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WEREWOLF COBLATION

System

Overview

More control, proven outcomes 1,2 and inner confidence

The COBLATIONSystem delivers FASTER patient recovery3, BETTER long-term patient outcomes1,2, and is SAFE to use on all soft tissue types4,5,6, compared to mechanical debridement of the knee in clinical studies.

The WEREWOLF System has 5 operating modes to address different soft tissue types and AMBIENT◊  real-time temperature monitoring/over-rides.

2018 first image under Overview on Werewolf page

Five Operating Modes for more control

  • COAG: 2 coagulation settings provide hemostasis during surgery
  • Low: designed and indicated specifically for articular cartilage
  • Medium: designed for dense tissue (Meniscus, Labrum)
  • High: designed for bulk debridement (ACL stump)
  • Vac: designed for keeping a clear view, removes bubbles and debris"


QUANTUM◊  2 Wands

Most QUANTUM 2 Wands are compatible with the WEREWOLF System. The WEREWOLF display screen automatically adjusts to the QUANTUM 2 format when QUANTUM 2 Wands are used.

2018 WEREWOLF Page 

 

Reference
1. Spahn, G, Klinger HM, Mückley T, Hofmann GO. Four-Year Results From a Randomized Controlled Study of Knee Chondroplasty With Concomitant Medial Meniscectomy: Mechanical Debridement Versus Radiofrequency Chondroplasty. Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 26, No 9 (September, Suppl 1), 2010: pp S73-S80. DOI 10.1016/j.arthro.2010.02.030.
2. Spahn G, Hofmann GO, von Engelhardt LV. Mechanical
Debridement Versus Radiofrequency in Knee Chondroplasty with Concomitant Medial Meniscectomy: 10-year Results from a Randomized Controlled Study. Knee Surg Sports Traumatol Arthrosc. DOI 10.1007/s00167-015-3810-6. Epub 2015 October 1.
3. Spahn G, Kahl E, Mückley T, Hofmann GO, Klinger HM. Arthroscopic Knee Chondroplasty using a Bipolar Radiofrequency-based Device Compared to Mechanical Shaver: Results of a
Prospective, Randomized, Controlled Study. Knee Surg Sports Traumatol Arthrosc (2008) 16:565–573. DOI 10.1007/s00167-008-0506-1. Epub 2008 March 8.
4. Gharaibeh, M., Szomor A., Chen D.B. & MacDessi, S.J. 2017. Cartilage. A Retrospective Study Assessing Safety and Efficacy of Bipolar Radiofrequency Ablation for Knee Chondral Lesions. Cartilage. 2017 Apr 1. [Epub ahead of print]
5. Voloshin, I., Morse K.R., Allred, C.D., Bissell, S.A., Maloney, M.D. & DeHaven, K.E. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. American Journal of Sports Medicine. 2007; 35: 1702-1707.
* FDA cleared for use in the knee on all soft tissue types.

 

Manufactured by ArthroCare Corporation, 7000 W. William Cannon Drive, Austin, TX 78735

Clinical Evidence

Level 1 Randomized Controlled Trial

A level 1 randomized controlled trial was carried out over 10 years with 1, 4 and 10 year follow up. The results of these follow-up were published in three studies. One page summaries and references are provided for each.


Spahn et al, 2008:

The first follow-up at 1 year showed faster patient recovery.1

2018 WEREWOLF page

Read the evidence to support:
• Significantly less knee pain at all follow up points (6 hours to 1 year1)
• 91% reduction in the relative risk of taking NSAID drugs at 1 year for knee pain1
• 24% faster return to work1
Spahn et al, 2010:

The second follow-up at 4 years showed better long-term patient outcomes 2.

 2018 WEREWOLF page
Read the evidence to support:
• Significantly better KOOS and Tegner scores at 4 years2
• 88% reduction in the relative risk of joint replacement surgery at 4 years2
Spahn et al, 2016:
The third follow-up at 10 years showed better long-term patient outcomes.3

2018 WEREWOLF page

Read the evidence to support:
• A significantly longer mean time to revision3
• A lower overall rate of revision (23.3% v 60.0%; p=0.061)3
• Significantly superior knee injury and osteoarthritis outcome scores (50.8 v 33.1; p<0.001)3


Additional Studies
In other studies COBLATION technology has been shown to be safe for use on all knee joint soft tissue types. Two of these studies included an 824 patient4 (840 lesions) study and a 15 patient5 (25 lesion second look arthroscopy study.

Gharaibeh et al, 2016:
No reported cases of osteonecrosis or chondrolysis and significant improvements in key outcomes measures.

WEREWOLF page

Read the evidence supporting:
• COBLATION chondroplasty is safe and effective in the knee4
• Low complication rate and no osteonecrosis or chondrolysis reported 4


*Paper States: The use of bRF in treatment of chondral pathologies is a safe modality with low rate of complications. Further studies with long-term follow-up are needed to investigate its efficacy in comparison to other modalities or non-operative treatment. Currently, no large longitudinal studies exist looking at the outcomes for patients treated with bRF for arthroscopic knee chondroplasty.


Voloshin et al, 2007

WEREWOLF page

Read the evidence to support:
• COBLATION chondroplasty is an effective method to treat partial thickness cartilage lesions.5
• On second-look knee arthroscopy, 88% of previously treated partial thickness cartilage lesions showed no signs of progression.5

 


References
1. Spahn, G., Kahl, E., Mückley T., Hofmann G.O. & Klinger, H.M. 2008. Arthroscopic chondroplasty using a bipolar radiofrequency-based device compared to mechanical shaver: results of a prospective, randomized, controlled study. Knee Surgery, Sports Traumatology, Arthroscopy
2. Spahn G,, Klinger H.M,, Mückley T, & Hofmann G.O. 2010. Four-year results from a randomized controlled study of knee chondroplasty with concomitant medial meniscectomy: mechanical debridement versus radiofrequency chondroplasty. Arthroscopy. 2010 Sep;26(9 Suppl):S73-80. 
3. Spahn, G., Hofmann, G.O. & von Engelhardt, L. V. 2016. Mechanical debridement versus radiofrequency in knee chondroplasty with concomitant medial menisectomy: 10-year results from a randomized controlled study. Knee Surgery, Sports Traumatology, Arthroscopy. Volume 24, Issue 5; pp. 1560-68.
4. Gharaibeh, M., Szomor A., Chen D.B. & MacDessi, S.J. 2017.  Cartilage. A Retrospective Study Assessing Safety and Efficacy of Bipolar Radiofrequency Ablation for Knee Chondral Lesions. Cartilage. 2017 Apr 1.
5. Voloshin, I., Morse K.R., Allred, C.D., Bissell, S.A., Maloney, M.D. & DeHaven, K.E. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. American Journal of  Sports Medicine. 2007; 35: 1702-1707.

 

Manufactured by ArthroCare Corporation, 7000 W. William Cannon Drive, Austin, TX 78735

Technology

WEREWOLF with Bubbles callouts

COBLATION is a proprietary technology from Smith and Nephew that is used in the WEREWOLF, QUANTUM and ATLAS products.


COBLATION Technology

  •  Lower temperature than other RF-based technologies,1 with AMBIENT Technology for accurate monitoring of intra-articular fluid.
  • Controlled plasma field allows precise removal of targeted soft tissue while preserving surrounding healthy tissue.2
  • Over 10 million COBLATION procedures since 2008.
  • Proven safe and efficacious4,5,6 — body of clinical/pre-clinical outcomes-based data continues to grow.


FLOW~IQ Technology

  • Automatically regulates saline outflow with COBLATION energy to optimize performance across all tissue types.
      - FLOW~IQ Technology changes the size and intensity of plasma field based on desired tissue effects.3
      - Enables VAC mode to rinse the joint and clear debris with a simple push of a button.7


AMBIENT Technology

  • The only system offering real-time temperature monitoring of intra-articular fluid.
  • New two-zone monitoring measures both the intra-articular fluid temperature and outflow temperatures within the hand piece.
  • When the temperature in the joint space exceeds the user-selected set point, the controller will emit visual and audible alarms.

 
SCOPE-SENSING Technology

  • Exclusive to the WEREWOLF System, SCOPE-SENSING Technology allows surgeons to work more freely around sensitive arthroscopic equipment.
      - Proprietary circuits detect when a wand is in close proximity to metal and will automatically suspend energy delivery.
      - When a safe distance is achieved, COBLATION energy will automatically resume.


FLOW 50 Wand

  • Precisely removes tissue while preserving remaining delicate tissue structures, such as articular cartilage.2
  • Removes tissue up to 4x faster than our current market-leading 50⁰ wand.8
  • Curved shaft and small tip allow access to the most tight spaces in the knee.
  • A single wand with 5 distinct modes addresses multiple tissue types and minimizes instrument exchanges.


References
1. Woloszko J, Kwende M, Stalder K. “COBLATION in Otolaryngology.” Proc. of SPIE, Vol. 341. June 2003.
2. Amiel D, Ball ST, Tasto JP. Chondrocyte viability and metabolic activity after treatment of bovine articular cartilage with bipolar radiofrequency: an in vitro study. Arthroscopy. 2004; 20(5):503-10.
3. Smith & Nephew data on file P/N 69761 page 27.
4. Gharaibeh, M., Szomor A., Chen D.B. & MacDessi, S.J. 2017. Cartilage. A Retrospective Study Assessing Safety and Efficacy of Bipolar Radiofrequency Ablation for Knee Chondral Lesions. Cartilage. 2017 Apr 1. [Epub ahead of print]
5. Voloshin, I., Morse K.R., Allred, C.D., Bissell, S.A., Maloney, M.D. & DeHaven, K.E. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. American Journal of Sports Medicine. 2007; 35: 1702-1707.
6. FDA cleared for use in the knee on all soft tissue types.
7. Smith & Nephew FLOW 50 IFU (P/N 74024).
8. P/N 53303-01

Manufactured by ArthroCare Corporation, 7000 W. William Cannon Drive, Austin, TX 78735

Ordering Information

Ordering Information

Reference Number     Description

72290043*                   WEREWOLF Controller (US)

72290037*                   FLOW 50 Wand

 

*Ordering reference numbers are specific to the US, plese contact your local Smith & Nephew office for ordering information outside of the US.

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This information is intended for health care professionals in the United States only.

Caution: US Federal law restricts the sale of these devices to or on the order of a physician.