MAKO Surgical Corp. Investor Relations Event AAOS San Francisco - February 8, 2012 Presentations from Featured Surgeons

Transcription

1 MAKO Surgical Corp. Investor Relations Event AAOS San Francisco - February 8, 2012 Presentations from Featured Surgeons Notes: Each of the following presentations contains the views, opinions and surgical results of its respective presenter. MAKO Surgical Corp. expressly disclaims any responsibility for such content. One or more of the presenters set forth below may have a written commercial arrangement with MAKO Surgical Corp. under which such professional may potentially benefit economically. MAKO Surgical Corp

2 TONY NGUYEN ARAM, MD President at AOSMI Founder and Director at Robotic Surgery Center Fairfax, Virginia

3 Practice Private Practice, Advanced Orthopaedics & Sports Medicine Institute, Inova Fair Oaks Hospital Joint Replacements over 500 cases per year Background Research Affiliate with Encore Medical Corporation, Encore 3-D Knee and Minimal Invasive TKR, Research Affiliate with Omni life sciences, Modular THA, 2006-present Assist Aesculap in introducing the short stem bone sparing hip implant, Metha. Mission of Mercy, Head of Orthopaedic Team, Mission abroad in the Philippines Design team member for Encore 3D Knee MIKA (Minimal invasive knee arthroplasty) instrumentation Consultant for MAKO Surgical Corp. Education University of Maryland Baltimore, MD, Cum Laude, AOA Honor Society, 8/88 5/92 University of Pittsburgh Medical Center Orthopaedic Surgery

4 First surgery in August 2010 Performed since over 200 cases Marketing of MAKOplasty Web-based advertising Interactive Web site CBS News Community lectures

5 Tremendous interest from patients Patients are seeking for better solution to their knee and hip problems They want less invasive surgery, less pain, quicker return to work and activity Most do internet research regarding treatment for their problem Younger patients are looking for alternative solution for their arthritis. Not accepting, you are too young for surgery, wait until you re 65

6 Surgeons are skeptical Jaded by poor results with traditional PKR Lack understanding why traditional PKR fails Not familiar with the solutions that MAKOplasty can provide See robots as a gimmick Fear robots may take over their job This however is changing quickly this year and the next five years.

7 2010 One robot, two surgeons trained 2011 Two robots, seven surgeons trained 2012 est. Five robots, 12 surgeons trained Example with davinci robot, every hospital in Northern Virginia has a davinci!

8 My learning curve was about 10 cases, reached average skin to skin time of 65 minutes Now skin to skin of 45 minutes Critical elements to support efficiency in my operating room Training of the operating room personnel to MAKOplasty procedure, including optimization of each surgical step Communication - Same surgical team, constant anticipation of actions Confidence Once trained to the procedure I was able to predict the surgical time and work with 2 operating rooms in parallel. Five cases per room per day.

9 RIO support efficient surgery Reduced instrument set, most set-up done pre-operatively pre-operative planning, intra-operative adjustments Soft-tissue information reduce needs for complex finetuning at the end Leg holder facilitates leg movements No instruments and alignment guides are required for cutting, reducing need to exchange instruments Disposable parts which decrease needs for sterilization Training surgeons to be efficient Set up Team training Build confidence

10 MAKOplasty Robotic Arm Assisted Knee Resurfacing Frederick F. Buechel, Jr. MD MAKOplasty International Destination, Training & Learning Center Naples, Florida USA

11 Disclosures MAKO Surgical Corp. Consultant

12 Today s Presentation Outline About Dr. Buechel My Practice MAKOplasty Impact on My Practice MAKOplasty Impact on My Hospital Why Use Robotics Clinical Examples Our Educational Partnership

13 Frederick Buechel, Jr. MD PRIVATE PRACTICE ROBOTIC JOINT REPLACEMENT CENTER DIRECTOR OF MAKOPLASTY DESTINATION CENTER NAPLES, FLORIDA USA VICE CHAIRMAN DEPARTMENT OF SURGERY PHYSICIANS REGIONAL MEDICAL CENTER NAPLES, FLORIDA (CURRENT) CHIEF OF ORTHOPAEDIC SURGERY NAPLES COMMUNITY HEALTHCARE SYSTEM FELLOWSHIP UNIVERSITY OF PENNSYLVANIA ADULT TOTAL JOINT RECONSTRUCTION RESIDENCY DREXEL UNIVERSITY SCHOOL OF MEDICINE ORTHOPAEDIC SURGERY MEDICAL SCHOOL NEW JERSEY MEDICAL SCHOOL UMDNJ

14 History of Joint Replacement FREDERICK BUECHEL, JR. MD FREDERICK BUECHEL, SR. MD

15 Frederick F. Buechel, Jr. MD

16 MAKOplasty Procedures Frederick Buechel, Jr. MD 424 Procedures

17 MAKOplasty IMPACT ON MY PRACTICE PRACTICE BEFORE MAKOPLASTY ~15 ORTHOPAEDIC SURGEONS IN NAPLES 2 HOSPITAL SYSTEMS WITH 4 HOSPITALS 2 ND LARGEST JOINT VOLUME IN THE U.S. #1 JOINT REPLACEMENT VOLUME IN FLORIDA USED NAVIGATION ON HIP AND KNEE KNEE ARTHROSCOPY TOTAL KNEE REPLACEMENT TOTAL HIP REPLACEMENT 3 PARTIAL KNEE REPLACEMENTS (10 YEARS) PRACTICED AT ONE HOSPITAL SYSTEM PRACTICE AFTER MAKOPLASTY >200 MAKOPLASTY S ANNUALLY INCREASED TOTAL KNEE REPLACEMENT INCREASED KNEE ARTHROSCOPY INCREASED HIP REPLACEMENT NEW HOSPITAL MONTHS OUT IN SCHEDULED PATIENTS

18 MAKOplasty Impact on Hospital HOSPITAL BEFORE MAKOPLASTY LOWER VOLUME MOST OF THE COMMUNITY AT THE OTHER SYSTEM VERY LOW CENSUS DIFFICULT TIME KEEPING MEDICAL STAFF NOT CONSIDERED THE PREMIR HOSPITAL IN TOWN HOSPITAL AFTER MAKOPLASTY 4 NEW ORTHOPAEDIC SURGEONS ON STAFF 6 TRAINED ON MAKOPLASTY MULTIPLE SPECIALTY SURGEONS NOW ON STAFF LARGEST RADIOLOGIST GROUP CHANGED AFFILIATION HOSPITAL IS AT CAPACITY AND DIVERTING PATIENTS NOW A DESTINATION CENTER FOR MAKOPLASTY WITH NATIONAL AND INTERNATIONAL DRAW SO SUCCESSFUL THAT THE PARENT ORGANIZATION HMA PURCHASED 20 ROBOTS AND OUR HOSPITAL RUNS 2 ROBOTS REGULARLY AND RECENTLY PURCHASED A 3 RD

19 Why Are We Using Robots? Partials Makintosh & McKever 1950 s But only ~45,000 Partial Knees are performed Annually Smaller Incisions, Shorter Recovery But, Prior to Robotics Survivorship not as predictable Alignment not predictable No consistent ligament balancing systems More Common to have Early Failures But, Recent Long Term Results show 90% 20 year survivorship when done well by very experienced surgeons. (Richard Scott, MD: Knee Society 2011)

20 But, If Surgeon Installation is not Precise, Improper Balance, Positioning or Tracking Results Accelerating Early Wear of the Bearing or Opposite Knee Compartment

21 How has MAKOplasty Changed the Game? Reduced or Eliminated Surgeon Related Installation Error Provide Patient Specific Implant Placement Optimizing Implant Alignment and Loading Conditions that can Improve the Long Term Performance of the Implants Maintain Healthy Knee Structures & Function while Restoring Each Individual s Natural Knee Kinematics Allows Surgeons to Maximize the use of Minimally Invasive Surgical Techniques Increases Patient Confidence in Surgeon Performance

22 Result: Highly Accurate, Consistently Reproducible Installations Medial Lateral Medial & Patellofemoral

23 Medial MAKOplasty One Week Post Op

24 Medial MAKOplasty 3 weeks Post Op Pre op ROM 5-115, Post op 3 wks ROM 0-120

25 Medial MAKOplasty 7 Weeks Post Op 66 year old male Pre-op ROM wks ROM I just had surgery on April 6, 2010 and was waterskiing on May 30. There is no pain and it feels great. (W. B.)

26 Medial MAKOplasty Snowboarding Post Op

27 Current Educational Partnership Teach at Bio-Skills Training Labs Software, Hardware, Surgical Setup and Operative Technique Surgeon Site Visitation for Potential & New Users Small Group Cadaver Bioskills Remote Tele-Presence Surgery Sony Medical Partner Software Design & Improvement Team Development Training Materials & Comprehensive Patient Management Tools

28 Robotic Joint Replacement Center Naples, Florida Operating Room Cadaver Lab Knee MAKOplasty Cadaver Training Hip MAKOplasty Cadaver Training

29 Robotic Joint Replacement Center Training Sawbones Lab

30 Robotic Joint Replacement Center Conference Room & Tele-Presence Training Room

31 Site Visits: OR Optimization

32 Future & Current Educational Directions Masters Advanced Course Surgeons who have performed the procedure in their hospitals To Improve OR efficiency Learn Advanced Techniques Refine their Skills in Planning and Surgical Approaches Improve Cement Technique Peri-Operative Process Remote / Web Education Tele-Presence Training Live Surgical Web- Based Video Education Improve Web based Patient and Surgeon Resources

33 The Only Way to get to New Heights is by Taking that Next Step! Thank You!

34 Robotic Arm Assistance in THA Amar Ranawat, M.D. Hospital for Special Surgery New York, NY

35 Disclosures MAKO Surgical Corp.: Designer / consultant

36 Experience with MAKOplasty 2.5 years consulting on Application Development cadaveric THAs 19 THA Surgeries w/ MAKO since Jan 2011

37 The Robot: THE WHY?

38 THE CHANGING FACE OF REVISION THA Loose Unstable Infection Fracture Loose Lysis Unstable Fracture Infection 1980 s 90 s 2009

39 Revision in the new millenium #1 Instability #2 Lysis Bozic, et al JBJS 2008 HSS data, 2009

40 Importance of Implant Position Safe zone Lewinnick (described in 78) 40 degrees of abduction degrees of anteversion

41 Anatomic Landmarks: Transverse ligament Sciatic notch Cup Position: A wildcard? Positioners /Guides Pt position key: 40 abduction Mean 40 (range ) Padgett et al, 2005

42 2000 THA s Only 50% of cups within range for both version and abduction

43 Purpose of Navigation: Improve precision and accuracy and hopefully lead to a reduction in problems associated with poor socket placement But is navigation enough?

44 What about Robotics? Navigation is simply a guidance system Robotics: Active: drives itself! ROBODOC Semi-passive Relies on touch! Defines boundaries Surgeon still in control

45 Advantages of Robotics Improved accuracy of bone preparation Precision of delivery

46 Indications for MAKOplasty Osteoarthritis Rheumatoid arthritis Avascular necrosis Femoral neck fractures Protrusio CDH NO CONTRAINDICATIONS

47 Robotic Arm Assisted Patient-specific 3-D pre-op and intra-op planning Guided neck resection Calculated combined version Robotic arm assisted and controlled acetabular reaming Robotic arm assisted and controlled cup placement MAKOplasty Hip Cup Inclination and Version within 5 of your plan Cup Center of Rotation within 2mm of your plan

48 Surgical Workflow 1. Plan & Broach Femoral Stem 2. Combined Anteversion Assessment 3. Intra-operative Cup Planning 4. Robotic Cup Placement 5. Quantified Surgical Report mm 2 mm 1 mm 1 mm

49 Femoral Stem Planning & Broaching Inputs: 3D Templating Neck length is selected based on patient anatomy Outputs: Planned neck resection plane Complete visualization of the planned implant positions Measurement of final broach position

50 Combined Anteversion Assessment Femoral version is difficult to control in a cementless, broach-only, system Therefore, the planned cup version is updated intra-operatively based on the femoral version achieved during broaching Dorr, CORR 2009 Jolles, JoA 2002

51 Intra-operative Cup Planning Inputs: Update Acetabular Plan Size, Center of Rotation Inclination, Version Outputs: Complete visualization of the planned implant positions Predicted hip length Predicted offset

52 Robotic Reaming & Impaction Robotic arm guides both reaming & impaction Real-time numeric & graphical representation of the progression of reaming & impaction

53 MAKO Surgical Corp

54 Robotic Arm Assisted Cup Placement

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56

57 Cadaveric Study 12 fresh frozen cadaveric lower body specimens Pre-operative CT scans for 3D templating of the acetabulum Manual instruments on one side, robotic guidance on the other Post-operative CT scans to determine the cup placement relative to the pre-operative plan

58 Results USING THE ROBOTIC ARM: Anteversion All errors were less than ± 4 Average error 2.16 ± times more accurate than conventional Inclination All errors were less than ±5 Average error 1.91± times more accurate than conventional

59 MAKOplasty Hip Application Results Actual vs. Planned Cup Inclination Cup Version Stem Version Combined Version Hip Length Combined Offset

60 Summary Robotic arm use in THA is a new and exciting concept Barriers to introduction: Cost, time Continued refinement / development

61 Thank you

62 MAKO meeting, San Francisco, February, 2012 Cup pos Harvard -11 MAKOplasty presentation Henrik Malchau, MD, PhD Professor at Harvard Medical School, Vice Chief (Research), Co-director The Harris Orthopaedic Laboratory Attending physician, Orthopedics MGH The Harris Orthopaedic Laboratory Massachusetts General Hospital

63 Disclosure Cup pos Harvard -11 Research support from Zimmer, Smith & Nephew and Biomet Educational and advisory consultant for Smith & Nephew and Biomet Royalty from Smith & Nephew Board member and share holder in RSA Biomedical Inc.

64 Acknowledgment Cup pos Harvard -11 Chris Barr, BSc Shannon Rowell, BSc Kwon Y-M, MD, PhD Freiberg A, MD Rubash H, MD Charles R. Bragdon, PhD

65 Implant position matters Reported problems if abduction>55º Cup pos Harvard -11 Metal on metal: Metallic debris and pseudotumours DePuy recall of 100,000 implants could be an issue for more MoM systems (40% in US 2009) Ceramic on ceramic: Stripe wear and squeaking Metal on highly x-linked poly: Fatigue failures

66 Cup pos Harvard -11 Edge-Loading: Femoral component contacts with the edge of the acetabular component Highly concentrated stresses over a smaller surface area Loss of favourable fluid film lubrication of hard bearings lead to accelerated wear

67 Cup pos Harvard -11 Edge Loading in Hip Bearing Materials Metal on metal: Adverse soft tissue reactions Ceramic on ceramic: Stripe wear and squeaking Metal on HXPE: Fatigue failures

68 Edge-Loading Cup pos Harvard -11 Multi-factorial Surgical Parameters Acetabular component orientation Soft tissue laxity micro-separation Implant Parameters (Cup design) Patient Parameters? Activity/ROM

69 Acetabular Cup Orientation Cup pos Harvard -11 Steep cup inclination decreases cover of the femoral component by the acetabular cup Decreases the area for generation of fluid-film lubrication

70 Cup pos Harvard -11 Cup Design: Dome Geometry Increased thickness at the dome than at the rim Moves the COR of the femoral head out from the center of the acetabular component Increases edge loading risk ASR (Steele JOA 2011)

71 Cup pos Harvard -11 Cup Design: Rim Geometry Abrupt curvature sharpness of the cup edge MoM (Elkins JOR 2012) Larger lip radii reduce edge-loading stress but also decrease coverage CoC (Mak JOA 2011) Chamfer cup edge design reduces edgeloading stress by 60%

72 Future Focus THA Cup pos Harvard -11 Minimizing Edge-Loading Surgical Factor: Optimize Acetabular cup orientation in THA Static vs. Dynamic measurement? Patient-specific ideal orientation Combined version Tools Pre-operative Planning Intra-operative imaging Navigation; Robot-Assisted

73 Kurtz S, Garellick G, Malchau H, Lau E et al.: Future Clinical and Economic Impact of Revision THA and TKA. J. Bone Joint Surg. 2007;89(Suppl. 3): Cup pos Harvard -11

74 Cup pos Harvard -11 The literature Ceramic-on-Ceramic S. A. Sexton, E. Yeung, M. P. Jackson, S. Rajaratnam, J. M. Martell, W. L. Walter, B. A. Zicat, W. K. Walter From Mater Misericordae Hospital, Sydney, Australia

75 74 squeaking hips (73 patients) ~ incidence of 3.1% at 9.5 years FU Four implant position predicted squeaking: high cup inclination, high femoral offset, lateralization of the hip centre high or low cup anteversion Cup pos Harvard -11

76 Cup pos Harvard -11 How is the current surgical standard? Data from the Harris Joint MGH (Level IV data)

77 Outcome analyses MGH Cup pos Harvard -11 IRB approved data repository at MGH. Web based system collecting clinical and radiographic data semi automatically.

78 Cup pos Harvard -11

79 Cup orientation Abduction angle (30-45 ) Cup pos Harvard -11

80 Cup pos Harvard -11 Cup orientation Anteversion angle (5-20 )

81 Purpose Cup pos Harvard -11 Determine if a correlation exists between patient and surgical factors and the positioning of the acetabular cup?

82 Cup pos Harvard -11 Materials and Methods 2063 patients identified from the MGH Harris Registry (1825 with evaluable x-rays postop) Primary THA, Revision THA, or resurfacing performed from Patient factors: Age Gender Laterality of operated hip Body Mass Index Preoperative diagnosis Surgical factors: High/low volume surgeon Surgical approach Head size

83 Cup pos Harvard -11 Materials and Methods Full AP radiograph was measured in Martell Hip Analysis Suite giving abduction and version angles. Acceptable Ranges for this study (consensus between surgeons): Abduction: Version: 5-20

84 Ceramic-on-Ceramic Cup pos Harvard abduction 48 0 anteversion Patient one (red)

85 Metal-on-Metal Cup pos Harvard abduction 35 0 anteversion Patient four (green)

86 Metal-on-Polyethylene Cup pos Harvard abduction 25 0 anteversion Patient two (yellow)

87 Metal-on-polyethylene Cup pos Harvard abduction 44 0 anteversion Patient three (magenta) With thanks to Dr. Huddleston and Dr. Goodman

88 Cup Version (degrees) All Patients, N=1825 Cup pos Harvard Cup Abduction (degrees)

89 Cup Version (degrees) All Patients, N=1825 Cup pos Harvard % 8.5% 4.9% % 37% 23.3% % 7 % 5.2% Cup Abduction (degrees)

90 Cup Version (Degrees) Combined All Abduction Patients (n=1825) and Version Univariate Red and indicates Multivariate revision Analyses (1%) Cup pos Harvard Significant indicators for cup malpositioning were: Surgeon volume (low) Surgical approach (non posterior) Body mass index (obesity) Head size (larger) Cup Abduction (Degrees)

91 Ceramic-on-Ceramic Cup pos Harvard -11 Squeaker, pain, severe osteolysis. Revised 59 0 abduction 48 0 anteversion Patient one (red)

92 Cup pos Harvard -11

93 Cup pos Harvard -11

94 Linear Penetration Depth (d): 1.341mm d y z Cup pos Harvard -11 x

95 Metal-on-Metal Cup pos Harvard -11 Patient three (green) 53 0 abduction 35 0 anteversion 4 years post op. Pain and squeaking. Very high Co and Cr serum ion levels (100 ppb). Revised, severe osteolysis, no soft tissue tumor.

96 CMM Results Cup pos Harvard -11 Measured Distance Between Center of Low Load and High Load Spheres (mm) mm Sphere Center Coordinates X Y Z Diameter (mm) High Load Sphere Low Load Sphere z d y x

97 Metal-on-Polyethylene Cup pos Harvard -11 Recurrent dislocator. Rim fracture of highly cross-linked liner 62 0 abduction 25 0 anteversion Patient one (yellow)

98 Metal-on-polyethylene Cup pos Harvard -11 Rim fracture of highly cross-linked liner. Revised 1 years postop 45 0 abduction 44 0 anteversion Patient two (magenta) With thanks to Dr. Huddleston and Dr. Goodman

99 Cup pos Harvard -11 A question? How bad/good are the MGH results? Benchmarking towards a community hospital

100 Cup pos Harvard -11 Cup Positioning Study at a community Hospital

101 Version (Degrees) Version Community Hospital Cup pos Harvard All Patients MGH (n=1823) Cup Abduction (Degrees) MGH Cup Abduction (Degrees)

102 Revision burden (JBJS(Am) 87-A, July 2005, ) Cup pos Harvard -11 Sweden Medicare >65y ( ) 6,4% US Medicare ( ) 16,9%

103 Cup pos Harvard -11 NJRR Australia Analysis of bearing surface for conventional total hip replacement 196,582 THA s of which 173,582 with primary diagnosis of osteoarthritis reported to the registry up till 31 st Dec 2011

104 Cup pos Harvard -11 Primary Total Conventional Hip Replacement by Bearing Surface (Primary Diagnosis OA) Ceramic/Ceramic vs Metal/Modified poly: 3 month+ Hazard ratio 1.15, p=0.007

105 Cup pos Harvard -11 Primary Total Conventional Hip Replacement by Bearing Surface (Primary Diagnosis OA) MetalMetal Ceramic/Ceramic Metal/Poly Ceramic/Ceramic vs. Metal/Modified poly: 3 month+ Hazard ratio 1.15, p=0.007

106 How should the cup be positioned when Hard-on-Hard bearings are used? Cup pos Harvard -11 Less than 45 o abduction Anteversion between 15 o and 30 o Caution with high femoral off-set and lateralization of the hip centre

107 Cup pos Harvard -11 Take home message If you must use Hard-on-Hard get the position correct Check by intraoperative x-ray or more sophisticated navigation tools.

108 Thank You! Cup pos Harvard -11 The Harris Orthopaedic Laboratory Massachusetts General Hospital