the most extensive portfolio on the market next generation products - - PowerPoint PPT Presentation

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the most extensive portfolio on the market
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the most extensive portfolio on the market next generation products - - PowerPoint PPT Presentation

Jan 27, 2023 262 likes •971 views

Reversed Indications the most extensive portfolio on the market next generation products for anatomic indications on the humeral side www.tornier.com Romain Huon Intl Product Manager www.tornier.com 1 Agenda Aequalis Reversed

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next generation products for anatomic indications on the humeral side

www.tornier.com

Reversed Indications the most extensive portfolio on the market

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Agenda

  • Aequalis Reversed Range: 10 years of success Story
  • Aequalis Reversed II
  • Aequalis Bio RSA
  • Aequalis Reversed Fx
  • Why do we need new members in the Aequalis Reversed Family ?
  • Our new Blockbuster: Aequalis Ascend Flex
  • Our latest innovation: Aequalis Reversed II Line Extension
  • Key success factor: Customer segmentation and differentiation
  • Conclusion
  • Quiz
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Aequalis Reversed Range

Aequalis Reversed Family Aequalis Reversed II Aequalis Reversed I Aequalis Reversed Fx Aequalis Ascend Flex Threaded Post Baseplate Aequalis BIO RSA &/ or

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Aequalis Reversed II

Options!

You have more intraoperative options than any of our competitors allowing the surgeon to accommodate the patient’s unique anatomy.

128 combinations of Reversed II implants 24 combinations of baseplates and spheres 2 approaches accommodated with the extensive Reversed II instruments

+ Reverse Fracture and BioRSA

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Aequalis Reversed II

STANDARD ECCENTRIC 10° TILT

GLENOID SPHERES

STANDARD ECCENTRIC CONSTRAINED 36/42 COMBO

POLY INSERTS

ø29m m

L =25mm

ø25m m

BASEPLATES

L =15mm L = 25mm L =15mm

2 New Spheres 3 New Polys 2 New Baseplates

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  • Feature: 25mm Baseplate
  • Long and short post
  • Benefits:
  • Better fit on smaller glenoids  The smallest Base plate
  • n the Market
  • Lower positioning of sphere on glenoid
  • More Overhang = Less notching

Smallest Base plate on the market

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  • Feature: Long Post Baseplate
  • Benefits:
  • Implantation in native bone
  • Revision surgery
  • BIO-RSA (29mm diam only)

Long Post Base Plate

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  • Feature: Eccentric (+2mm) sphere option
  • Benefits:
  • Less scapular notching
  • Higher Deltoid tension
  • Better R.O.M.
  • Correction of misplaced sphere

Eccentric Sphere Coverage

Remaining inferior bone that may prevent the eccentric sphere from fully seating

Eccentric sphere

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Int Orthop. 2012 Aug;36(8):1647-53. doi: 10.1007/s00264-012-1539-0. Epub 2012 Apr 26.

The clinical and radiographical results of reverse total shoulder arthroplasty with eccentric glenosphere.

Mizuno N, Denard PJ, Raiss P, Walch G.

Eccentric sphere prevents Notching We have the Prove!

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WW usage of the different Sphere types!

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  • Feature: Lateralized (10˚ tilted) sphere option
  • Benefits:
  • Less scapular notching
  • No shoulder ‘deformity’
  • Better R.O.M.
  • More lateralization  Bio RSA

Half Sphere

  • Approx. 4mm

Lateralized sphere

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Is lateralization the answer?

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Yes when it is Boney!

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– Elimination of scapular notching – Increased mobility in rotation – Improved shoulder stability – Improved shoulder contour (as displayed) – Ability to keep the center or rotation (COR) inside the scapula thereby respecting the Grammont design – Easier glenoid preparation

  • Ability to ream with a 29mm reamer and avoid struggling to introduce large (36mm or 42mm)

instruments

  • Improved exposure

BIO RSA Advantages

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BIO RSA really works! We have the Prove:

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81% Grade 0 12% Grade 1 5% Grade 2 2% Grade 3 0% Grade 4

BIO RSA is better than conventional Reversed!

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  • Tornier is offering several solutions to eliminate the most

common “side effect” of RSA

– 25 mm Base Plate – Eccentric Spheres – Lateralized Spheres – Bio RSA

  • With Bio RSA, Tornier has an unique technique to

eliminate most of the challenging aspects of the RSA

  • The use of the eccentric spheres should be more

advertised

Aequalis Reversed & Aequalis Reversed Bio RSA

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Specific Distal Shape

Star-shaped stem provides rotation stabilty Available in size 7, 9, 11, 13 and 15 mm

Window for Grafting

Bone graft window optimizes tuberosity healing

Polished Holes

Allow for attachment in muscle transfers

HA Coated Metaphysis

36mm and 42mm lateralized or constrain inserts for 36 and 42 mm glenosphere

Low Profile

Allows for better positioning of the greater tuberosity

Polished Neck

Reduces risk of suture breakage

Monobloc Design

To avoid unscrewing of the two components

Aequalis Reversed Fx

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Aequalis Reversed Fx

1 2 3 4 5

10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160

1 2 3 4 5

10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160

REVERSED (AAE) HEMI (AAE)

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  • More predictable results
  • If necessary immediate mobilization of elderly patients
  • Best solution for not complaint patients
  • Even with not healed tuberosities, patients can use their

arm properly with almost no pain!

  • Risk of reoperation is minimized
  • The Rev Fx stem is also a perfect revision stem!
  • Strong trend from hemi towards Fx RSA
  • Tornier is still the only company offering a true Reversed fx

Prosthesis

Aequalis Reversed Fx

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Why do we need a new Prosthesis?

  • After 10 years of experience with RSA, we have one of the most

complete Reversed Ranges on the Market

  • On the Glenoid side we have the most complete Reversed range
  • n the market
  • With the experience of the last 10 years, we have seen needs for

evolution on the humeral side and have launched in June of this year our new Blockbuster:

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Designer Group

7 designers are part of this international group.

Dr G. Walch, FR Dr G. Porcellini, IT Dr S. Krishnan, USA Prof P. Boileau, FR Dr B. Edwards, USA Prof M. Loew, GR Prof D. Molé, FR

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Aequalis Ascend Flex: Where are we?

  • FCU in November 2012
  • Launch in June 2013
  • 90 Instruments released since the FCU in OUS/ over 250 WW
  • 850 Implantations in OUS / 3000 WW
  • Ratio Rev/Anat. 1/1
  • Over 90% Press-fit Stems
  • Feedback of the Surgeons: Like the Simplicity of the Instr./Tech.

Stem Design Convertibility All in One System Press-fit stem

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Aequalis Ascend Flex: The revolutionary Evolution!

  • Stem Design
  • Short and long stems
  • Curved / Fin-less Design
  • Female Taper
  • Anti rotational and anatomic flat surface areas
  • Stem Finish
  • PTC uncemented stems
  • Polished cemented stems
  • Epiphysal Offsets
  • Infinite dialability
  • 2 different offset per head or reversed tray
  • System
  • Flexible (Intraoperative choice between all the options)
  • Convertible
  • INSTRUMENTATION!!!!
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Aequalis Ascend Flex: The revolutionary Evolution!

  • AA Flex Global Overview

24 sizes 12 sizes 4 sizes (only B Angle)

Size 1 to 8

Anatomic Reversed

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Aequalis Ascend Flex: The revolutionary Evolution!

  • 8 AA Flex PTC Stem Sizes

70 mm 74 mm 78 mm 82 mm 86 mm 90 mm 94 mm 66 mm 66 mm 70 mm 74 mm 78 mm 82 mm 86 mm 90 mm 94 mm

132.5°

For Reversed configuration only angle B is used! Interesting Facts about the PTC Stems:

  • The Final PTC stem is 2mm thicker than the

compacted Humerus, in Hard bone special care is required and if needed a smaller size stem has to be taken.

  • In special cases, where no cemented stem is

available and the stability of the Press fit is questionable, the PTC stem can be cemented

  • n the distal (not coated) part Downsize

by 2 sizes in case of cementing of PTC Stem!

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Aequalis Ascend Flex: The revolutionary Evolution!

  • AA Flex Cemented Stems: 4 short and 4 long sizes

66 to 90mm 88 to120mm 3 Inclination per short stem size Only Inclination B per long stem size Interesting Facts about the Cemented Stems:

  • The cemented

stem is 1,4mm smaller than the compactors

  • The long

cemented stems are designed for specific Reversed and/or Revision Cases

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Aequalis Ascend Flex: The revolutionary Evolution!

  • AA Flex Trays: High offset and Low offset, infinite dialability
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Aequalis Ascend Flex: The revolutionary Evolution!

  • AA Flex Inserts: In different heights, angle and configuration
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Aequalis Ascend Flex Instrumentation

  • The instrumentation permits a fast and reproducible procedure.

Humeral sets (YKAD251) RVII Glenoid set (YKAD97-98) Aequalis PerFORM set (YKAD210+ 211 or 212 or 213) Humeral sets (YKAD252)

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Aequalis Ascend Flex: The revolutionary Evolution!

  • Stem Design
  • Short and long stems
  • Curved / Fin-less Design
  • Female Taper
  • Anti rotational and anatomic flat surface areas
  • Stem Finish
  • PTC uncemented stems
  • Polished cemented stems
  • Epiphysal Offsets
  • Infinite dialability
  • 2 different offset per head or reversed tray
  • System
  • Flexible (Intraoperative choice between all the options)
  • Convertible
  • INSTRUMENTATION!!!!
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Stem Design

  • Feature: 145° Inclination
  • Benefit: less notching, better

range of motion

130° 140° 155° 155° 145° 135°

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Stem Design

  • Feature: Short Stem
  • Benefit:

– Anecdotal evidence of less blood loss and less postoperative pain – Instrumentation is bone sparing, bone compacting

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Stem Design

  • Feature: Short Stem
  • Benefit: Metaphysal Fixation 

No stress shielding and No boney resorption

In distally fixed press-fit stems the implant takes most of the load and the proximal humerus exhibits resorption on the medial cortex  Stress shielding Log stem vs. Short stem

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Stem Design

  • Feature: Short Stem
  • Benefit:

– In many posttraumatic cases, an adequate reconstruction with conventional stems is not possible, due to the limitations coming from the malunion in the stem zone or/and tuberosities zone – Short stem can resolve this situations

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Stem Design

  • Feature: No Lateral Fin
  • Benefit:

– Easier introduction of the Implant – Better sit of the prosthesis – No risk for fracturing of the lateral cortex of the humerus – Preserving the remaining cuff insertion for better function Fin-less Vs. Finned

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  • Feature: Perfect Metaphysal fit
  • Benefit:

– In many cases, due to the small anatomy of the patient, the conventional metaphysal parts of the implant are to big and this leads to the fracture of the metaphysis which:

– Causes more pain – Leads to less stability, specially for cementless cases – Destroys the remaining cuff insertion and has poorer outcome

– With the Aequalis Ascend Flex, also the smallest patients can be treated, due to the bone sparing design

Stem Design

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Stem Design

  • Feature: Eccentric offset trays /

External Sit of the trays

  • Benefit:

– Specially in cement less fixation, the conventional RSA can have issues for appropriate sit of the prosthesis  can lead to fracture  Can lead to less stability – Due to the external sit of the trays and also eccentric trays, the combined offset can be adjusted and there is no compromise with the fixation.

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Stem Design

  • Feature: Curved Design
  • Benefit:

– Respect the inner geometry of the metaphysis – Optimized Fit and Fill

Stem is able to match the medial and lateral cortex of the humerus Fill the metaphyseal  diaphyseal region with a tapered interface and a high level of correlation

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Stem Design

  • Feature: Flat surface proximally and

distally

  • Benefit:

− Reduces affect of distal retroversion − Adds rotational stability

Flat surfaces to ‘lock’ near bicipital groove Flat surface to counter rotation

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Stem Design

  • Feature: Female Taper
  • Benefit:

− In case of conversion to Reversed (or from hemi to TSA) the female taper allows easier Glenoid access

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Instrumentation

  • Feature: Bone Compacting

Instrumentation

  • Benefit:

− The sounders and compactors do not remove the bone, they compact the bone − The compacted and dense bone supports perfectly the implanted stem

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Concept

  • Feature: Modularity
  • Benefit:

− Surgeon can decide intraoperatively Reversed or Anatomic − Reduced inventory − Reduced Complexity − Happy Surgeon, Happy Nurse

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Concept

  • Feature: Easy Revisable
  • Benefit:
  • In some cases, despite the ability to

convert, the stem has to be removed (e.g. Infection)

  • The neck-less AA Flex allows an easy

removal by using an osteotome to remove the implant-bone interface

  • Stem Removal can be performed in

less than 15min vs. up to 2-3 hours!

EASY vs. Complex

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Aequalis Ascend Flex: The revolutionary Evolution!

  • Stem Design
  • Short and long stems
  • Curved / Fin-less Design
  • Female Taper
  • Anti rotational and anatomic flat surface areas
  • Stem Finish
  • PTC uncemented stems
  • Polished cemented stems
  • Epiphysal Offsets
  • Infinite dialability
  • 2 different offset per head or reversed tray
  • System
  • Flexible (Intraoperative choice between all the options)
  • Convertible
  • INSTRUMENTATION!!!!
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Surgical Tips and Tricks

The humeral cut:

  • Either the 132,5 ° cut guide can be used
  • Or the cut can be performed on the anatomical neck and the final

correction to angle B can be done with the planer

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Surgical Tips and Tricks

Humeral Sounding and compacting:

  • Goal is metaphysal fixation, not cortical Fixation!
  • Use the sounder as maximal possible size
  • Start compacting with 3 sizes below and stop with the size when

the “twist test” gives you an stable prosthesis

Stress shielding? Stress shielding/ Overstuffing?

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Surgical Tips and Tricks

Determination of the Retroversion:

  • Cut on the anatomical neck
  • Use the punch template and be parallel with the cut
  • Use the Depth-Stop and be parallel with the cut
  • The Retroversion Road can be used to do the final control!
  • Make sure for the final implant to be parallel with the cut in any

step of the impaction! (same for Rev. and Anat.)

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Surgical Tips and Tricks

Humeral Punching:

  • Use always the punch
  • The punch enables the prosthesis to sit in its designated and

anatomical position  Best sit of the stem, with the optimal tension of the prosthesis

  • There is also the danger of fracture in hard bone !
  • verlengthening
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Surgical Tips and Tricks

Sizing of the final Implant:

  • The final PTC stem has 2mm bigger diameter than the

compactors

  • Special care is required in hard bone (e.g. Posttraumatic cases)

In hard bones undersize the final implant by one size

e.g. compact size 4 implant size 3

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Surgical Tips and Tricks

Impaction of the final Tray:

  • The impaction stand has two sides
  • It is very important to use the correct side for each size,
  • therwise the stem can be stocked inside the stand!
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Surgical Tips and Tricks

Correct Tray offset:

  • Never be over the greater tuberosity with your offset
  • Try to cover the cut in standard situation
  • Be as central as possible in ap direction
  • Be as far as possible below the cut in tight cases (*)

Excessive lengthening

*

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Surgical Tips and Tricks

Good Tray Position Bad Tray Position

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Surgical Tips and Tricks

Removal of the final insert :

  • Due to the ring fixation, the insert remover must be used
  • The three pegs of the insert remover are placed in the holes of

the tray and the two screws are tightened, so that the clamp completely closes  This pushes the ring together

  • Using an osteotom, the insert can be removed easily
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Surgical Tips and Tricks

Removal of the trial tray:

  • The removal of the trail tray might be challenging in some

situations

  • After untightening the screw, use the clamp and turn the tray

clockwise and anticlockwise while pulling on the tray

  • Turning is key!
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Surgical Tips and Tricks

Adjusting of “B” Angle:

  • Simple trick to keep the angle B on place while fixing the screw
  • Use the head distractor in the way showing in the image below
  • The distractor keeps the angle in B position and the nurse can fix

the screw

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AEQUALIS™ REV II

THREADED POST BASEPLATE

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Aequalis Reversed II Threaded Post Base Plate

  • Reversed II LE Project started in Q1 2013
  • Project contains 2 Phases – Upgrade of Rev II:

– Phase I Threaded Post Base Plate – Phase II Sphere Extension (33, 39 and Titanium)

  • Objective of Phase I is to compete against our main

competitors DJO and Biomet and answers to needs of our Surgeon + Solution for Revision cases

  • Objective of Phase two is to offer smaller Spheres for the

Asian Market and a intermediate Sphere for the global Market + Titanium spheres

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  • Dr. M. Saltzman, USA
  • Dr. A. Green, USA
  • Dr. S. Devinney, USA
  • Dr. P. Collin , FR
  • Dr. L. Neyton, FR

Aequalis Reversed II LE Designer Team

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Double lead thread decreases turns to seat baseplate Cannulated Post Prepared for PSI Technology

2mm Baseplate lateralization eliminates peripheral reaming step.

Proximal plasma spray coating facilitates bone ongrowth for improved long term fixation in cancellous bone / Ability to implant Bio RSA

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Diam 25, L30 Diam 25, L35 Diam 29, L30 Diam 29, L35

Compatible with All Reversed II Spheres 4 Multidirectional Locking Screws

STANDARD ECCENTRIC 10° TILT

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62 Pin Gauge 6.5 Dia. Drill Bit Tap Tap Stopper Base Plate Holder Pin Mat

The steam hole pattern shown on the base will change once the artwork is finished.

Bicortical Guide Pin 8.2 Dia. Drill Bit 5 Dia. Drill Bit 4 Dia. Drill Bit 6 Dia. Drill Bit

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  • Address competitive central screw offerings
  • Application for revision, bone loss, and bone grafting

– Revisions & Bone Loss:

  • Improved fixation into native glenoid bone

– Bone Grafting & BIO-RSA:

  • Potential improvement in compressive forces onto graft
  • Ability to maintain graft compression with threaded fixation

– Increased Tactile Feedback

  • Surgeons can feel the baseplate fixation as they turn the threads

into bone

  • Surgeons using DJO or Biomet baseplate like to achieve fixation

with central threads through exiting cortical bone

Aequalis Reversed II Threaded Post Base Plate

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2014

US LUR Launch

[22 Sets]

NOV DEC FEB MAR APR MAY JUN JUL AUG SEP OCT

Full US Launch

[60 Sets]

EU LUR Launch

[2 Sets]

EU Launch During the NICE Shoulder Course

[25Sets]

LUR LAUNCH

OCT

Aequalis Reversed II Threaded Post Base Plate Launch Plan

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Aequalis Reversed Family Aequalis Reversed II Aequalis Reversed I Aequalis Reversed Fx Aequalis Ascend Flex Threaded Post Baseplate Aequalis BIO RSA &/ or

Key success factor: Customer segmentation & differentiation

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Key success factor: Customer segmentation & differentiation

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Key success factor: Customer segmentation & differentiation

Goal is to:

– Avoid Cannibalization – Avoid Frustration of existing customers – Maximize the efficiency of companies investments – Win new customers – Optimize the turn rate of all sets

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Key success factor: Customer segmentation & differentiation

Reversed I (eventually upgraded):

– Keep to existing happy customers – Low turn customers, who want to have consigment – Reversed Fx customers, just doing fractures! – Price sensitive countries  Bundle

Reversed II

– Keep to existing happy customers – Surgeon who like the Rev over the Flex – Competetive / Existing Surgeon liking Bio RSA

AA Flex

– (High Volume) Competitive Surgeons – High Volume existing Surgeons implanting both Anatomic/Rev. – Customers at risk

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Conclusion

  • Tornier has the most complete reversed range on the

market

  • With Bio RSA, eccentric and tilted sphere and 25mm base

plate, there are several option to reduce the scapular notching

  • Aequalis Reversed Fx is still the one and only real Rev Fx
  • With Rev II LE, Tornier the Rang is completed on the

Glenoid side

  • With the Aequalis Ascend Flex, Tornier is introducing one
  • f the most advanced shoulder system on the market!
  • It is all the question of customer segmentation and

targeting

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Quiz

  • Can the PTC Stem be cemented?
  • In how many eccentric positions can be the tray fixed?
  • Which solutions are the best to avoid the notching on the glenoid

side, rank from best down.

  • What are the advantages of short stem?
  • What are the design advantages of the AA Flex stem?
  • In which angle is the Reversed stem fixed (A, B or C)? What is the

Angle in Degrees?

  • Which surgeon should be targeted with the Rev II LE?