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TURIS – TRANSURETHRAL RESECTION IN SALINE

Review of clinical evidence for bipolar resection and plasma vaporization.

2

TURIS – CLINICAL BENEFITS

Safety1

· Reduced risk of TUR syndrome2

· Minimized stimulation of obturator nerve

· Extended operations times – way beyond monopolar

· Improved teaching options

Bloodless

· Reduced perioperative blood loss due to safe bipolar hemostasis

· Plasma vaporization with the PlasmaButton provides continuous hemostasis3

· Enucleation technique allows for a potentially blood-free procedure

Time-saving4

· Self-cleaning effect of loop wire through plasma activation

· Faster post-operative recovery

· Potentially decreased catheterization times

The benefits of TURis

The TURis bipolar resection system provides an outstanding versatility for the treatment of benign prostatic hyperplasia. At

the same time, it maintains all the benefits of bipolar resection in saline. As of today, more than one million successful clinical

cases have proved the safety of the TURis 2.0 system.*

Please see the references on page 9. *Data on file

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3

Please see the references on page 9.

TURIS – BIPOLAR PROCEDURES

Loop resection – instant ignition and continuous

activation

· Three effect options for obtaining the desired coagulation

zone

· Smooth cutting and good pathological samples

· High tissue ablation rate5

· All benefits of TURis

· Plasma vaporization enables continuous and safe

hemostasis

· Short learning curve and fast and easy set-up, just as

simple as standard resection

· Clear and unobstructed view throughout the operation as

neither tissue chips nor laser impulses impair vision

· The PlasmaButton leads to a smooth post-operative tissue

surface

· Potential for providing transurethral vaporization on a

day-case basis

· A fraction of the cost of PVP

Transurethral enucleation – a bipolar alternative

The TUEB electrode enables the fast enucleation of larger

prostates without having to invest in additional laser

technology. Transurethral Enucleation with Bipolar (TUEB)

allows for potentially blood-free procedures and a gentle

enucleation of the prostate.

Plasma vaporization – from laser to plasma vaporization

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4

Solid Liquid Gaseous Plasma

What is plasma?

Plasma is one of the four fundamental states of matter and is created by applying energy to a gas.

Molecules are ionized, thus turning the gas into a plasma. Due to its conductivity, the plasma allows the

energy to cross at lower energy levels. This effect leads to low operating temperatures and, therefore, less

thermal spread. Tissue is vaporized by a locally confined denaturation process, while surrounding tissue-

heating effects are minor. It appears yellow due to the sodium which is dissolved in the saline and –as of

today– more than one million successful clinical cases have proved the safety of the TURis 2.0 system.

Energy Energy Energy

Molecule Free charge carriers Free radicals

What is transurethral enucleation?

This revolutionary technique for the removal of the prostate utilizes

the natural anatomy by virtually peeling the prostate tissue out of

the capsule. The TUEB electrode’s wire loop is only used to locate

the layers and coagulate any bleeding – should this occur. Once

the right layers have been located, the black runner is used to

gently peel off the prostate lobes as a whole. The lobes are then

pushed into the bladder, where they are cut and eventually

removed. TUEB potentially produces the same functional results

as the current standard treatment while reducing operating times

for large prostates and – at the same time – keeping intra-

operative blood loss to a minimum.

TURIS – TECHNOLOGY AND TECHNIQUES

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5

TURis: The gold standard for TUR-P and TUR-B

The TURis bipolar resection system differs from monopolar resection in that the tissue effect takes place

between two electrodes that are part of the same device. The active and return electrode are within the

resectoscope, forming a bipolar electrosurgical system. Due to the conductive saline, only a very small fraction

of the current passes through the tissue, and no neutral electrode is required. In TURis, HF current is used to

create a plasma corona. After plasma ignition, cutting or vaporization can be performed.

The ESG-400 power curve with optimized energy output control – energy is immediately reduced after ignition

Power (W)

Time (t)

Plasma ignition

TURIS – TECHNICAL PRINCIPLE

ESG-400 – intelligent HF technology

The TURis bipolar system is powered by the ESG-400 HF generator which is equipped with various safety

features such as automated saline detection and leakage protection sensor to permanently ensure the highest

degree of safety for the user and the patient.

4.81

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6

BIPOLAR PLASMA VERSUS MONOPOLAR: REVIEW OF EVIDENCE

significantly. Irrigation and catheterization duration was

significantly longer with M-TURP (WMD: 8.75 h; 95% CI, 6.8–10.7

and WMD: 21.77 h; 95% CI, 19.22–24.32; p < 0.00001,

respectively). Inferences for hospitalization duration could not be

made. PlasmaKinetic TURP showed an improved safety profile.

Data on TUR in saline (TURis) are not yet mature to permit safe

conclusions.

Conclusions:

No clinically relevant differences in short-term efficacy

exist between the two techniques, but B-TURP is

preferable due to a more favorable safety profile (lower

TUR syndrome and clot retention rates) and shorter

irrigation and catheterization duration. Well-designed

multicentric/international RCTs with long-term follow-up

and cost analysis are still needed.

Keywords:

Benign prostatic hyperplasia, Bipolar, Electrosurgery, Meta-

analysis, PlasmaKinetic, Prostate, Randomized controlled trial,

Review, Saline, Transurethral resection of prostate

European Urology 56 (2009) 798-809

Bipolar versus Monopolar Transurethral Resection of the

Prostate: A Systematic Review and Meta-analysis of

Randomized Controlled Trials

Charalampos Mamoulakisa, Dirk T. Ubbinkb, Jean J.M.C.H. de

la Rosettea,*

Context:

Incorporation of bipolar technology in transurethral resection

(TUR) of the prostate (TURP) potentially offers advantages over

monopolar TURP (M-TURP).

Objective:

To evaluate the evidence by a meta-analysis, based on

randomized controlled trials (RCTs) comparing bipolar TURP

(B-TURP) with M-TURP for benign prostatic obstruction. Primary

end points included efficacy (maximum flow rate [Qmax],

International Prostate Symptom Score) and safety (adverse

events). Secondary end points included operation time and

duration of irrigation, catheterization, and hospitalization.

Evidence acquisition:

Based on a detailed, unrestricted strategy, the literature was

searched up to February 19, 2009, using Medline, Embase,

Science Citation Index, and the Cochrane Library to detect all

relevant RCTs. Methodological quality assessment of the trials

was based on the Dutch Cochrane Collaboration checklist.

Meta-analysis was performed using Review Manager 5.0.

Evidence synthesis:

Sixteen RCTs (1406 patients) were included. Overall trial quality

was low (eg, allocation concealment and blinding of outcome

assessors were poorly reported). No clinically relevant differences

in short-term (12-mo) efficacy were detected (Qmax: weighted mean

difference [WMD]: 0.72 ml/s; 95% confidence interval [CI],

0.08–1.35; p = 0.03). Data on follow-up of >12 mo are scarce for

B-TURP, precluding long-term efficacy evaluation. Treating 50

patients (95% CI, 33–111) and 20 patients (95% CI, 10–100) with

B-TURP results in one fewer case of TUR syndrome (risk

difference [RD]: 2.0%; 95% CI, 0.9–3.0%; p = 0.01) and one fewer

case of clot retention (RD: 5.0%; 95% CI, 1.0–10%; p = 0.03),

respectively. Operation times, transfusion rates, retention rates

after catheter removal, and urethral complications did not differ

© 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.

a Department of Urology, Academic Medical Center, University of Amsterdam,

Amsterdam, The Netherlands

b Department of Quality Assurance and Process Innovation and Surgery, Academic

Medical Center, University of Amsterdam, Amsterdam, The Netherlands

* Corresponding author. Department of Urology (G4-105), AMC University Hospital,

Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Tel. +31 20 5666030;

Fax: +31 20 5669585. E-mail address: J.J.delarosette@amc.uva.nl

(J.J.M.C.H. de la Rosette).

Please see the references on page 9.

7

Summary of results

B-TURP/plasma is equally as effective as M-TURP in improving the flow rate at 12 months. (WMD: 0.72 ml/s; 95% CI, 0.08–1.35; p=0.03)

Nuhoglu 2006 (n=57)6

Lin 2006 (n=40)7

Seckiner 2006 (n=48)8

De Sio 2006 (n=70)9

Ho 2007 (n=100)10

Erturhan 2007 (n=240)11

Iori 2008 (n=53)12

Bhansali 2009 (n=67)13

Qmax at 12 months (ml/s)

0 5 10 15 20 25 30

M-TURP B-TURP

B-TURP/plasma involves significantly shorter catheterization time than M-TURP. (I2=0.98; sensitivity analysis on subgroup; p<0.00001)

M-TURP B-TURP

Yang 2004 (n=117)14

Singh 2005 (n=60)15

Seckiner 2006 (n=48)8

Kim 2006 (n=50)16

De Sio 2006 (n=70)9

Abascal 2006 (n=45)17

Nuhoglu 2006 (n=57)6

Patankar 2006 (n=103)18

Michielsen 2007 (n=238)19

Erturhan 2007 (n=240)11

Rose 2007 (n=72)20

Iori 2008 (n=53)12

Bhansali 2009 (n=64)13

Catheterization time (hours)

0 20 40 60 80 100 120

B-TURP/plasma shows significantly lower occurrence of TUR syndrome than M-TURP. (RD: 2%; 95% CI, 0–3%; p=0.01)

B-TURP/plasma shows similar long-term urethral complication to M-TURP at 12 months. (RD: 0%; 95% CI, -2–1%; p=0.58)

B-TURP/plasma shows significantly lower occurrence of clot retention M-TURP. (RD: 0%; 95% CI, 1–10%; p=0.03)

Acronyms:

WMD: weighted mean differenceCI: confidence intervalI2: heterogeneityRD: risk difference

M-TURP B-TURP

Events Patient number

Events Patient number

Yang 200414 1 59 0 58 Singh 200515 0 30 0 30De Sio 20069 3 35 0 35Abascal 200617 0 21 0 24Akcayoz 200621 0 21 0 21Patankar 200618 0 51 0 52Kim 200616 0 25 0 25Nuhoglu 20066 0 30 0 27Seckiner 20068 0 24 0 24Erturhan 200711 2 120 0 120Rose 200720 0 34 0 38Michielsen 200719 1 120 0 118Ho 200710 2 52 0 48Iori 200812 0 26 0 27Bhansali 200913 4 33 0 34

Total 13 681 0 681

M-TURP B-TURP

Events Patient number

Events Patient number

Lin 20067 1 18 0 22Patankar 200618 2 51 0 52De Sio 20069 4 35 2 35Ho 200710 2 52 3 48Michielsen 200719 6 120 4 118Erturhan 200711 17 120 2 120Iori 200812 5 26 1 27

Total 37 422 12 422

Please see the references on page 9. The figures and tables were graphically adapted by Olympus. The content has not been changed.

M-TURP B-TURP

Events Patient number

Events Patient number

Urethral stricture

Nuhoglu 20066 0 26 0 24

Seckiner 20068 1 21 2 23

Erturhan 200711 2 120 2 120

Ho 200710 1 52 3 48

Total 4 219 7 215

Bladder neck contracture

Lin 20067 1 18 0 22

De Sio 20069 1 35 1 35

Nuhoglu 20066 0 26 0 24

Erturhan 200711 1 120 0 120

Iori 200812 1 26 1 27

Total 4 225 2 228

Meatal stenosis

Nuhoglu 20066 0 26 1 24

Erturhan 200711 2 120 3 120

Total 2 146 4 144

Cumul. total 10 590 13 587

8

GUIDELINE RECOMMENDATIONS

Summary B-TURP/plasma

· B-TURP is the most widely and thoroughly investigated

alternative to M-TURP.

· Available evidence to date includes 33 RCTs with 3,601

randomized patients in total.

· Three meta-analyses concluded no different efficacy and

preferred safety profile of B-TURP when compared with M-TURP

up to 12 months.

· To date, seven RCTs have mid-term follow-up duration between

18 to 60 months.

· Mid-term results of up to five years show comparable results of

B-TURP in efficacy and safety when compared with M-TURP.

· No individual RCT favors M-TURP.

Summary laser

· Only three RCTs to date provide sufficient follow-up data for 12

months.

· The longest RCT for the 80W KTP laser has a follow-up of only

12 months.

· The longest RCT for the 120W HPS laser has a 36-month

follow-up, but with inferior results in reduction of PSA level and

prostate volume when compared with TURP; the reoperation rate

was significantly higher with PVP.

· No RCTs have been published on the 180W GreenLight laser.

Please see the references on page 9. The figures and tables were graphically adapted by Olympus. The content has not been changed.

TURP/B-TURP LE GR

M-TURP is the current surgical standard procedure

for men with prostate sizes of 30–80 ml and

bothersome moderate-to-severe LUTS secondary of

BPO. M-TURP provides subjective and objective

improvement rates superior to medical or minimally

invasive treatments.

1a A

B-TURP achieves short- and midterm results

comparable with M-TURP.

1a A

B-TURP has a more favorable perioperative safety

profile compared with M-TURP.

1a A

Laser (GreenLight) LE GR

HoLEP and 532-nm laser vaporisation of the

prostate are alternatives to TURP in men with

moderate-to-sever LUTS due to BPO leading to

immediate, objective, and subjective improvements

comparable with TURP.

1a A

The intermediate-term functional results of 532-nm

laser vaporisation of the prostate are comparable

with TURP.

1b A

532-nm laser vaporization should be considered in

patients receiving anticoagulant medication or with a

high cardiovascular risk.

3 B

Level of evidence Type of evidence

1a Evidence obtained from meta-analysis of randomised trials

1b Evidence obtained from at least one randomised trial

3 Evidence obtained from well-designed nonexperimental studies, such as comparative or correlation studies and case reports

Grade Recommendation

A Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomised trial

B Based on well-conducted clinical studies but without randomised clinical trials

EAU guideline 201322 – Transurethral Resection of the Prostate (TURP) and Transurethral

Incision of the Prostate (TUIP)

To put it in a nutshell, B-TURP/plasma has -according to the most recent EAU 2013 guideline on prostate

treatment- equivalent clinical benefit to M-TURP referenced in multiple systematic reviews, based on RCTs.

Moreover, B-TURP/plasma is preferable due to a more favorable safety profile compared with M-TURP. Also,

B-TURP has higher level of evidence and grades of recommendation when compared with laser vaporization.

9

Please see the references on page 9.

Debate over the evidence: B-TURP/plasma has the best available evidence to date (Quotes from Mamoulakis et al. 201323).

Regarding the debate about bipolar transurethral resection of the prostate (B-TURP) versus monopolar

transurethral resection of the prostate (M-TURP), the fact is that we currently have >30 RCTs (>3500

patients) and three recent RCT-based meta-analyses [5]. Indisputably, B-TURP is presently the

most widely used and thoroughly investigated alternative to M-TURP [6].

Pooled results are awaited. However, it should be stressed that no individual RCT favors M-TURP in any

aspect. More than half favor B-TURP in some of the outcomes mentioned above, and the rest

show no difference. Having seven RCTs currently at hand with a follow-up >12 mo, we have

reached acceptable durations to judge the adequacy of B-TURP efficacy and safety comparability with

the predecessor in time. Regarding economic issues, we are still unable to argue decisively.

But can we ignore this ample evidence just because ‘‘the overall quality is not the best,’’ without being

prone to bias? If yes, then what can we infer from much less data on other alternatives to

M-TURP, such as lasers, for which evidence is based on fewer trials with similar methodological

limitations [2]? High-quality international multicenter RCTs are always welcomed; in the modern era of

evidence-based urology, there will always be ‘‘a plea for more.’’ Nevertheless, there comes a time when

we have to decide based on the best available evidence. This is the case for B-TURP versus

M-TURP. Definitely we can decide, and it’s about time!

10

TURIS - SYSTEM CHART

Rotatable continuous-flow resectoscope

Inner sheath

A22040* For 26 Fr. outer sheath

A22041 For 27 Fr. outer sheath

Outer sheath

A22026A 26 Fr., 2 stopcocks, rotatable

A22021A 27 Fr., 2 stopcocks, rotatable

Telescopes 4 mm, autoclavable

A22001A 12° direction of view

A22002A 30° direction of view

WA03200A Light-guide cable, 3 mm, plug type

Continuous-flow resectoscope

Inner sheath

A22040* For 26 Fr. outer sheath

A22041* For 27 Fr. outer sheath

Outer sheath

A22027A 26 Fr., 2 vertical stopcocks, fixed

A22023A 27 Fr., 2 vertical stopcocks, fixed

A22025A 27 Fr., 2 horizontal stopcocks, fixed

Standard resectoscope

A22041* Resection sheath, without irrigation port

Irrigation port

A22051A 1 stopcock, rotatable

A22052A 1 luer-lock connector, rotatable

A22053A 2 horizontal stopcocks, rotatable

A22054A 1 vertical stopcock, fixed

A22055A 1 vertical luer-lock connector, fixed

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A22014A/T.ILL

Resectoscope with intermittent irrigation

A22014* Resection sheath, intermittent irrigation, 24 Fr.

*Add A or T to the article number for the desired obturator: A220xxA standard obturator A220xxT obturator with deflecting tip

HF resection electrodes

WA22301D Loop, 12°, small

WA22305D Loop, 30°, small

WA22302D Loop, 12°, medium

WA22306D Loop, 30°, medium

WA22503D Loop, 12°, large

WA22507D Loop, 30°, large

WA22331D Angled loop, 12° and 30°, small

WA22332D Angled loop, 12° and 30°, medium For a detailed list of electrodes, see our Urology catalogue

WA22351C Roller, 12° and 30°

WA22355C Needle, 12° and 30°, 45° angled loop

WA22521C Band, medium, 12°

WA22523C Band, medium, 30°

WA22557C PlasmaButton, 12° and 30° for plasma vaporisation

WA22558C Angled loop, 12° and 30° for TUEB (transurethral enucleation)

Working elements

WA22366A Working element, active

WA22367A Working element, passive

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MONOPOLAR 1

MONOPOLAR 2

NEUTRAL

FCQM

UNIVERSAL

BIPOLAR

ESG-400

SELECTPROCEDURE

FOOTSWITCH

MENU

Electrosurgical unit

WA00014A HF cable, bipolar, 4 m, for ESG-400

WB91051W HF unit ESG-400

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11

REFERENCES

6 Nuhoglu B, Ayyildiz A, Karagüzel E, et al. Plasmakinetic prostate resection in the treatment of benign prostate hyperplasia: results of one-year follow-up. Int J Urol 2006; 13:21–4.

7 Lin MS, Wu JC, Hsieh HL, et al. Comparison between monopolar and bipolar TURP in treating benign prostatic hyperplasia: one-year report. Mid-Taiwan J Med 2006; 11:143–8.

8 Seckiner I, Yesilli C, Akduman B, et al. A prospective randomized study for comparing bipolar plasmakinetic resection of the prostate with standard TURP. Urol Int 2006; 76:139–43.

9 de Sio M, Autorino R, Quarto G, et al. Gyrus bipolar versus standard monopolar transurethral resection of the prostate: a randomized prospective trial. Urology 2006; 67:69–72.

10 Ho HSS, Yip SKH, Lim KB, et al. A prospective randomized study comparing monopolar and bipolar transurethral resection of prostate using transurethral resection in saline (TURIS) system. Eur Urol 2007; 52:517–24.

11 Erturhan S, Erbagci A, Seckiner I, et al. Plasmakinetic resection of the prostate versus standard transurethral resection of the prostate: a prospective randomized trial with 1-year follow-up. Prostate Cancer Prostatic Dis 2007; 10:97–100.

12 Iori F, Franco G, Leonardo C, et al. Bipolar transurethral resection of prostate: clinical and urodynamic evaluation. Urology 2008; 71: 252–5.

13 Bhansali M, Patankar S, Dobhada S, et al. Management of large (>60 g) prostate gland: PlasmaKinetic Superpulse (bipolar) versus conventional (monopolar) transurethral resection of the prostate. J Endourol 2009; 23:141–6.

14 Yang S, Lin WC, Chang HK, et al. Gyrus plasmasect: is it better than monopolar transurethral resection of prostate? Urol Int 2004; 73: 258–61.

15 Singh H, Desai MR, Shrivastav P, et al. Bipolar versus monopolar transurethral resection of prostate: randomized controlled study. J Endourol 2005; 19:333–8.

16 Kim JY, Moon KH, Yoon CJ, et al. Bipolar transurethral resection of the prostate: A comparative study with monopolar transurethral resection. Korean J Urol 2006; 47:493–7.

17 Abascal Junquera JM, Cecchini Rosell L, Salvador Lacambra C, et al. Bipolar versus monopolar transurethral resection of the prostate: preoperative analysis of the results. Actas Urol Esp 2006; 30:661–6.

References of page 7:

References of page 2:

References of page 3: References of page 8:

References of page 9:

1 Puppo P, Bertolotto F, Introini C, et al. Bipolar transurethral resection in saline (TURis): outcome and complication rates after the first 1000 cases. J Endourol. 2009 Jul; 23(7):1145-9

2 Michielsen DP, Debacker T, De Boe V, et al. Bipolar transurethral resection in saline--an alternative surgical treatment for bladder outlet obstruction? J Urol. 2007 Nov; 178(5):2035-9

3 Geavlete B, Stanescu F, Moldoveanu C, et al. Continuous vs conventional bipolar plasma vaporisation of the prostate and standard monopolar resection: a prospective, randomised comparison of a new technological advance. BJU Int. 2013 Jun 13.

4 Fagerström T, Nyman CR, Hahn RG. Complications and clinical outcome 18 months after bipolar and monopolar transurethral resection of the prostate. J Endourol. 2011 Jun; 25(6):1043-9

5 Fagerström T, Nyman CR, Hahn RG. Degree of vaporization in bipolar and monopolar resection. J Endourol. 2012 Nov; 26(11):1473-7

22 Oelke M, Bachmann A, Descazeaud A, et al. EAU Guidelines on the Treatment and Follow-up of Non-neurogenic Male Lower Urinary Tract Symptoms Including Benign Prostatic Obstruction. European Urology 64, 2013; 118-140.

23 Mamoulakis C, Schulze M, Skolarikos A, et al. Best Available Evidence in 2012 on Bipolar Versus Monopolar Transurethral Resection of the Prostate for Benign Prostatic Obstruction: It’s About Time to Decide! Eur Urol 2013; 63:679–80.

[2] Bachmann A, Muir GH, Wyler SF, et al. Surgical benign prostatic hyperplasia trials: the future is now! Eur Urol 2013; 63:677–9.

[5] Mamoulakis C, Sofras F, de la Rosette J, et al. Bipolar versus monopolar transurethral resection of the prostate for lower urinary tract symptoms secondary to benign prostatic obstruction. Cochrane Collaboration, John Wiley & Sons; 2012. http://dx.doi.org/10.1002/14651858.CD009629.

[6] Oelke M, Bachmann A, Descazeaud A, et al. members of the European Association of Urology Guidelines Office. Guidelines on the management of male lower urinary tract symptoms (LUTS), incl., (BPO) BPO. Paper presented at: 27th European Association of Urology Annual Congress; February 24–28, 2012; Paris, France.

18 Patankar S, Jamkar A, Dobhada S, et al. PlasmaKinetic Superpulse transurethral resection versus conventional transurethral resection of prostate. J Endourol 2006; 20:215–9.

19 Michielsen DP, Debacker T, De Boe V, et al. Bipolar transurethral resection in saline-an alternative surgical treatment for bladder outlet obstruction? J Urol 2007; 178:2035–9.

20 Rose A, Suttor S, Goebell PJ, et al. Transurethral resection of bladder tumors and prostate enlargement in physiological saline solution (TURIS). A prospective study [in German]. Urologe A 2007; 46:1148–50.

21 Akcayoz M, Kaygisiz O, Akdemir O, et al. Comparison of transurethral resection and plasmakinetic transurethral resection applications with regard to fluid absorption amounts in benign prostate hyperplasia. Urol Int 2006; 77: 143–7.

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TURIS – TRANSURETHRAL RESECTION IN SALINE

Specifications, design, and accessories are subject to change without any notice or obligation on the part of the manufacturer.

Postbox 10 49 08, 20034 Hamburg, GermanyWendenstrasse 14–18, 20097 Hamburg, GermanyPhone: +49 40 23773-0, Fax: +49 40 237765www.olympus-europa.com