtment and post-treaun e n t RTD scores and hemoglobin levels
`were compared using Wilcoxon signed-rank test. Results : 39 co nsec uti ve male pa(cid:173)
`tients (m eai1 age 72.9 6.6 years) we re included in the study. 59% had prior medical
`therapy and 36% had failed prior e nd osco pic therap y (m os tly argon plas ma coagu(cid:173)
`lation). Mean number of RFA sess io n was 1. 49 (median 1, range 1-4) with mean
`interval of 18 weeks between sessio ns. On average patients received 13 6.5 app li(cid:173)
`catio ns o f RFA per sessio n. Rectal bleecli.ng stopped comple te ly in all patients during
`the me an follo w- up of28 months (rai1ge 7-53). There was a significai1t improvement
`in mean he moglobin level fro m 11.8 2 lO 13.5 1.6 g m % (p<0.0001) with an ab(cid:173)
`solute mean inc rease of 1.7gm % (95% Cl : 1. 2-2.2) afte r tre-,ume nt (Fig ure lA).
`Endoscopic seve,ity also improved significantly witl1 an in1provem e m in mean RTD
`score from 2.68 0.48 lO 0. 68 0.98 (p<0.0001) with an absolute mean decrease of2
`(95 % CI: 1.64-2.36) (Figure lB). Trea tment with RFA led lO dis com inuation o f blood
`mmsfusion and iron tl1erapy in 92% ai1cl 82% patients , respective ly. Mild, trai,sient
`ai1orectal pain was reported after 12% u·eaunent sessio ns. Rectal ulcers , fistu la, o r
`stricture formation was not see n in ai1 y patient. Concl usio ns: RFA tl1erapy led lO
`co mplete resol uti o n of rectal bleeding in all u·eated CRP pat ients, witl1 improvemem
`in clini cal and endosco pi c indices wi thout any major co mplicatio ns. Th is is the firs t
`study lO repon th e long- te rm efficacy and safety of RFA fo r tl1e trea tment o f CRP.
`Further controlled studies are needed lO establis h RFA as tl1e endoscopic tl1e rapy of
`choi ce for treatment o f CRP.
`
`A
`
`P-...0.0001
`
`16
`15
`-;,. 14
`b, 13
`
`11
`.s 10
`
`! 12
`s 9 w
`•
`
`E
`1:
`
`0
`7
`
`5
`
`B
`
`3.0
`
`2.5
`
`ｾ＠ 20
`ｾ＠
`ｾ＠
`
`1.5
`
`1.0
`
`05
`
`00
`
`Sa 16 10
`Efficacy o f Hemostasis by So ft Co agulation Using End oscopic
`Hemostatic Forceps in Comparison With Argon Plasma
`Coagulation for Acu te Peptic Ulcer Bleeding: Preliminary Results
`of a Prosp ective Randomized Trial
`Jung-Wook Kim '", Jae Young Jang
`Internal Medicine, Kyung Hee University Hospital, Seoul, Republic of
`Korea
`Background/Aims: Endoscopic high-freque ncy soh coagu latio n is available for the
`ma nagement of bleeding o r nonbleeding vis ible vessels during endoscopic submu(cid:173)
`cosal dissection . However, its efficacy on pe ptic ulcer bl eeding has not been el uci(cid:173)
`dated so far. The aim of this s tudy was to evaluate the efficacy of he m os tasis with
`soft coagulation using hemostati c force ps b y compacing it with argon plasma
`coagulation (APC) in a prospective , randomized trial. Me thods : DUiing the period o f
`Janua,y 2012 lO Decembe r 2013 , 97 patie nts wit h pe ptic ulce r bleedi ng were
`e nrolled in this study. All o f these patients were randomly assigned into two groups:
`e pine ph,ine injection plus argon plas ma coagulatio n (APC group) or e pine phtine
`injection plus soh coagulatio n us ing he m os ratic fo rceps (Force ps group) . The p ri(cid:173)
`marv o utcome measure was recurren ce o f bleeding within 7 days and 30 days after
`inlti~ heinos tasis. Secondary outcomes measures were initial hemos tas is rate ,
`duration from initial he mostasis to the reculTence o f bleeding, complication rate,
`and hospi tal mortali ty. Res ults: Patie nt de mographi cs and ulcer characteristi cs
`including les io n size and Fo rrest classificati o n were co mpa rable between the groups.
`A wtal of the 45 (93.8%) o f 48 patients in APC group and 46 (93.9%) o f 49 patients in
`Fo rceps group were successfull y treated with APC o r soft coagulation alone,
`res pecti ve ly. Initial endoscopic hemo stasis with single or combined modality was
`achi eved in all patients. Fo ur patients (8.3%) in APC g roup and six patients (12.2%)
`in Forceps group expe ti encecl recurrem bleeding within 30 days (p = 0. 740) . Re(cid:173)
`bleed ing rates within 7 clays we re 4.2% (2/48) and 10.2% (5/49) in the APC and
`Force ps g roups, respectively (p = 0.436). Mean duration from initial hemos tasis lO
`4.0; p = 0.986). 111e re was no s ig(cid:173)
`th e recuLTence was similar (4.7
`5.8 vs . 4.7
`nifican t difference in terms of th e volume of the epinephrine solution injection (6 .6
`vs . 5.9 m.L), mean numbe r of units o f blood tran sfusio n (3.3 vs. 3.6 units), co mpli(cid:173)
`cation rate (0% vs. 4. 1%) , mean hos pital stay (8.9 vs. 7.9 clays), and hospital mortality
`(4.2% vs. 4. 1%). Conclusions: This stud y showed that soh coagulation using e ndo(cid:173)
`sco pi c hemostatic forceps is as effective and safe as argon plas ma coagulation in the
`treatment o f patients with acu te peptic ulcer bleeding.
`
`Treatment results of enrolled patients
`
`Initial hemostasis with sin gle moda lity
`Initial hemostasis combined with other
`endoscopic mod alit y
`Epinephrine (m l)
`Emergency surgery
`Angiographic embolization
`Total complication
`- Perforation
`- Aspiration pneumonia
`Total procedure t ime (minute)
`Coagulation time (minute)
`Blood transfusion (un it)
`
`· Before endoscopy
`· After e ndoscopy
`Recurrent bleeding w ithin 7 da ys
`
`APC
`(n = 48 )
`
`Forceps
`(n = 49)
`
`45 (93.8%)
`3 (6.2%)
`
`46 (93 .9%)
`3 (6.1%)
`
`P-value
`
`1.000
`1.000
`
`6.6
`
`3.7
`
`5.9
`
`3.2
`
`0.3 17
`
`0
`0
`0 (0%)
`
`0
`0
`
`20.2
`11 .2
`2.0
`3.7
`2.8
`3.3
`1.2
`1.5
`2.2
`2.1
`2 (4.2%)
`
`0
`0
`2 (4.1%)
`
`0
`2
`7.9
`18.1
`1.7
`3.8
`2.3
`3.6
`1.8
`2.5
`1.8
`2.5
`5 (10.2%)
`
`0.495
`
`0.286
`0.816
`0.458
`0.990
`0.343
`0.436
`
`Pre. HI:,\
`
`Post RF.A
`
`Mean t-temogtob;ai Li!l>WI
`
`P1 1:1-RFA
`
`Po~l-RFA
`
`Figure 1 . Changes in hemoglobin level (A) and endoscopic score (B) af.
`ter RFA.
`
`www.giejo urna l.o rg
`
`Volume 79, No. 5S
`
`20 14 GASTROINTESTINAL ENDOSCOPY AB2 73
`
`Co v-SOFT01 033
`
`

`

`BUKRINSKY
`
`BUKRINSKY
`EXHIBIT 49
`
`EXHIBIT 49
`
`

`

`Surg Endosc
`
`DOI 10.1007/s00464-017-5829-x
`
`VIDEO
`
`.-a11,,,",:,..,,1o,...11 .. ~.;., ...
`
`.
`
`CrossMark
`
`Laparoscopic liver resection using a monopolar soft-coagulation
`device to provide maximum intraoperative bleeding control
`for the treatment of hepatocellular carcinoma
`
`2 CID · Masayasu Aikawa2
`Mitsuo Miyazawa1
`'
`• Isamu Koyama 2
`Kojun Okamoto2
`
`• Katsuya Okada2
`
`• Yukihiro Watanabe 2
`
`•
`
`Received: 14 March 2017 / Accepted: 17 August 2017
`Springer Science+Business Media, LLC 2017
`
`Abstract
`Background The popularity of laparoscopic liver resection
`(LLR) is spreading, worldwide, because the intraoperative
`blood loss is less than for open hepatectomy and it is
`associated with a shorter hospitalization period [1- 6].
`During LLR, intraoperative hemostasis is difficult to
`achieve, unlike during laparotomy where bleeding can be
`stopped instantly [7- 10]. Our LLR method for the treat(cid:173)
`ment of hepatocellular carcinoma (HCC) includes maximal
`control of intraoperative bleeding using a monopolar soft(cid:173)
`coagulation device. Although we use a monopolar soft(cid:173)
`coagulation device to control bleeding during LLR, while
`coagulating the thin blood vessels, we also developed a
`maneuver (the hepatocyte crush method: HeCM) to allow
`liver transection to progress while liver parenchymal cells
`are being crushed.
`Method Between January 2008 and March 2016, we per(cid:173)
`formed total LLR on 150 hepatocellular carcinoma patients
`(144 partial liver resections and six left lateral sectionec(cid:173)
`tomies) using the maneuver shown in the video.
`Results The patients had Child-Pugh Scores of grade A
`(n = 100), B (42), or C (n = 8) and the localizations of
`tumor were segment (S) l(n = 7) , S2 (19), S3 (23), S4
`
`Electronic supplementary material The online version of this
`article (doi: 10.1007/s00464-0l 7-5829-x) contains supplementary
`material, which is available to authorized users.
`
`(28), S5 (17), S6 (26), S8 (17), and S8 (29). The median
`blood loss was 30 (range 0-490) g during a median sur(cid:173)
`gical time of 207 (range 127-468) min. One patient
`required conversion to a laparotomy due to the presence of
`severe adhesions; none of the patients required conversion
`due to intraoperative hemorrhage. The peak aspartate
`aminotransferase (AST) level was 320 (range 57-1964) IU/
`L. Although some patients showed high AST levels, none
`showed signs of hepatic failure. The median postoperative
`hospital stay duration was 6 (range 3-21) days. Postoper(cid:173)
`ative complications occurred
`in seven cases (4.7%),
`including intraabdominal abscesses (n = 2), wound infec(cid:173)
`tions (2), intraabdominal hemorrhage (1), bile duct stricture
`(I), and umbilical hernia (1). The mortality was zero.
`Conclusion HeCM, combined with the use of a monopolar
`soft-coagulation device, is a good technique for reducing
`bleeding during liver resection in patients with HCC.
`
`Keywords Laparoscopic liver resection Liver transection
`method
`Intraoperative bleeding Monopolar soft(cid:173)
`coagulation device
`
`Compliance with ethical standards
`
`Disclosures Drs. Mitsuo Miyazawa, Masayasu Aikawa, Katsuya
`Okada, Yukihi.ro Watanabe, Kojun Okamoto and Isamu Koyama have
`no conflicts of interest or financ ial ties to disclose.
`
`ｾ＠Mitsuo Miyazawa
`mmiyazawa@med.teikyo-u.ac.jp
`
`References
`
`Department of Surgery, Teikyo University Mizonokuchi
`Hospital , 3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki-shi,
`Kanagawa, Japan
`
`Department of Surgery, Saitama Medical University
`International Medical Center, Saitama, Japan
`
`1. GellerDA Tsung A (20 15) Long term outcomes and safety of
`laparoscopic liver resection for HCC and metastatic liver cancer.
`J Hepatobiliary Pancreat Sci 22:728-730
`2. Wakabayashi G, Cherqui D, Geller DA, Buell JF, Kaneko H, Han
`HS , Asbun H, O' Rourke N, Tanabe M, Koffron AJ , Tsung A,
`
`Published online: 15 September 2017
`
`ｾ＠Springer
`
`Cov-SOFT01034
`
`

`

`Surg Endosc
`
`Soubrane 0, Machado MA, Gayet B , Troisi RI, Pessaux P, Van
`Darn RM, Scatton 0 , Abu Hila! M , Belli G , Kwon CH, Edwin B,
`Choi OH, Aldrighetti LA , Cai X, Cleary S, Chen KH, Schon MR,
`Sugioka A, Tang CN, Herman P, Pekolj J, Chen XP, Dagher I,
`Jarnagin W , Yamamoto M , Strong R, Jagannath P, Lo CM,
`Clavien PA, Kokudo N, Barkun J, Strasberg SM (20 15) Rec(cid:173)
`ommendations for laparoscopic liver resection: a report from the
`second international consensus conference held in Morioka. Ann
`Surg 261 :619-622
`3 . Han HS , Shehta A , Ahn S, Yoon YS, Cho JY , Choi Y (2015)
`Laparoscopic versus open liver resection for hepatoce llular car(cid:173)
`cinoma: case-matched study with propensity score matching.
`J Hepatol 63:643-645
`4 . Sposito C, Battiston C, Facciorusso A, Mazzola M, Muscara C,
`Scotti M , R omito R , Mariani L , Mazzaferro V (20 16) Propensity
`score analysis of outcomes following laparoscopic or open liver
`resection for hepatocellular carcinoma. Br J Surg 103:871-880
`5 . Takahara T , Wakabayashi G , Konno H, Gotoh M , Yamaue H,
`Yanaga K, Fujimoto J, Kaneko H, Unno M, Endo I, Seto Y,
`Miyata H, Miyazaki M , Yamamoto M (20 16) Comparison of
`
`laparoscopic major hepatectomy with propensity score matched
`open cases from the National Clinical Database in Japan.
`J Hepato biliary Pancreat Sci 23:721-734
`6. Ciria R , Cherqui D , Geller D, Briceno J, Wakabayashi G (2016)
`Comparative short term benefits of laparoscopic liver resection:
`9000 cases and climbing. Ann Surg 263:761-777
`7. Nguyen KT, Gamblin TC , Geller DA (2009) World review of
`laparoscopic
`liver
`resection-2804
`patients. Ann
`Surg
`250:83 1-841
`8. Belli G, Fantini C, Belli A, Lirnongelli P (20 11 ) Laparoscopic
`liver resection for hepatocellular carcinoma in cirrhosis: long(cid:173)
`term o utcomes. Dig Surg 28:134-140
`9. Pai M , Frampton AE, Mikhail S, Resende V, Kornasiewicz 0 ,
`Spalding DR, Jiao LR, Habib NA (20 12) Radiofrequency assisted
`li ver resection: analysis of 604 consecutive cases. Eur J Surg
`Oneal 38:274-280
`10. Piardi T , Sornrnacale D , Baumert T , Mutter D , Marescaux J,
`Pessaux P (2014) Laparoscopic resection for hepatocellular car(cid:173)
`cinoma: comparison between Middle Eastern and Western
`experience . Hepatobiliary Surg Nutr 3:60-72
`
`ｾ＠Springer
`
`Cov-SOFT01035
`
`

`

`BUKRINSKY
`
`BUKRINSKY
`EXHIBIT 50
`
`EXHIBIT 50
`
`

`

`UNMODERATED POSTER SESSIONS
`
`Conclusions: Obesity appears to repre(cid:173)
`sent an adverse prognosticator with re(cid:173)
`
`unilateral: 30%, P 0 .0001) . Pathological
`
`99.2°, 176 .1° and over 250°, respectively.
`
`findings (unilateral: clear cell 84%, papil(cid:173)
`
`The maxinrnm section temperature on
`
`spect to operative blood loss . However, it
`
`lary cell 14%, bilateral: clear cell 76%, pap(cid:173)
`
`SC7 , SC3, FC and Sp were 110.6°, 144 .1 °,
`
`does not appear to predict disease spe(cid:173)
`
`cific outcomes or intra-operative out(cid:173)
`
`illary 22%) , tumor grade, tumor size and
`pathological stage were not significantly
`
`158.6° and over 250°, respectively . The
`
`maximum temperature at 5mm and 7mm
`
`comes .
`
`different between the two groups. Longer
`
`deep were 58°, 31.5 ° on SC7 and 85 °, 62 °
`
`UP-01.206
`Prognosis and Characteristics of Renal
`
`Cell Carcinoma in Hemodyalisis
`Patients: Comparison Between
`Unilateral and Bilateral Occurrence
`Takagi T' , Kondo T' , Izuka J ' ,
`Kobayashi H' , Hashimoto Y' , Ito F' ,
`Nakazawa H 2
`, Tanabe K'
`'Dept. of Urology, Tokyo Women 's
`Medical University; 2 Medical Center East,
`Tokyo, J apan
`
`Introduction and Objective: Patients
`with end-stage renal disease (ESRD) re(cid:173)
`
`quiring hemodyalisis (HD) have a higher
`
`incidence of renal cell carcinoma (RCC)
`
`compared to the general population . Pa(cid:173)
`
`tients with bilateral sporadic RCC have a
`
`poor prognosis compared to those with
`
`unilateral RCC. Moreover, bilateral meta(cid:173)
`
`chronous occurrence of sporadic RCC
`
`was associated with an unfavorable prog(cid:173)
`
`nosis compared with bilateral synchro(cid:173)
`
`nous occurrence. In the previous report,
`
`duration of HD before surgery
`
`(P 0.0091), tmnor size (P 0.0112) and
`
`tumor grade (P 0 .0062) were unfavorable
`
`prognostic factors for death from RCC as
`
`shown by multivariate analysis.
`Conclusion: The type of occurrence of
`RCC , unilateral or bilateral, in HD patients
`
`on SC3 , respectively.
`Conclusions: The maxinnun temperature
`on SC7 or SC3 is lower than on FC or Sp.
`The thermal damage of kidney tissues is
`within 5mm or less on SC7. The tl1ermal
`
`damage of normal kidney tissues using the
`
`soft coagulation is limited, and this has
`
`did not appear to have influenced the can(cid:173)
`
`possibility to protect the residual renal
`
`cer specific survival. Patients with long
`
`function .
`
`duration of HD have to be followed
`
`strictly, because they tend to have bilat(cid:173)
`
`eral kidney cancer and poor cancer prog(cid:173)
`
`nosis .
`
`UP-01.207
`Thermal Damage of the Soft
`Coagulation in Pig's Kidney
`Ota T, Ochi A, Enatsu N, Ikeda A,
`Funada S, Rii J, Suzuki K, Shiga N,
`Komatsu H
`Dept. of Urology, Kameda Medical
`Center, Japan
`
`UP-01.208
`Survival Following Nephrectomy for
`Advanced Renal Cell Tumors With
`Renal Vein Involvement
`Yamamoto H' , Nemade H' ,
`Makanjuola J' , Lloyd G ' , Chowdhury S2
`Kooiman G'
`'Dept. of Urology; 2 Dept. of Oncology,
`King 's College Hospital, London, UK
`
`,
`
`Introduction and Objective: Advanced
`renal cell cancer (RCC) with renal vein
`
`involvement is associated with a poor
`
`Introduction and Objective: A suture of
`the kidney after a tumor resection in par(cid:173)
`
`prognosis .However, a multimodal ap(cid:173)
`
`proach consisting of cytoreductive ne(cid:173)
`
`cancer specific prognostic factors for HD
`
`tial nephrectomy sometimes induces
`
`phrectomy, systemic therapy and metasta(cid:173)
`
`patients with RCC have not been dis(cid:173)
`
`bleeding by the surgical needle, and an
`
`sectomy have been useful in prolonging
`
`cussed. In the present study, we analyzed
`
`injury of the arcuate or interlobbar artery
`
`tile overall and progression free survival.
`
`the prognosis and characteristics o f RCC
`
`causes of pseudo-aneurism or arterio-ve(cid:173)
`
`The objective is to determine the oncolog(cid:173)
`
`in HD patients after radical nephrectomy
`
`nous fistura . Furthermore, the ligation of
`
`ical outcome in our case series of patients
`
`normal kidney tissues makes ischemic
`
`and compared those with unilateral and
`
`who unde1went radical nephrectomy for
`
`bilateral occurrence.
`Materials and Methods: Two-hundred
`and forty six HD patients who underwent
`
`damage. It is well-known the soft coagula(cid:173)
`
`tion is useful and safety for stopping of
`
`hemorrhage and leakage in lung , liver and
`
`stage T3 and T4 renal carcinoma .
`Materials and Methods: Twenty-four
`consecutive patients underwent radical
`
`radical nephrectomy for RCC were the
`
`pancreas surgery. Major complications of
`
`nephrectomy (n 18) or cytoreductive
`
`subjects of the present study. Of these,
`
`partial nephrectomy are also hemorrhage
`
`nephrectomy (n 6), with or without sys(cid:173)
`
`unilateral RCC occurred in 201 patients,
`
`and leakage of urine. Then, we applied
`
`temic therapy.
`
`bilateral synchronous in 15 and bilateral
`
`the soft coagulation on partial nephrec(cid:173)
`
`metachronous in 30. Cancer specific sur(cid:173)
`
`tomy to avoid sutures, and reported tl1is
`
`Results: Mean age of the cohort was
`65
`lOyrs (M:F 5:1). Seventeen and 6 pa(cid:173)
`
`vival was accessed by Kaplan-Meier
`
`novel method was safety and useful. On
`
`tients underwent open and laparoscopic
`
`method .
`Results : Cancer specific survival was not
`significantly different between two
`
`the other hand a high temperature by an
`
`nephrectomy, respectively.Mean follow-up
`
`electrosurgical knife may damage normal
`
`time was 27 22months . The tumor was
`
`kidney tissues . Here , we investigated the
`
`inoperable in one patient.The proportion
`
`groups. (5-year: unilateral, 90%; bilateral,
`
`thermal effect of the soft coagulation us(cid:173)
`
`of disease stages were: T3a (46%), T3b
`
`90%; P 0 .9509). Seventeen patients of
`
`ing a pig 's kidney .
`
`(46%) , T3c and T4 (8%).In 6 patients, the
`
`201 (8.5%) with unilateral occurrence and
`
`4 patients of 45 (8 .9%) with bilateral oc(cid:173)
`
`Material and Methods: Using a pig 's
`kidney, the maximum temperature of sur(cid:173)
`
`disease was already metastatic .Five pa(cid:173)
`
`tients received adjuvant systemic tl1erapy
`
`currence died from kidney cancer in the
`
`face and section were measured by a ther(cid:173)
`
`(sunitinib or interferon) at 59 21days
`
`follow up periods . The presence of ACDK
`
`mography on condition of the soft coagu(cid:173)
`
`following surgery.Second line (n 4) , third
`
`(mtilateral , 73%; bilateral 91 %;
`
`lation effect 7 (SC7) , effect 3 (SC3) ,
`
`line (n 2), and fourth line (n 1) sys(cid:173)
`
`P 0.00319) and mean duration of hemo(cid:173)
`
`forced coagulation (FC) and spray coagula(cid:173)
`
`temic therapy was administered in some
`
`dialysis before surgery (unilateral:
`
`tion (Sp). The maximum temperature at
`
`patients.Four patients have died from dis(cid:173)
`
`157 9 lmonths, bilateral: 189 83.5 ,
`
`5mm and 7mm deep were measured by a
`
`ease progression.Kaplan-Meier analysis
`
`P 0.03 19) are significantly different be(cid:173)
`
`thermometer on condition of SC7 and
`
`revealed overall survival to be 86% at 24
`
`tween the two groups . Bilateral occur(cid:173)
`
`rence had more multifocal tmnors than
`
`with unilateral occurrence (bilateral: 74%,
`
`SC3 .
`Results: The maxin1tun surface tempera(cid:173)
`ture on SC7, SC3 , FC and Sp were 88.3 °,
`
`months .
`Conclusions: A multimodal approach
`consisting of radical surgery and systemic
`
`UROLOGY 78 (Supp lem ent 3A), September 2011
`
`Cov-SOFT01049 S257
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`

`BUKRINSKY
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`BUKRINSKY
`EXHIBIT 51
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`EXHIBIT 51
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`

`Kaplan-Meir curve o fm onalityaftu Initial endoscopic hemom.sis ( 10 yars foll ow-up)
`
`1.0 - - - - - - - - - - - - - - - - - - - - - - - ,
`
`0 .8
`
`,&
`ll!
`
`0 .8
`
`I
`
`Jl OA
`
`0 .2
`
`0 .0
`
`0
`
`2
`
`I =:: ｾｾｾｾｯｾｾｲｯｵｰ＠I
`
`IOg rank p-value<0.0001
`
`10
`
`165
`
`Num bct, 31 ris k
`P,ilionts wl th CKO grouop
`Pa1len1s wi1h N o u -CKO grouop
`
`78
`79S
`
`timelvearsl
`
`53
`650
`
`38
`487
`
`2 4
`
`3U
`
`Abbreviation. CKO chronec kdney disease
`
`Figure 2 . Kap lan-Me ir curve of mo rtali ty afte r ini tial e ndoscopic he rn os ta(cid:173)
`sis (10 years follow-up)
`
`Mo1372
`Investigation of Overt Upper Gastrointestinal Hemorrhage in
`Patients Administered DAPT and NOAC
`Toshihisa Take uchi '", Shinpe i Kawaguc hi , Yoshia ki Takahashi ,
`Satoshi Harada, Kaz uhiro Ota, Yuichi Ko jima, Kaz uhicl e Hig uchi
`2nd Dep of l n temal Med icine, Osaka Medical Collage, Tak a tsuki, Japan
`Backgrou nd: In assoc iat io n with th e increase in prevalence o f heart disease, the
`numbers of patie nts ad ministered d ual anti-plate let thera py (DAPT), and novel
`o ral an ticoagulants (NOACs) have ino-eased . However, tl1e ,is ks of overt upper
`gast rointestinal hemo tThage associated witl, DAPT and NOAC have not been suffi(cid:173)
`cientl y el ucidated. Objecti ves: To e luc idate tl,e races and risk fac to rs of overt up pe r
`gast rointestinal he mo rrh age in pa tie nts adm.iniscered DAPT and NOAC. Su bjects an d
`Methods: The s ubjects of tl,is study were patients who were ad minis te red DAPT o r
`NOAC for an extended period at o ur hos pi tal d uring cl,e 5-year pe1i od, and witl1
`who m esop hagogas crod uo denoscopy (EGO) was GUTied o ut because of some so rt
`of gastrointes tinal sym p to ms . Upper gastroin testinal he mo rrhage was classed as
`ove1t. , and e ndoscopic he mostasis was cani ecl o u t.
`The fo llowing in vestigatio ns were carried o ut:
`1. The rates of upper gas tro intestinal tract he mo rrhage wi th DAPT and NOAC
`ad nlinistratio n were decennined.
`2. The risks of upper gastro intestinal trace he mo ,,-hage witl, DAPT and NOAC
`adm.i ni.s tratio n were in ves tigated witl1 diffe re nt backgro und facto rs [H. py lori
`infection , co nco m.i tant NSAID ad m inisu a tio n, and conco mi tant proto n-pum p(cid:173)
`in h.ibi cor (PPI) ad m in is tration, e tc.]. Res ul ts: The numbers of patients in me
`DAPT and NOAC gro ups were 19 1 and 58, respectively.
`1. The num ber of hem o n-hagic pati ents in th e DAPT gro up was 25 (13%), and the
`num ber in che NOAC gro up was 5 (8.6%). 11,e re was no s ig nifica nt difference
`between th ese grou ps (p = 0.49).
`2. In che DAPT group, no significant d iffe rences in tl1 e background factors were
`fo un d between tl1e hemoIThagic an d no n-he motThagic gro ups. Amo ng patients
`co ncomitantly ad min iste red PP!s , 14 of 128 (10.1%) we re hemorrhagic, whereas
`amo ng tl1ose no t administered PPis 11 of 63 (17.1%) were he mo IThagic, an d
`th ere was again no significant di fference between tl1 ese groups (p = 0.2 1)