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EXPERIENCE OF THE USE OF CADISS® :
The solution for fibrosis in spine revision surgery
Glem
16th December 2021
TABLE OF CONTENT
DEVICE PRESENTATION
EXPERIENCE & CASES IN SPINE REVISION SURGERY
PHARMACOECONOMIC CONSIDERATION
Auxin Surgery 2020 -- CONFIDENTIAL -- Internal use only
1
2
3
THE CADISS®SYSTEM
Device presentation
AuXin Surgery – 2021 - Confidential
AuXin Surgery – 2021 - Confidential
CADISS® SYSTEM
• A COMBINATION BETWEEN
• A drug substance
• Non-cutting dissectors
• SAFE
• CLINICALLY VALIDATED
• QUICK LEARNING CURVE
AuXin Surgery – 2021 - Confidential
• Act on disulfide bonds
The cleavage plane between healthy tissues and pathologic
tissues is often rich in fibrous proteins (type III collagen)
which are cross-linked by disulfide bonds.
• Well-known & safe drug substance :
• mucolytic drug
• uroprotector
MODE OF ACTION
• Mesna (Sodium 2-MercaptoEthaneSulfonate) is a
synthetic thiol compound
• Since 2014, AuXin Surgery has developed a specific
Mesna solution for surgery
Mesna as active principle for surgery for topical application
on tissue: 5% - 1.5g/30ml (0.05g/ml)
PROOF OF PRINCIPLE : the use of mesna
The CADISS® Method has
been tested experimentally
in published randomized
clinical trials in different
indications (more than
1,000 patients).
Chronic otitis
Endometriotic cysts
Oesophagi cancer
Spine revision
Rhinoseptoplasy
Cholecystectomy
Prostatectomy
Side effects
CADISS® helps to preserve
surrounding tissues during
dissection
Selective weakening of adherences
CADISS® reduces the mechanical forces
needed to separate tissues
Relapses
CADISS® facilitates full
withdrawal of pathological
tissues
USEFULNESS OF CADISS®
APPROVED INDICATIONS
SUPPORTED BY CLINICAL TRIALS
EAR SURGERY
MUSCULOSKELETAL
SURGERY
CLASS III MEDICAL DEVICE
APPROVED INDICATIONS
MUSCULOSKELETAL
SURGERY
• Fibrosis resulting from previous
surgery or from trauma
• Idiopathic, post-traumatic or
post-operative perineural
fibrosis (e.g. Dupuytren
disease, etc.)
• Tendon's adherences
Withdrawal of fibrosis
on the dura and on
implants
PRODUCT PORTFOLIO
REMOTE
KIT
MANUAL
KIT
Irrigated & atraumatic
versions of mechanical
instruments
6 different types of
instruments available
for open surgery
- Disk Cannula
- Curved Plate
- Joseph Periosteal
- Hoe-Style Elevator
- Spatula
- Disk Cannula – d 1.5
INSTRUMENTS
CADISS®:
What is that ?
AuXin Surgery – 2021 - Confidential
Cadiss®, what is that ?
2008 Article princeps
Cadiss®, what is that ?
Cadiss®, what is that ?
Cadiss®, what is that ?
Is it too good to be true ?
No limitations in this study ?
?
Cadiss®, what is that ?
Is it too good to be true ?
No limitations in this study ?
?
?
Cadiss®, what is that ?
CADISS®: a new aid for
revision spine surgery with
more selective dissection
AuXin Surgery – 2021 - Confidential
CHWAPI – Dr. Triffaux : Lumbar spine revision
Spinal revision
a real challenge
Cases report
10 Cases – 6 Months – 2 Surgeons
Spinal revision a real challenge
• Spinal revision surgery is complexe and ungrateful
• It’s a succesion of small details
• Good results are not always there
Spinal revision a real challenge
• Pre op evaluation
• Change the approach ?
• Keep the bone contact
• Do not tear off
• Dissolve fibrosis ?
Our experience more than 10 cases
• Ideal case to start:
Posterior Interbody Fusion for late reccurent disc hernia
Our experience more than 10 cases
• Ideal case to start:
Posterior Interbody Fusion for late reccurent disc hernia
Our experience more than 10 cases
• Another case if you are not convinced: try on implants
It’s even easier to see the work of the Cadiss®
Our experience more than 10 cases
• Recurent lumbar disc herniation
• 36 y.o. women
• Surgical cure of right lumbar disc L5S1 herniation -3 y.
• Left radiculalgia improve with conservative treatment
but right S1 radiculalgia increases with failure of
conservative treatment
Our experience more than 10 cases
• Recurent lumbar disc herniation
R L5/S1 L
S1 g
S1 dr
HDL
Ancien abord
Ctscan récidive HDL5S1 droite dd fibrose épidurale post op
S1 g
S1 dr
HDL
HDL
Ancien abord
Our experience more than 10 cases
• Recurent lumbar disc herniation
Our experience more than 10 cases
• Recurent lumbar disc herniation
What the best approach ?
• New discectomy or fusion TLIF ?
• No consensus
Our experience more than 10 cases
• Another case : reccurent lumbar disc herniation
Our experience more than 10 cases
• Recurent lumbar disc herniation
• Our choice: only sequestromy of reccurent L D H
fibrosis
S1 DH
Our experience more than 10 cases
Our experience more than 10 cases
• A bad case :
67 ans y.o. man with comorbidity ++
1992 First arthrodesis L4L5
2008 AMOS Laminectomy L2L3L4 // DH L2L3
2019 Laminectomy Th12 L1 re L1L2L3L4: ADT
2021 Neurogene claudication
Our experience more than 10 cases
• A bad case :
Our experience more than 10 cases
• A bad case :
Our experience more than 10 cases
• A bad case :
Our experience more than 10 cases
• A bad case :
Our experience more than 10 cases
• A bad case :
X
X
X
X
Our experience more than 10 cases
• Our 10 consecutive cases with Cadiss®
6 month period, 10 / 291 = 3,5 % , ADTs 1 with BS
Pharmacoeconomics
consideration in spinal revision
AuXin Surgery – 2021 - Confidential
10 consecutive ADTs study
• The additional direct cost of the ADTs
Study on the hospital bill of 10 consecutive ADTs cases
3 month period : 10 ADTs/ 167 = 6%
• The additional direct cost of the ADTs
Study on the hospital bill of 10 consecutive ADTs cases
Population: Revision 3 , trauma 1 : B2 Th L
10 consecutive ADTs study
• The additional cost of the ADTs
Study on the hospital bill of 10 consecutive IDTs cases
Additional direct cost / ADTS: 1.388 €
10 consecutive ADTs study
CONCLUSION
AuXin Surgery – 2021 - Confidential
TIPS & TRICKS
The CADISS® what can and cannot do
The system facilitates dissection in epidural fibrosis
PREREQUISITE FOR SUCCESS
1. minimize the thicknes of epidural fibrosis
2. take the time for the product to work
3. wash the operative area with PL
TIPS & TRICKS
The CADISS® what can and cannot do
OUTCOMES
1. reduce the operating time
2. reduce the ADTs, reduce bleeding
3. reduce the lenght of hospital stay
It is same as hemostatic products, you always need to do a good
hemostasis : a careful dissection always be done
www.auxin.eu
info@auxin.eu
+32 476 700 214
THANK YOU !

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Epidural Fibrosis GLEM Neurochirurgie ULB Erasme CHU C SPO CHwapi

  • 1. www.auxin.eu info@auxin.eu +32 476 70 02 14 EXPERIENCE OF THE USE OF CADISS® : The solution for fibrosis in spine revision surgery Glem 16th December 2021
  • 2. TABLE OF CONTENT DEVICE PRESENTATION EXPERIENCE & CASES IN SPINE REVISION SURGERY PHARMACOECONOMIC CONSIDERATION Auxin Surgery 2020 -- CONFIDENTIAL -- Internal use only 1 2 3
  • 3. THE CADISS®SYSTEM Device presentation AuXin Surgery – 2021 - Confidential
  • 4. AuXin Surgery – 2021 - Confidential CADISS® SYSTEM • A COMBINATION BETWEEN • A drug substance • Non-cutting dissectors • SAFE • CLINICALLY VALIDATED • QUICK LEARNING CURVE
  • 5. AuXin Surgery – 2021 - Confidential • Act on disulfide bonds The cleavage plane between healthy tissues and pathologic tissues is often rich in fibrous proteins (type III collagen) which are cross-linked by disulfide bonds. • Well-known & safe drug substance : • mucolytic drug • uroprotector MODE OF ACTION • Mesna (Sodium 2-MercaptoEthaneSulfonate) is a synthetic thiol compound • Since 2014, AuXin Surgery has developed a specific Mesna solution for surgery Mesna as active principle for surgery for topical application on tissue: 5% - 1.5g/30ml (0.05g/ml)
  • 6. PROOF OF PRINCIPLE : the use of mesna The CADISS® Method has been tested experimentally in published randomized clinical trials in different indications (more than 1,000 patients). Chronic otitis Endometriotic cysts Oesophagi cancer Spine revision Rhinoseptoplasy Cholecystectomy Prostatectomy
  • 7. Side effects CADISS® helps to preserve surrounding tissues during dissection Selective weakening of adherences CADISS® reduces the mechanical forces needed to separate tissues Relapses CADISS® facilitates full withdrawal of pathological tissues USEFULNESS OF CADISS®
  • 8. APPROVED INDICATIONS SUPPORTED BY CLINICAL TRIALS EAR SURGERY MUSCULOSKELETAL SURGERY CLASS III MEDICAL DEVICE
  • 9. APPROVED INDICATIONS MUSCULOSKELETAL SURGERY • Fibrosis resulting from previous surgery or from trauma • Idiopathic, post-traumatic or post-operative perineural fibrosis (e.g. Dupuytren disease, etc.) • Tendon's adherences Withdrawal of fibrosis on the dura and on implants
  • 11. Irrigated & atraumatic versions of mechanical instruments 6 different types of instruments available for open surgery - Disk Cannula - Curved Plate - Joseph Periosteal - Hoe-Style Elevator - Spatula - Disk Cannula – d 1.5 INSTRUMENTS
  • 12. CADISS®: What is that ? AuXin Surgery – 2021 - Confidential
  • 13. Cadiss®, what is that ? 2008 Article princeps
  • 16. Cadiss®, what is that ? Is it too good to be true ? No limitations in this study ? ?
  • 17. Cadiss®, what is that ? Is it too good to be true ? No limitations in this study ? ? ?
  • 19. CADISS®: a new aid for revision spine surgery with more selective dissection AuXin Surgery – 2021 - Confidential
  • 20. CHWAPI – Dr. Triffaux : Lumbar spine revision Spinal revision a real challenge Cases report 10 Cases – 6 Months – 2 Surgeons
  • 21. Spinal revision a real challenge • Spinal revision surgery is complexe and ungrateful • It’s a succesion of small details • Good results are not always there
  • 22. Spinal revision a real challenge • Pre op evaluation • Change the approach ? • Keep the bone contact • Do not tear off • Dissolve fibrosis ?
  • 23. Our experience more than 10 cases • Ideal case to start: Posterior Interbody Fusion for late reccurent disc hernia
  • 24. Our experience more than 10 cases • Ideal case to start: Posterior Interbody Fusion for late reccurent disc hernia
  • 25. Our experience more than 10 cases • Another case if you are not convinced: try on implants It’s even easier to see the work of the Cadiss®
  • 26. Our experience more than 10 cases • Recurent lumbar disc herniation • 36 y.o. women • Surgical cure of right lumbar disc L5S1 herniation -3 y. • Left radiculalgia improve with conservative treatment but right S1 radiculalgia increases with failure of conservative treatment
  • 27. Our experience more than 10 cases • Recurent lumbar disc herniation R L5/S1 L S1 g S1 dr HDL Ancien abord Ctscan récidive HDL5S1 droite dd fibrose épidurale post op S1 g S1 dr HDL HDL Ancien abord
  • 28. Our experience more than 10 cases • Recurent lumbar disc herniation
  • 29. Our experience more than 10 cases • Recurent lumbar disc herniation What the best approach ? • New discectomy or fusion TLIF ? • No consensus
  • 30. Our experience more than 10 cases • Another case : reccurent lumbar disc herniation
  • 31. Our experience more than 10 cases • Recurent lumbar disc herniation • Our choice: only sequestromy of reccurent L D H fibrosis S1 DH
  • 32. Our experience more than 10 cases
  • 33. Our experience more than 10 cases • A bad case : 67 ans y.o. man with comorbidity ++ 1992 First arthrodesis L4L5 2008 AMOS Laminectomy L2L3L4 // DH L2L3 2019 Laminectomy Th12 L1 re L1L2L3L4: ADT 2021 Neurogene claudication
  • 34. Our experience more than 10 cases • A bad case :
  • 35. Our experience more than 10 cases • A bad case :
  • 36. Our experience more than 10 cases • A bad case :
  • 37. Our experience more than 10 cases • A bad case :
  • 38. Our experience more than 10 cases • A bad case : X X X X
  • 39. Our experience more than 10 cases • Our 10 consecutive cases with Cadiss® 6 month period, 10 / 291 = 3,5 % , ADTs 1 with BS
  • 40. Pharmacoeconomics consideration in spinal revision AuXin Surgery – 2021 - Confidential
  • 41. 10 consecutive ADTs study • The additional direct cost of the ADTs Study on the hospital bill of 10 consecutive ADTs cases 3 month period : 10 ADTs/ 167 = 6%
  • 42. • The additional direct cost of the ADTs Study on the hospital bill of 10 consecutive ADTs cases Population: Revision 3 , trauma 1 : B2 Th L 10 consecutive ADTs study
  • 43. • The additional cost of the ADTs Study on the hospital bill of 10 consecutive IDTs cases Additional direct cost / ADTS: 1.388 € 10 consecutive ADTs study
  • 44. CONCLUSION AuXin Surgery – 2021 - Confidential
  • 45. TIPS & TRICKS The CADISS® what can and cannot do The system facilitates dissection in epidural fibrosis PREREQUISITE FOR SUCCESS 1. minimize the thicknes of epidural fibrosis 2. take the time for the product to work 3. wash the operative area with PL
  • 46. TIPS & TRICKS The CADISS® what can and cannot do OUTCOMES 1. reduce the operating time 2. reduce the ADTs, reduce bleeding 3. reduce the lenght of hospital stay It is same as hemostatic products, you always need to do a good hemostasis : a careful dissection always be done