Reversed Indications the most extensive portfolio on the market

Transcription

1 Reversed Indications the most extensive portfolio on the market next generation products for anatomic indications on the humeral side Huon Intl Product Manager 1

2 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 Romain Huon Intl Product Manager 2

3 Aequalis Reversed Range Aequalis Reversed Family Aequalis Reversed Fx Aequalis Reversed I Aequalis Reversed II Aequalis Ascend Flex Threaded Post Baseplate &/ or Aequalis BIO RSA Romain Huon Intl Product Manager 3

4 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 Romain Huon Intl Product Manager 4

5 Aequalis Reversed II GLENOID SPHERES STANDARD ECCENTRIC 10 TILT 2 New Spheres BASEPLATES 2 New Baseplates ø29m m ø25m m L =15mm L =25mm L =15mm L = 25mm POLY INSERTS STANDARD 36/42 COMBO CONSTRAINED ECCENTRIC 3 New Polys Romain Huon Intl Product Manager 5

6 Smallest Base plate on the market Feature: 25mm Baseplate Long and short post Benefits: Better fit on smaller glenoids The smallest Base plate on the Market Lower positioning of sphere on glenoid More Overhang = Less notching Romain Huon Intl Product Manager

7 Long Post Base Plate Feature: Long Post Baseplate Benefits: Implantation in native bone Revision surgery BIO-RSA (29mm diam only) Romain Huon Intl Product Manager

8 Eccentric sphere Feature: Eccentric (+2mm) sphere option Benefits: Less scapular notching Higher Deltoid tension Better R.O.M. Correction of misplaced sphere Romain Huon Intl Product Manager Eccentric Sphere Coverage Remaining inferior bone that may prevent the eccentric sphere from fully seating

9 Eccentric sphere prevents Notching We have the Prove! Int Orthop Aug;36(8): doi: /s 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. Romain Huon Intl Product Manager

10 WW usage of the different Sphere types! Romain Huon Intl Product Manager

11 Lateralized sphere Feature: Lateralized (10 tilted) sphere option Approx. 4mm Benefits: Less scapular notching No shoulder deformity Better R.O.M. More lateralization Bio RSA Half Sphere Romain Huon Intl Product Manager

12 Is lateralization the answer? Romain Huon Intl Product Manager

13 Yes when it is Boney! Romain Huon Intl Product Manager

14 BIO RSA Advantages 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 Romain Huon Intl Product Manager

15 BIO RSA really works! We have the Prove: Romain Huon Intl Product Manager

16 BIO RSA is better than conventional Reversed! 81% Grade 0 12% Grade 1 5% Grade 2 2% Grade 3 0% Grade 4 Romain Huon Intl Product Manager

17 Aequalis Reversed & Aequalis Reversed Bio RSA 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 Romain Huon Intl Product Manager

18 Aequalis Reversed Fx 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 Window for Grafting Bone graft window optimizes tuberosity healing Polished Holes Allow for attachment in muscle transfers Monobloc Design To avoid unscrewing of the two components Specific Distal Shape Star-shaped stem provides rotation stabilty Available in size 7, 9, 11, 13 and 15 mm Romain Huon Intl Product Manager

19 Aequalis Reversed Fx REVERSED (AAE) HEMI (AAE) Romain Huon Intl Product Manager

20 Aequalis Reversed Fx 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 Romain Huon Intl Product Manager

21 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 on 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: Romain Huon Intl Product Manager 21

22 Designer Group 7 designers are part of this international group. Dr G. Walch, FR Dr S. Krishnan, USA Dr G. Porcellini, IT Prof D. Molé, FR Prof P. Boileau, FR Dr B. Edwards, USA Prof M. Loew, GR Romain Huon Intl Product Manager

23 Aequalis Ascend Flex: Where are we? FCU in November 2012 Launch in June 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 Romain Huon Intl Product Manager 23

24 Stem Design Stem Finish Aequalis Ascend Flex: The revolutionary Evolution! Short and long stems Curved / Fin-less Design Female Taper Anti rotational and anatomic flat surface areas PTC uncemented stems Polished cemented stems Epiphysal Offsets System Infinite dialability 2 different offset per head or reversed tray Flexible (Intraoperative choice between all the options) Convertible INSTRUMENTATION!!!! Romain Huon Intl Product Manager 24

25 Reversed Anatomic AA Flex Global Overview Size 1 to 8 Aequalis Ascend Flex: The revolutionary Evolution! 12 sizes 24 sizes 4 sizes (only B Angle) Romain Huon Intl Product Manager 25

26 66 mm 66 mm 70 mm 70 mm 74 mm 74 mm 78 mm 78 mm 82 mm 82 mm 86 mm 86 mm 90 mm 90 mm 94 mm 94 mm 8 AA Flex PTC Stem Sizes Aequalis Ascend Flex: The revolutionary Evolution! For Reversed configuration only angle B is used! Romain Huon Intl Product Manager 26 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 on the distal (not coated) part Downsize by 2 sizes in case of cementing of PTC Stem!

27 Aequalis Ascend Flex: The revolutionary Evolution! AA Flex Cemented Stems: 4 short and 4 long sizes Interesting Facts about the Cemented Stems: -The cemented stem is 1,4mm smaller than the compactors - The long 66 to 90mm cemented stems 88 to120mm 3 Inclination per short stem size are designed for specific Reversed and/or Revision Cases Only Inclination B per long stem size Romain Huon Intl Product Manager 27

28 Aequalis Ascend Flex: The revolutionary Evolution! AA Flex Trays: High offset and Low offset, infinite dialability Romain Huon Intl Product Manager 28

29 Aequalis Ascend Flex: The revolutionary Evolution! AA Flex Inserts: In different heights, angle and configuration Romain Huon Intl Product Manager 29

30 Aequalis Ascend Flex Instrumentation The instrumentation permits a fast and reproducible procedure. Humeral sets (YKAD251) Humeral sets (YKAD252) Aequalis PerFORM set (YKAD or 212 or 213) RVII Glenoid set (YKAD97-98) Romain Huon Intl Product Manager 30

31 Stem Design Stem Finish Aequalis Ascend Flex: The revolutionary Evolution! Short and long stems Curved / Fin-less Design Female Taper Anti rotational and anatomic flat surface areas PTC uncemented stems Polished cemented stems Epiphysal Offsets System Infinite dialability 2 different offset per head or reversed tray Flexible (Intraoperative choice between all the options) Convertible INSTRUMENTATION!!!! Romain Huon Intl Product Manager 31

32 Stem Design Feature: 145 Inclination Benefit: less notching, better range of motion Romain Huon Intl Product Manager 32

33 Stem Design Feature: Short Stem Benefit: Anecdotal evidence of less blood loss and less postoperative pain Instrumentation is bone sparing, bone compacting Romain Huon Intl Product Manager 33

34 Stem Design Feature: Short Stem Benefit: Metaphysal Fixation No stress shielding and No boney resorption Log stem vs. Short stem 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 Romain Huon Intl Product Manager 34

35 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 Romain Huon Intl Product Manager 35

36 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 Romain Huon Intl Product Manager 36

37 Stem Design 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 Romain Huon Intl Product Manager

38 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. Romain Huon Intl Product Manager

39 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 Romain Huon Intl Product Manager 39

40 Stem Design Feature: Flat surface proximally and distally Flat surface to counter rotation Benefit: Reduces affect of distal retroversion Adds rotational stability Flat surfaces to lock near bicipital groove Romain Huon Intl Product Manager 40

41 Stem Design Feature: Female Taper Benefit: In case of conversion to Reversed (or from hemi to TSA) the female taper allows easier Glenoid access Romain Huon Intl Product Manager 41

42 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 Romain Huon Intl Product Manager 42

43 Concept Feature: Modularity Benefit: Surgeon can decide intraoperatively Reversed or Anatomic Reduced inventory Reduced Complexity Happy Surgeon, Happy Nurse Romain Huon Intl Product Manager 43

44 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 Romain Huon Intl Product Manager 44

45 Stem Design Stem Finish Aequalis Ascend Flex: The revolutionary Evolution! Short and long stems Curved / Fin-less Design Female Taper Anti rotational and anatomic flat surface areas PTC uncemented stems Polished cemented stems Epiphysal Offsets System Infinite dialability 2 different offset per head or reversed tray Flexible (Intraoperative choice between all the options) Convertible INSTRUMENTATION!!!! Romain Huon Intl Product Manager 45

46 The humeral cut: Surgical Tips and Tricks - 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 Romain Huon Intl Product Manager

47 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? Romain Huon Intl Product Manager 47

48 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.) Romain Huon Intl Product Manager 48

49 Humeral Punching: - Use always the punch Surgical Tips and Tricks - 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! overlengthening Romain Huon Intl Product Manager 49

50 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 Romain Huon Intl Product Manager 50

51 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, otherwise the stem can be stocked inside the stand! Romain Huon Intl Product Manager 51

52 Correct Tray offset: Surgical Tips and Tricks - 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 * Romain Huon Intl Product Manager 52

53 Surgical Tips and Tricks Good Tray Position Bad Tray Position Romain Huon Intl Product Manager

54 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 Romain Huon Intl Product Manager 54

55 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! Romain Huon Intl Product Manager 55

56 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 Romain Huon Intl Product Manager 56

57 AEQUALIS REV II THREADED POST BASEPLATE Romain Huon Intl Product Manager

58 Aequalis Reversed II Threaded Post Base Plate Reversed II LE Project started in Q 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 Romain Huon Intl Product Manager

59 Aequalis Reversed II LE Designer Team Dr. M. Saltzman, USA Dr. A. Green, USA Dr. S. Devinney, USA Dr. P. Collin, FR Dr. L. Neyton, FR Romain Huon Intl Product Manager

60 Cannulated Post Prepared for PSI Technology Double lead thread decreases turns to seat baseplate Proximal plasma spray coating facilitates bone ongrowth for improved long term fixation in cancellous bone / Ability to implant Bio RSA 2mm Baseplate lateralization eliminates peripheral reaming step. Romain Huon Intl Product Manager

61 Diam 25, L30 Diam 25, L35 Diam 29, L30 Diam 29, L35 Compatible with All Reversed II Spheres STANDARD ECCENTRIC 10 TILT 4 Multidirectional Locking Screws Romain Huon Intl Product Manager

62 Pin Mat 5 Dia. Drill Bit Pin Gauge 8.2 Dia. Drill Bit 6.5 Dia. Drill Bit Bicortical Guide Pin 4 Dia. Drill Bit 6 Dia. Drill Bit Tap Tap Stopper Base Plate Holder The steam hole pattern shown on the base will change once the artwork is finished. 62

63 Aequalis Reversed II Threaded Post Base Plate 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 Romain Huon Intl Product Manager

64 Aequalis Reversed II Threaded Post Base Plate Launch Plan EU LUR Launch [2 Sets] US LUR Launch [22 Sets] Full US Launch [60 Sets] EU Launch During the NICE Shoulder Course [25Sets] LUR LAUNCH 2014 OCT NOV DEC FEB MAR APR MAY JUN JUL AUG SEP OCT Romain Huon Intl Product Manager

65 Key success factor: Customer segmentation & differentiation Aequalis Reversed Family Aequalis Reversed Fx Aequalis Reversed I Aequalis Reversed II Aequalis Ascend Flex Threaded Post Baseplate &/ or Aequalis BIO RSA Romain Huon Intl Product Manager 65

66 Key success factor: Customer segmentation & differentiation Romain Huon Intl Product Manager 66

67 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 Romain Huon Intl Product Manager 67

68 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 Romain Huon Intl Product Manager 68

69 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 of the most advanced shoulder system on the market! It is all the question of customer segmentation and targeting Romain Huon Intl Product Manager 69

70 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? Romain Huon Intl Product Manager