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Top 製品情報 Thulium:YAG laser RevoLix 200W

Thulium:YAG laser RevoLix 200W

販売名

レボリックス 200

一般的名称

ツリウム・ヤグレーザ

証認番号

30200BZX00402000

RevoLixによる治療の利点:

組織深達度が浅い 、優れた止血で安全かつ正確な手術を実現、患者様のQOLの向上に貢献

製品詳細・特徴

  • ツリウム・ヤグレーザの生体組織への吸収性:水分子(生体組織)への吸収性の高いレーザ波長であり、組織内部のエネルギー到達深度は、0.2~0.4mmと浅いため正確でスムーズな切除、核出、浅い凝固層を実現可能にした。
    ⇒水分子は温度上昇による物性の変化がないため、治療効率の低下がない。
    ⇒ピークパワーを抑えた連続波であるため、滑らかな切開、優れた組織蒸散力、高い止血効果を発揮。

RevoLixのツリウムエネルギーは、ヒトの組織に高い割合で存在する水分に吸収され、正確な切除・凝固を実現

Table1: Optical penetration depth of different laser systems [28]

RevoLixツリウムヤグレーザは、KTPレーザと同様の止血特性を維持しながら、より高い組織切除能力を提供 [29]

KTP / グリーンライトはヘモグロビンにより吸収されるため手術への影響は次のように報告されている:

  • 発色団 (ヘモグロビン) が激減 すると、レーザはパワーを失う
  • レーザ組織効果が減少
  • 凝固、血管未発達, 失血した組織や、深くて血管が少ない組織はヘモグロビンが非常に少ない
  • レーザ治療中に組織作用が変化
  • レーザ光からの過剰な熱が周辺および深部組織に伝達
  • 発色団の喪失が、治療の有効性、合併症、複雑さに影響を与える可能性

他術式との利点と違い

TURP (電気メス)との違い

  1. TUR症候群が起こりにくい
  2. 大きな前立腺の治療も可能
  3. 優れた止血作用により抗凝固薬・抗血小板薬服用中の患者の治療も可能

HoLEP(ホルミウムレーザ)との違い

  1. 到達深度は浅く、ピークパワーを抑えた連続波なので生体組織の損傷リスクを低減。
  2. モルセレーターを使用しない術式も可能。
  3. 手技の習得が容易

PVP (グリーンレーザ)との違い

  1. ツリウムヤグレーザは、ホルミウムレーザと同様に水分子に吸収されるため、エネルギー到達深度が浅く、安全な治療が可能。
  2. PVPの治療手技は蒸散のみなのに対し、ツリウム・ヤグレーザは蒸散、切除、止血と多岐にわたる手技を実現

高い安全性と有効性

  • 既存の治療法(TURPなど)と比較し、合併症の発生率は低く、 カテーテル留置期間や入院期間の短縮が可能。
  • 既存の治療法(TURPなど)と同様に、 排尿症状(IPSS、QOL)、排尿機能(Qmax、PVR)を大幅に改善。
  • 凝固層;0.2~0.4㎜、水分子(生体組織)への吸収性の高いレーザ波長であり、組織内部のエネルギー到達深度は浅いため、安全性に優れた設計になっています。

ツリウムvs TURPに関するその他の出版物: Less short term complication rates: „The short-term

✓[Vaporization of the prostate] complication rate with Tm:YAG was […] less than that with TURP.“ [22]

✓Higher efficiency in tissue removal for Thulium-laser in comparison with TURP, shorter post- operative stay [27]

Bach et al., 2010によるツリウムヤグレーザRevolix使用したBPH手術法のアプローチ法の変更

ThuVAP ThuVARP ThuVEP ThuLEP ThuLEP in Oyster technique
hulium laser vaporisation of the prostate 2004 (Mattioli et al., 2008) Thulium laser Vaporesection in Tangerine Technique TmLRP_TT 2005 (Xia, 2009)
Vaporesection 2006 (Bach, Herrmann, Ganzer, Burchardt, & Gross, 2007)
Thulium laser vapo‐enucleation of the prostate 2008 (Bach, Herrmann, et al., 2009) ThuLEP
Anatomical enucleation with Tm:YAG support +‐ mechanical tissue morcellator or mushroom 2009 (Herrmann et al., 2010)
Tm:YAG Oyster
Anatomical enucleation Oyster technique with Tm:YAG support and high power in situ vaporisation 2016 (Herrmann, 2016)

Revolix 200 外科プロトコル、 幅広い治療の選択肢

手技 蒸散切除術 ThuVaRP 蒸散術 ThuVaP 蒸散核出術 ThuVEP 鈍的核出術 ThuLEP
概要 尿道前立腺部から小さな組織片に切除 尿道前立腺部から前立腺組織を蒸散 外科的皮膜付近の溝を蒸散させて腺(2葉または3葉技術)を核出 約100 Wのレーザ出力で中葉を除去。側葉はレゼクトスコープの機械的力を用いて押し出す。
出力設定 (W) 90-200 120-200 90-120 90-120
ファイバー RigiFib 550

RigiFib 800

RigiFib 550

RigiFib 800

RigiFib 1000

RigiFib 550

RigiFib 800

RigiFib 550
治療可能な前立腺サイズ >100 g >120 g 制限なし 制限なし
👍 短いラーニングカーブ
初期治療プロトコル
短いラーニングカーブ
モーセレーション不要
前立腺のサイズ制限なし
最良の臨床結果
前立腺のサイズ制限なし
前立腺の完全除去

適応領域

  • 泌尿器科(膀胱がん、膀胱頸部、腎臓がん、尿管、尿道、前立腺がん、外性器など)
  • 婦人科(外性器、卵管、卵巣、子宮など)
  • 耳鼻咽喉科(扁桃、咽頭、喉頭、軟口蓋、鼻など)
  • 外科(気管支、脳など)

専用ファイバー

最大で15回まで再使用可能でありコスト軽減を実現しなやかで折れにくい

RevoLix200の利点に関する臨床評価の文献

1) Cui, D., Sun, F., Zhuo, J. et al. A randomized trial comparing thulium laser resection to standard transurethral resection of the prostate for symptomatic benign prostatic hyperplasia: four-year follow-up results. World J Urol 32, 683–689 (2014)

2) Xia S.J., Zhuo J., Sun X.W., Han B.M., Shao Y., Zhang Y.N.; “Thulium Lasers versus Standard Transurethral Resection of the Prostate: A Randomized Prospective Trial”; Eur Urol (2008) Jan. 53; 382-390

3) Wei H., Shao Y. Sun F., Sun X., Zhuo J., Zhao F., Han. B., Jiang J., Chen H., Xia S.; “Thulium laser resection versus plasma kinetic resection of prostates larger than 80 ml”; World J Urol (2014) 32; 1077-85

4) Yang Z., Wang X., Liu T.; “Thulium Laser Enucleation Versus Plasma kinetic Resection of the Prostate: A randomized Prospective Trial With 18 Month Follow-up”; Urol (2013) 82 (2); 396-401

5) Zhang F., Shao Q., Herrmann T.R.W.,Tian Y., Zhang Y.; “Thulium Laser Versus Holmium Laser Transurethral Enucleation of the Prostate: 18-Month Follow-up Data of a Single Center”; Urol (2012) 79 (4); 869-874

6) Herrmann T.R.W., Liatsikos E., Nagele U., Traxer O., Merseburger A.S., “EAU Guidelines on Laser Technologies”; Eur Urol (2012) 61 783–795

7) S2e Leitlinie “Therapie des Benignen Prostatasyndroms (BPS)”, 2014, DGU, AK BPS

8) Bach T., Xia S.J., Yang Y., Mattioli S., Watson G.M., Gross A.J., Herrmann T.R.W.; “Thulium:YAG 2 micron cw laser prostatectomy: where do we stand?”; World J Urol 28.2 (2010): 163-168

9) Hauser S., Rogenhofer S., Ellinger J., Strunk T., Müller S.C., Fechner G., “Thulium Laser (RevoLix) Vapoenucleation of the Prostate is a Safe Procedure in Patients with an Increased Risk of Hemorrhage”; Urol Int (2012) 88; 390-394

10) Bach T., Huck N., Wezel F., Häcker A., Gross A.J., Michel M.; “70 vs 120 W thulium:yttrium-aluminium- garnet 2 μm continuous-wave laser for the treatment of benign prostatic hyperplasia: a systematic ex-vivo evalu- ation”; BJU international 106.3 (2010): 368-372

11) Wendt-Nordahl G., Huckele S., Honeck P., Alken P., Knoll T., Michel M., Häcker A., “Systematic Evaluation of a Recently Introduced 2-Micron Continuous Wave Thulium Laser for Vaporesection of the Prostate”; J of Endourol (2008) May 22 (5); 1041-1045

12) Netsch C., Bach T., Herrmann T.R.W., Neubauer O., Gross A.J., “Evaluation of the learning curve for Thulium VapoEnucleation of the prostate (ThuVEP) using a mentor-based approach”; World J Urol, published online 24 June 2012

13) Teichmann H.-O., Herrmann T.R.W., Bach T.; “Technical Aspects of Lasers in Urology”; World J Urol, (2007),

14) Sun F., Han B., Cui D., Zhao F.,Sun X. Zhuo J., Jing Y., Liu H., Xia S., Yang Y., Luo G., Guo F.; “Long-term results of thulium laser resection of the prostate: a prospective study at multiple centers”; 2015 33, 503-508

15) EAU (European Association of Urology), Eds.; “Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO)”; Gravas S. (Chair), Bach T. , Bach- mann A., Drake M., Gacci M., Gratzke C., Madersbacher S., Mamoulakis C., Tikkinen K.A.O., Guidelines Associates: Karavitakis M., Malde S., Sakkalis V., Umbach R.; 2016 March

16) DeCao, H., Wang, J., Huang, Y., LiangLiu, R., JunLei, H., Gao, L., … & Dong, Q. (2015). “Comparison between thulium laser resection of prostate and transurethral plasma kinetic resection of prostate or transurethral resection of prostate” Scientific Reports, 5, 14542.

17) Peng, B., Wang, G. C., Zheng, J. H., Xia, S. Q., Geng, J., Che, J. P., … & Yang, B. (2013). “A comparative study of thulium laser resection of the prostate and bipolar transurethral plasma kinetic prostatectomy for treating benign prostatic hyperplasia” BJU international, 111(4), 633-637.

18) Yan, H., Ou, T. W., Chen, L., Wang, Q., Lan, F., Shen, P., … & Xu, J. J. (2013). “Thulium laser vaporesection versus standard transurethral resection of the prostate: a randomized trial with transpulmonary thermodilution hemodynamic monitoring” Intl J Urol, 20(5), 507-512.

19) Si, J., Gu, B., Chen, Z., & Fu, Q. (2016). “The RevoLix™ 2 μm Continuous Wave Laser Vaporesection for the Treatment of Benign Prostatic Hyperplasia: Five-Year Follow-Up” Photomedicine and laser surgery, 34(7), 297-299.

20) Gross, A. J., Netsch, C., Knipper, S., Hölzel, J., & Bach, T. (2013). Complications and early postoperative outcome in 1080 patients after thulium vapoenucleation of the prostate: results at a single institution. European urology, 63(5), 859-867.

21) Macchione, L., Mucciardi, G., Di Benedetto, A., Butticè, S., & Magno, C. (2013). Efficacy and safety of prostate vaporesection using a 120-W 2-μm continuous-wave Tm: YAG laser (RevoLix 2) in patients on continuous oral anticoagulant or antiplatelet therapy. International urology and nephrology, 45(6), 1545-1551.

22) Vargas, C., García-Larrosa, A., Capdevila, S., & Laborda, A. (2014). Vaporization of the prostate with 150-W thulium laser: complications with 6-month follow-up. Journal of endourology, 28(7), 841-845.

23) Yang, Z., Liu, T., & Wang, X. (2016). Comparison of thulium laser enucleation and plasmakinetic resection of the prostate in a randomized prospective trial with 5-year follow-up. Lasers in medical science, 31(9), 1797-1802.

24) Netsch, C., Stoehrer, M., Brüning, M., Gabuev, A., Bach, T., Herrmann, T. R. W., & Gross, A. J. (2014). Safety and effectiveness of Thulium VapoEnucleation of the prostate (ThuVEP) in patients on anticoagulant therapy. World journal of urology, 32(1), 165-172.

25) http://auanet.mediaroom.com/2018-05-17-AUA-Releases-New-Clinical-Guideline-for-Surgical-Management-of- Lower-Urinary-Tract-Symptoms-Attributed-to-Benign-Prostatic-Hyperplasia

26) American Urological Association. “Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms” (2018, amended 2019) Guideline Statement 20

27) Bach, Thorsten, et al. “Prospective assessment of perioperative course in 2648 patients after surgical treatment of benign prostatic obstruction.” World journal of urology 35.2 (2017): 285-292.

28) Photoselective laser ablation of the prostate: a review of the current 2015 tissue ablation options

29) Wendt-Nordahl, Gunnar, et al. “Systematic Evaluation of a Recently Introduced 2-μm Continuous-Wave Thulium Laser for Vaporesection of the Prostate.” Journal of endourology 22.5 (2008): 1041-1046

 

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REVOLIX 200W-120W LASER

Specialty: The pioneer Laser Urology , Gynecology, ENT surgical technique

The Revolix Thulium laser is the only laser system developed especially for soft tissue surgery. The wavelength of the Revolix laser is 2 microns. This wavelength is absorbed by any tissue by the ubiquitous water molecule.
The Revolix wavelength is similar to the Holmium but the emission mode is continuous instead of pulsed, so the Revolix offers a continuous vaporization effect instead of tearing tissue like the Holmium laser.
The strong tissue absorption of the Revolix wavelength, in any irrigation fluid and water, provides an immediate effect on the tissue, limited penetration, excellent hemostasis and protection against collateral damage.
Revolix combines the benefits of laser surgery in a single device.

Why RevoLix?

  • The RevoLixlaser beam is delivered by flexible laser fibers. Incision and ablation of tissue is similar to CO2 laser technology.
  • The excellent homeostasis of RevoLixmakes it suitable for the treatment of Benign Prostate Hyperplasia (BPH) in patients on anticoagulant medication.
  • RevoLix provides high tissue vaporization rates. Unlike green lasers, there is no decrease in vaporization efficiency, since the absorbent chromophore is water. The incisions are smooth and clean.

Why 2 micron continuous waves?

The 2.0 micron wavelength of the RevoLix is ​​excellent for incision and ablation. It is safe in water irrigation and provides excellent homeostasis. The effect of the laser on the tissue is independent of the vascularization of the tissue.

These properties are due to the efficient absorption effect of the 2.0 micron wavelength by the water molecule, which is omnipresent in any tissue.

Strong absorption and continuous wave emissions provide perfect cuts and soft tissue vaporization with excellent homeostasis. There is no deep penetration or uncontrolled necrosis. Clean cuts and excellent homeostasis are achieved by moving the fiber along the surgical site.

Why is RevoLix Safe?

Its incomparable power allows rapid resection or vaporization of large volumes of tissue. Its speed of section and its quality of hemostasis is superior to any known alternative.

In an aqueous irrigation the effect of the laser on the tissue is restricted to less than 3 mm from the front of the fiber tip. All the most distant tissue is protected by the aqueous solution. The same mechanism protects the tissue and organs adjacent to the cut. Any fabric over a distance of more than 3 mm is not affected by the RevoLix laser. This property eliminates the risk of unintentional tissue damage during laser surgery. Combined with suitable accessories and fibers, the RevoLix  leaves the practitioner the choice of his operating technique in the treatment of prostate pathologies:

HBP protocols

RevoLix offers a variety of HBP options:

  • Vaporection (ThuVaREP),
  • Photovapoenucleation (ThuVEP)
  • Enucleation (ThuLEP).

Suitable for large glands / duration of surgery

For RevoLix there is no limitation on the size of the prostate. Gland volumes of up to 200 ml can be treated. Approximately 1.5 grams of tissue per minute are enucleated.

Ease of use and transport

RevoLix is ​​extremely easy to use, operates quietly and the wide wheels allow it to be transported between different rooms. Revolix can be plugged into any standard electrical outlet. RevoLix has been proving its durability during routine transport between different infrastructures and use by mobile healthcare units.

RevoLix 120 – RevoLix 200

2 different RevoLix models are available. The 120 watt model ideal for enucleation of the prostate and the 200 watt model, which has tissue vaporization increased to more than 3g per minute. Fabric damage is the same on all RevoLix models

Double pedal for cutting and coagulation.

The optional Kix DUO Dual Pedal allows you to switch between cutting and coagulation settings or to control the cutting speed, faster or slower. The single Pedal is also available.

BENEFIT

  • Saline or water is used for irrigation, reducing the risk of Transurethral Resection Syndrome (TURP).
  • Excess laser radiation is absorbed by irrigation and does not affect the fabric more than 3mm from the tip of the fiber. Tissue damage is limited to 0.2 to 1.5 mm, depending on the power of the laser.
  • Excellent visualization. Blood or reflex effects do not affect the view of the surgical site. Color safety glasses keep the colors real. The lens of endoscopes remains splatter-free when used in laparoscopic surgery.
  • No blood loss, no transfusions
  • Quick recovery
  • Reduced hospital stay
  • Less postoperative care needed
  • Shorter catheterization time in the treatment of Benign Prostate Hyperplasia (BPH)
  • Accurate surgery
  • No deep tissue penetration
  • Safe operation
  • Excellent homeostasis
  • Treatment of patients on anticoagulant medication
  • Benign Prostate Hyperplasia (BPH) surgery for ejaculation protection
  • Multidisciplinary

APPLICATION

 Urology

  • VapoProstate resection (ThuVaRP)
  • Prostate vaporization (ThuVAP)
  • Prostate enucleation (ThuVEP)
  • Enucleation of the prostate (ThuLEP)
  • Bladder neck incision
  • Opening restrictions
  • Vaporization and excision of bladder tumors
  • Partial nephrectomy
  • Laparoscopy
  • Laser lithotripsy

Gynecology

  • Excision of polyps
  • Endometriosis
  • Hysterectomy
  • Adhesiolysis
  • Condyloma
  • Myomectomy

ENT

  • Excision of tumors
  • Excision of granulomata
  • Tonsillectomy
  • Stapedectomy
  • UVPP

Pneumology

  • Bronchoscopy
  • Airway recanalization
  • Clearance
  • Tissue coagulation

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