*Saleh Baeesa1, MB.ChB, FRCSC, FAANS., Márton Rónai 2, M.D. & Jan Štulík 3, M.D. P h.d.

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1 Quality of life after Cervical Disc Arthroplasty To Treat Degenerative Disc Disease: Two Year Results of an International Prospective, Multicenter, Observational Study (NTC ) *Saleh Baeesa1, MB.ChB, FRCSC, FAANS., Márton Rónai 2, M.D. & Jan Štulík 3, M.D. P h.d. 1. Division of Neurosurgery, King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2. Orthopedics, Buda Health Center, Budapest,Hungary, 3. Center for Spinal Surgery, University Clinic Motol, Czech Republic EuroSpine 2015 Friday, September 4, 2015, 14:

2 Study Synopsis Purpose Collect information on the patient outcomes after Prestige disc implant Design Prospective, non- interventional, multi- center, post- market study 15 enrolling sites (Czech Repubic, Hungary, Kuwait, Poland, Saudi Arabia, Serbia and Slovakia) 194 enrolled patients, 2 years follow- up (discharge, 3, 6, 12 & 24 months) Main Inclusion/Exclusion Criteria Inclusion criteria Patient must be willing to sign a Patient Data Release Form Patient with DDD to receive the Prestige disc according to I nstructions For Use Exclusion criteria Patient has not reached age of legal consent Patient has diabetes, patient has BMI > 35 Patient does not have affected disc between C3/C4 and C6/C7 Patient with instability of cervical spine Patients who were receiving extensive decompression

3 Study Endpoints Endpoint Primary Parameter QoL (EQ- 5D and NDI) Timepoint Up to 24 months Duration of pain prior to enrollment Drug regimen Intervertebral disc space of the affected and adjacent disc levels Secondary Implantation data: - size of cervical disc prosthesis - operation time - blood loss Up to 24 months Heterotopic Ossification Tertiary Additional Adverse Events Up to 24 months Hospital stay and Return to work Discharge Surgeon perception of outcomes Up to 24 months

4 Patient Accountability

5 Baseline Characteristics Total Number of Patients (N) 190 Gender (N, % females) 127, 6 6.9% Age at surgery (in years, Mean ± SD, range) (±8.6, ) 25.6 (±4.1, ) BMI (Mean ± SD, range) Duration of pain prior to baseline visit Vascular 14% Cardiac 11% Musculoskeletal Other metabolic/endocrine Dermatological 10% Gatro- intestinal 9% Psychiatric 5% 41 (21.6%) Other neurological 4% 71 (37.4%) Pulmonary 3% Genitourinary 2% Stroke/TIA 0% Other 8% * No pain 0-3 months prior to baseline 3-6 months prior to baseline 6-12 months prior to baseline > 12 months prior to baseline Patients with previous c ervical surgeries Patients with c oncomitant diseases at baseline Concomitant diseases present at baseline Allergies 19% 1 (0.5%) 35 (18.4%) 42 (22.1%) 11 (6.1%) 134 (70.5%) 10% 2% Primary indication

6 Surgery Data Number of discs implanted by level and disc size Two levels 16.3% Disc size One level 83.7% Implanted levels Implanted level Surgery details Operative time 87.1 ± 45.2 min (Min- Max: min) Blood loss 43.8 ± 64.4 ml (Min- Max: ml)

7 Improved EQ- 5D INDEX and VAS 3 to 24 months EQ- 5D index m EQ- 5D VAS m m Difference* from baseline is statistically significant for all F Us (P < 0.001) * Differences are calculated only for patients w ith data available both at baseline and the applicable F U m

8 Improved EQ- 5D individual dimensions

9 Improved Neck Disability Index NDI success** 3 m onths (N = 1 32) 6 m onths 12 m onths 24 m onths (N = 6 1) (N = 8 5) (N = 1 07) Yes 83.3% 83.6% 87.1% 72.0% No 16.7% 16.4% 12.9% 28.0% ** NDI success defined as 10% improvement from baseline (Riddle & S tratford 1998) m mo Difference from baseline is statistically significant for all F Us (P < 0.001). Differences w ere calculated only for patients w ith data available both at baseline and the applicable F U

10 Intervertebral Disc Space Average Disc Height (mm) Increased at 3 months maintained at 24 months m m

11 Heterotopic Ossification Secondary Endpoint Grade 0 Clinical Sign No HO present. I HO detectable in front of the vertebral body but not intervertebral space. II HO growing into the disc space. Possible affection of the function of the prosthesis. III Bridging ossifications which still allow movement of the prosthesis. IV Complete fusion of the treated segment without movement in flexion / e xtension. *Grading: Mehren C, Suchomel P, et al.: Heterotopic ossification i n total c ervical artificial disc replacement. Spine, Nov 15;31(24):

12 Adverse Events Number of Events Action t aken (n = 63) 44 patients (23.1%) 63 events Invasive intervention Serious Adverse Events 7 patients (3.7%) 8 events Emergency Room visit 1 (1.6%%) Medication change 15 (23.8%) Serious Adverse Device Events 2 patients (1.0%) 2 events Diagnostic testing 25 (39.7%) Other 12 (19.0%) No action taken 16 (25.4%) Adverse Events Relation to disc, instrumentation and/or procedure (n = 63) Related 7 ( 11.1%) Not related 41 ( 65.1%) Unknown 15 ( 23.8%) Prestige disc explanted 14 (22.2%) 1 (1.6%) * percentages sum up to more than 100% as multiple answers were possible

13 Time to Discharge and Return to Work Time to discharge (n = 177) Mean 4.8 ± 12.9 days Min- Max days Time to return to work (n = 86) Mean(±SD) 114 ± days Min- Max days Work status at baseline (n = 189) Return to work after surgery (n = 175)

14 Great majority (88.4%) Surgery Outcome Indicated as Excellent, Very good or Good Surgeon s perception of surgery outcome for the patient

15 Conclusions Two Years Follow Up The first real world study to show safety and effectiveness in the Central & Eastern Europe and Middle East Prestige Cervical Disc Replacement To Treat Degenerative Disc Disease International P rospective, Multicenter, Observational Study PRO I mprovements (NDI, EQ- 5D, individual dimensions) reached at 3 months post Prestige cervical disc implantation Overall success (PROs improved outcomes) are maintained up to 2 years Acceptable AE rates, surgical intervention rates comparable with other clinical trials

16 Disclosures All authors are PRESTIGE study clinical trial participants and consultants for Medtronic. This clinical trial was sponsored by

17 Acknowledgements PRESTIGE study investigators Drs Jan Štulík, Márton Rónai, Saleh Baeesa, Bruno Rudinský, Daniel Zarzycki, Dariusz Latka, Jiri Matejka, Pawel Lis, Pawel Jarmuzek, Pawel Baranowski, Danilo Radulovic, Djordje Jajic, Ivan Stefanovic, Dariusz Larysz, Abdel- Razzaq Al- Obaid All patients who participated in this study, staff who contributed to the conduct of the study and Medtronic Spinal & Biologics