Supporting healthcare professionals

The evidence is in...Controlled ablation | Proven outcomes2,3 WEREWOLF™

COBLATION™System

*Compared with mechanical debridement.

XR

Faster* patient recovery1

XR

Better*patient outcomes2,3

XR

Safefor use on all joint soft tissue4–10

XR

Lower*total costs11–14

Faster patient recovery*1

Better patient outcomes*2,3

Lower total costs*11–14

Safe for use on all joint soft tissue4–10

Chondral defects in the knee are common15 and can cause significant morbidity16

In a review of over 31,000 knee arthroscopy cases,15 chondral lesions were observed in 63% of cases.

Untreated lesions can lead to a variety of complications:

Treating chondral lesions with mechanical debridement has been associated with:

*Compared with mechanical debridement

COBLATION™ Technology provides a clinically proven alternative to mechanical debridement Using COBLATION Technology for knee procedures delivers:

Pain, swelling, reduced function, increased disability17

Worse outcomes following repair of anterior cruciate ligament tears18

Osteoarthritis,16

which may require a total knee replacement

Average of

lesions per knee2.7Patients with lesions were relatively young:

years old (average age)

4363%

A ‘tearing’ effect on the cartilage, that can lead to further lesion propagation19

Inadvertent removal of adjacent healthy cartilage19

Failure to improve clinical outcomes compared with observation alone20

XR

XR

XR

XR

0

4

6

8

10

Pain

(VA

S) s

core

s

Significantly less knee pain at all follow-up points up to a year after surgery

2

COBLATION

Mechanical debridement

1 year

p=0.014

6 weeks

p<0.001

24 hours

p<0.001

6 hours

p<0.001

Pre-op

p=0.329

Faster patient recovery*1

• Significantly less post-operative knee pain at all follow-up points(6 hours to 1 year)1

• 91% reduction in relative risk of taking NSAIDs for knee pain at 1 year1

• 24% faster return to work1

Significantly less post-operative bleeding

A randomised controlled trial of 60 patients undergoing medial meniscectomy with idiopathic grade III medial-femoral cartilage defects. Patients were randomised into two groups; COBLATION chondroplasty (n=30) or chondroplasty using mechanical debridement (n=30). At 1 year follow-up patients in the COBLATION group experienced:1

*Compared with mechanical debridement. NSAIDs = non-steroidal anti-inflammatory drug ; VAS = visual analogue scale

Mechanical debridement

70.0ml

COBLATION

(p<0.001)

91% reduced relative risk of taking NSAIDs at 1 year

Less physical therapy

COBLATION: 6.4 sessionsMechanical debridement: 9.8 sessions

(p=0.04)

35%COBLATION: 16.4 days

COBLATION 16.4 days

Mechanical debridement21.7 days

faster return to work

were still taking an NSAID

23% 2%

Mechanical debridement

COBLATION

23% 2%

(p=0.026)

24%(p=0.002, mean values presented)

70%relative

reduction

20.8ml

KOOS Tegner Score

COBLATION Mechanical debridement

15.5

71.8 4.5

2.4

11.3

53.2

1.9

3.3

80

0

5

0

p<0.001 p=0.005

Pre-op 4 years Pre-op 4 years

Better patient outcomes*2,3

Patients from this randomised controlled trial were then followed at 4 years2 and 10 years.3 At these medium- and long-term follow-up points, COBLATION™ was superior to mechanical debridement in several outcomes.

Among patients not requiring revision or replacement surgery (n=40), those treated with COBLATION had statistically significant improvements in clinical outcomes compared with mechanical debridement at 4 years2

Slower varus angle progression Varus angle increases were smaller with COBLATION vs the mechanical debridement group (2.3° vs 4.0°; p<0.001) at 4 years2

*Compared with mechanical debridement. KOOS = Knee Osteoarthritis Outcome Score

• Significantly better KOOS and Tegner scores at 4 years2

• 88% reduction in the relative risk of joint replacement surgery at 4 years2

• Significantly extends average time to revision surgery by 2.6 years3

167%increase

COBLATION

Mechanical debridement

4.0° 2.3°

44%increase

Improved clinical outcomes

Varus angle progression is an indirect sign of articular cartilage layer quality as well as of osteoarthritis progression.²

Reduced revisionAt 4 years, a significantly lower proportion of revision procedures for persistent knee problems occurred in the COBLATION™ group than the mechanical debridement group (p<0.01)2

1 Revision arthroscopy

2 Osteotomies

1 Replacement

2 Revision arthroscopies

4 Osteotomies

8 Replacements

COBLATION (n=30) Mechanical debridement (n=30)

(23% vs 60%; p=0.061)

61% reduction in relative risk of revision surgery³

A significantly longer mean time to revision

At 10 years, revision rates remained significantly lower in the COBLATION group compared with the mechanical debridement group (p=0.061)3

COBLATION

Mechanical debridement

p=0.022

7.8

5.2

95% confidence interval

Mean time to revision (years)

(13% vs 47%; p=0.006)

71% reduction in relative risk of revision²

extended average time

to revision

2.6 years

(3% vs 27%; p=0.01142,21*)

88% reduction in relative risk of joint replacement surgery

*Chi-square analysis based on data from Spahn et al.²

Safe for use on all joint soft tissue4–10

• Demonstrated safety for chondroplasty in a study with 824 patients 4

• No cases of osteonecrosis or chondrolysis reported4

• COBLATION™ is indicated for use in the knee on all soft tissue types

Established clinical safetyin a retrospective studyof 840 chondroplastyprocedures using COBLATION technology4

*Figure calculated by capturing the number of COBLATION wands sold from July 2008 to May 2016

Initial procedure

Initial procedure

Second-lookarthroscopy

Second-lookarthroscopy

93.2

205.4107.7Mean lesion size(mm2)

170.2

All lesions (n=25) Tibiofemoral

joint lesions (n=14)

Reduced Lesion Size

Mean lesion size(mm2)

...with the potential to stabilise and fill partial cartilage lesions22

In a second-look arthroscopy study of 25 lesions in 15 patients treated with COBLATION (mean follow-up 10.4 months)22

COBLATION has been used in over 1.5 million knee procedures*

2.2%Post-opcomplications within 6 months 2.7% Re-operations

within 6 months

cases of osteonecrosisor chondrolysis reported0

Low rates of complications and re-operations...

... with zero complications or additional surgeries linked to the use of COBLATION

56% of cartilage defects demonstrated to have partial or complete filling of lesion

of lesions showed no signs of progression

88%

Lower total costs*11–14

COBLATION™ compared with mechanical debridement demonstrates meaningful reductions in physical therapy service use at 6 weeks1 and overall revision rates at 4 years2

• Substantial cost savings at 4 years compared with mechanicaldebridement2,11–14

• Proven value shown in analyses of multiple national payer systems11–14

£1,780 UK13

Based on 2017/2018 UK NHS National Tariff Payment System

Based on the 2016 German Health Costs database

€2,310 Germany12

Based on the 2016 Spanish Health Costs database

€2,073 Spain11

Based on 2017 National Medicare Fee-for-Service Payment data

$3,237 USA14

Using these data, economic analyses for multiple national payer systems was performed comparing COBLATION and mechanical debridement.

In patients with chronic pain due to medial meniscus tear and an International Cartilage Research Society (ICRS) grade III focal chondral lesion, projected 4-year post-surgery total cost savings per patient were:

*Compared with mechanical debridement.

WEREWOLF™ COBLATION™ System with FLOW~IQ™ Technology

* Compares AMBIENT™ SUPERMULTIVAC™ 50 (set point 9) to WEREWOLF™ FLOW 50 Wand (Vac Mode). The results of the in vitro simulation testing have not been proven to predict clinical performance.

FLOW~IQ™ Technology

• Automatically regulates saline outflow withCOBLATION™ energy to optimise performance acrossall tissue types.

• The only platform to control energy output andoutflow suction.

• Enables VAC mode to rinse the joint and cleardebris with a simple push of a button.

FLOW 50™Wand

• Removes tissue approximately 4 times faster thanour market leading 50 degree wand*23

• Removes tissue at lower temperatures than ourmarket leading 50 degree wand*23

• Curved shaft and small tip allow good access.

• 5 modes addresses multiple tissue types andminimises instrument exchanges.

• The controlled plasma fieldproduced by COBLATION™allows for precise removalof soft tissue with minimalthermal damage (100–200 μm)evident in untargeted cartilagetissue.24

• First and only system offeringtwo-zone real-time temperaturemonitoring of intra-articular fluid.

• New two-zone monitoringmeasures both the intra-articularfluid temperature and outflowtemperatures within thehand piece.

• Proprietary circuits detect whena wand is in close proximityto metal and will automaticallysuspend energy delivery.

• When a safe distance isachieved, COBLATION™ energywill automatically resume.

COBLATION™ Technology

SCOPE-SENSING™Technology

AMBIENT™Technology

References

1. 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. 2. Spahn G, Klinger HM, Muckley T, Hofmann GO. Four-year results from a randomized controlled study of knee chondroplasty with concomitant medial meniscectomy: mechanical debridement versus radiofrequency chondroplasty. Arthroscopy. 2010;26:S73–S80. 3. 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. 2016;24:1560–1568. 4. Gharaibeh M, Szomor A, Chen DB, MacDessi SJ. A retrospective study assessing safety and efficacy of bipolar radiofrequency ablation for knee chondral lesions. Cartilage. 2018;9:241–247. 5. Barker SL, Johnstone AJ, Kumar K. In vivo temperature measurement in the subacromial bursa during arthroscopic subacromial decompression. J Shoulder Elbow Surg. 2011;21(6):804–807. 6. Sean NYC, Singh I, Wai CK. Radiofrequency microtenotomy for the treatment of plantar fasciitis shows good early results. Foot Ankle Surg. 2010;16(4):174–177. 7. Wei M, Liu Y, Li Z, Wang Z. Short-term effects of radiofrequency shrinkage treatment for anterior cruciate ligament relaxation on proprioception. J Int Med Res. 2013;41(5):1586–1593. 8. Taverna E, Battistella F, Sansone V, Perfetti C, Tasto JP. Radiofrequency-based plasma microtenotomy compared with arthroscopic subacromial decompression yields equivalent outcomes for rotator cuff tendinosis. Arthroscopy. 2007;23(10):1042–1051. 9. Zini R, Munegato D, De Benedetto M, Carraro A, Bigoni M. Endoscopic iliotibial band release in snapping hip. Hip Int. 2013;23(2):225–232. 10. Liu YJ, Wang Y, Xue J, Lui PP, Chan KM. Arthroscopic gluteal muscle contracture release with radiofrequency energy. Clin Orthop Relat Res. 2009;467(3):799–804. 11. Adeyemi A, Nherera L, Trueman P, Cano J. Cost-effectiveness analysis of COBLATION technology vs. mechanical debridement with a shaver in the treatment of knee cartilage lesions - A Spanish payer perspective. Poster presented at: International Society For Pharmacoeconomics and Outcomes Research; November 4–8, 2017; Glasgow, UK. 12. Adeyemi A, Leo N, Trueman P, Emmermann A. Cost-effectiveness analysis of the use of COBLATION™ knee chondroplasty versus mechanical debridement in German patients. Poster presented at: International Conference on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases; May 25–26, 2017; London, UK. 13. Adeyemi A, Nherera L, Trueman P. Cost-Effectiveness analysis of COBLATION versus mechanical debridement in knee chondroplasty - A UK National Health Service perspective. Poster presented at: International Society For Pharmacoeconomics and Outcomes Research; May 19–23, 2018; Baltimore, MD, USA. 14. Adeyemi A, Nherera L, Trueman P, Delhougne G. Comparing costs and outcomes between COBLATION™ and mechanical debridement in the treatment of knee cartilage lesions - A cost-effectiveness analysis from a US payer perspective. Poster presented at: International Society For Pharmacoeconomics and Outcomes Research; November 4–8, 2017; Glasgow, UK. 15. Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997;13:456–460. 16. Prakash D, Learmonth D. Natural progression of osteo-chondral defect in the femoral condyle. Knee. 2002;9:7–10. 17. Sellards RA, Nho SJ, Cole BJ. Chondral injuries. Curr Opin Rheumatol. 2002;14:134–141. 18. Cinque ME, Chahla J, Mitchell JJ, et al. Influence of meniscal and chondral lesions on patient-reported outcomes after primary anterior cruciate ligament reconstruction at 2-year follow-up. Orthop J Sports Med. 2018;6:2325967117754189. 19. Kosy JD, Schranz PJ, Toms AD, Eyres KS, Mandalia VI. The use of radiofrequency energy for arthroscopic chondroplasty in the knee. Arthroscopy. 2011;27,5:695–703. 20. Bisson LJ, Kluczynski MA, Wind WM, et al. Patient outcomes after observation versus debridement of unstable chondral lesions during partial meniscectomy: The Chondral Lesions And Meniscus Procedures (ChAMP) randomized controlled trial. J Bone Joint Surg Am. 2017;99:1078–1085. 21. Smith & Nephew. Data on file. EO.SPM.PCSgen.001.v1. 22. Voloshin I, Morse KR, Allred CD, Bissell SA, Maloney MD, DeHaven KE. Arthroscopic evaluation of radiofrequency chondroplasty of the knee. Am J Sports Med. 2007;35:1702–1707. 23. Smith & Nephew. Data on file. ArthroCare Flow 50 Wand Vac Mode Comparative Bench-Top Study Report. P/N 53303-01_A. 24. 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.

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