UNLEASH™ MIS TLIF SOLUTIONValue Analysis Brief

2

Epidemiology of lumbar degenerative conditions and lumbar fusions

PROCEDURE Burden

62,000+Transforaminal Lumbar Interbody Fusion (TLIF)

procedures were estimated to occur in Europe in 2018.2

• Annually, 266 million patients are diagnosed with low back pain due to lumbardegenerative disease worldwide.1

• Over 62,000 transforaminal lumbar interbody fusion (TLIF) procedures wereestimated to occur in Europe in 2018.2

• The average cost of a lumbar fusion procedure in some European regions is over€10,000.3

• Minimally invasive surgery (MIS) for spinal fusion is increasing for the treatment oflumbar degenerative disease.2

• MIS TLIF is associated with lower morbidity (i.e. blood loss, surgical complications,wound infections, hospital length-of-stay)4-7 and lower total hospital direct costscompared with open TLIF.4; 5; 7

High instrument variability and unnecessary instrument use can be an important source of burden in MIS TLIF procedures8; 9

€50.43Sterilizing and packaging cost of up to €50.43 per

instrument tray.10

• Across surgical specialties many surgical instruments go unused which may bedue to ineffectively predicting those necessary to complete a procedure.8

• High instrument variability, as well as unnecessary surgical instrumentsterilization, packaging, transport, unwrapping, and reorganization drives upcost and carries implications for patient safety.9

• In a US study focused primarily on MIS spine procedures, the reduction ofunnecessary instrument (and tray) use led to the elimination of over $60,000in wasted processing of instruments in one year.9 A European study estimatedthe cost of processing reusable instruments as up to €50.43 per tray containingmore than 70 items.10

• Overall, MIS TLIF is a common procedure that can be complex,11

variable in length,12 and require multiple instruments/instrument passes.13

Given this burden, there are opportunities for improvement in MIS TLIF procedures.

3

THE UNLEASH™ Solution

The UNLEASH™ Solution helps to streamline and improve the 3 main stages in MIS TLIF*

* The UNLEASH Solution is indicated for lumbar arthrodesis, transforaminal interbody technique, including discectomy to prepare interspace and insertion of interbody biomechanical device with integral instrumentation for device anchoring.

† Comparative cadaver evaluation (non-clinical testing) where CONCORDE Clear MIS Discectomy Device and traditional discectomy instrumentation were randomized at surgeon and vertebral level.

Engineered to provide immediate mechanical

stability and to promote rapid and long-lasting

biological fixation with supporting bone.14-18

Eliminates the need for guidewires, Jamshidi needles

and pedicle preparation instruments which enables surgeons to target pedicles

and insert screws in one single instrument pass.19

CAGE PLACEMENT

PROTI 360° Titanium Integrated Technology

– Accelerated osteoconductionand bone matrix formation onthe titanium integrated cagesurfaces14

– Designed to prevent delaminationdue to enhanced bonding strengthbetween PEEK and titanuim15

– Greater surface area forosteoblast integration14

DISCECTOMY SCREW PLACEMENT

– Advantageous technique forpedicle screw placement

– One-tool screw insertion withcortical fix fenestrated screwthread option

– Single integrateddisposable stylet

– Streamlined instrumentand implant set

Designed to provide more efficient disc clearing

and endplate preparation than using standard discectomy

tools.†

– Optimized for MIS(5 mm diameter)

– Variable cutting tip sizes– 360° wall suction connection– Allows visualization

of collected disc material– No capital equipment needed– Sterile packed single use device

VIPER PRIME™ SystemCONCORDE® Clear MIS Discectomy Device

89%reduction in

instrument passes (p<0.001).20

2X Volumetric Removal for

Experienced CONCORDE Clear MIS Discectomy Device Users20

The results of a cadaveric study indicated greater

volumetric removal with the CONCORDE Clear system.20;*

Osteoblast functions, including bone matrix production, are

enhanced on surfaces that are most similar to bone.14

Bonding strength approximately twice that of regulatory coating

requirement and 30% more compared to other Ti coated

PEEK devices.15

CREATE

3

4

5

6

7

8

9

Less Procedure Steps

Insert Screw

Remove Driver

Insert Rods

Insert Set Screws

1

3

5

2

4

6

Make Incision

Target Pedicles

Previous Steps:

Insert Jamshidi Needle

Insert Guidewire

Remove Jamshidi Needle

Insert Tap

Remove Tap

Start Screw

Remove Guidewire

0

10

20

30

40

50

60

70

Inst

rum

ent

Pass

es

Control CONCORDE Clear (n=9) (n=9)

Reduced Instrument Passes When Compared to

Standard Discectomy Instruments.*

Greater Volumetric Removal

4

CLINICAL Value

DISCECTOMY CAGE PLACEMENT SCREW PLACEMENT

INTEGRATE

STIMULATE

7When compared to the

Traditional Jamshidi/Guidewire Technique

with VIPER 219.

* Note, the results are based on a cadaveric study and may not necessarily be indicative of clinical performance. ° Devices are MR conditional refer to instructions for use for detailed MR labeling.

The VIPER Prime System was Designed to Improve

Guidewire and Workflow Management in the OR.

Osteoblast Adhesion

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%Other Ti Coating

FDA Guidance Requirment

PROTI 360° Porous Peek

Tens

ile S

tren

gth

(MPa

)

Titanium/PEEK Bonding Strength15

Static Tensile Strength

Nano Surface Features

Favorable environment for bone growth.16

The CONCORDE Clear System demonstrated a a 76% reduction in discectomy time when

compared to traditional discectomy tools in a cadaveric ethnography study

(14.96 min vs. 3.64 min, p<0.001).*21

The VIPER PRIME System demonstrated a 47% decrease in mean time for

preparation, tapping and screw insertion (PTS) when compared to the VIPER 2® MIS

Spine System (22.22 min vs. 11.85 min, p<0.001).23

76%reduction in

discectomy time (p<0.001)*

47%reduction in

PTS time (p<0.001)

0

5

10

15

20

25

Mea

n T

ime

(Min

) 14.96 min

Control(n=9)

3.64 min

0

5

10

15

20

25

Mea

n T

ime

(Min

)

Preparation/Tapping/Screw Insertion (PTS)

22.22 min

Control (n=14)

VIPER Prime System(n=15)

11.85 min

5

DISCECTOMY SCREW PLACEMENT

PROCEDURE EfficiencyThe UNLEASH Solution has the potential to improve MIS TLIF procedure efficiency through a

reduction in procedure steps and screw placement time.

• The average total MIS TLIF procedure time is close to 2 hours,4,7,21 with high variability in procedure timecomponents.12

• A study of discectomy and fusion patients demonstrated that prolonged anaesthesia time significantly increasedthe likelihood of overall complications (Odds Ratio (OR) = 2.71, p < 0.05), venous thromboembolism (OR = 2.69,p < 0.05), length of stay (OR = 3.61, p < 0.0001), and return to the operating room (OR = 2.92, p < 0.01).22

Combined, the UNLEASH Solution may provide procedural time savings in both discectomy and screw placement. A reduction in procedure time may help reduce

anaesthesia time. Additionally, the UNLEASH Solution enables a reduction in instrument trays in the OR compared to current product offerings.°†

Discectomy

Concorde Clear (n=9)

4FEWER

instrument trays^

with the UNLEASH Solution°†

* Note, the results are based on a cadaveric study and may not necessarily be indicative of clinical performance. ^ Instrument trays are counted as each individual tray/level within an instrument set.° The UNLEASH Solution includes CONCORDE Clear MIS Discectomy Device (0 trays), the PROTI 360° Titanium Integrated Technology (1 tray), and the VIPER PRIME System (1 tray). †

Current product offerings include Standard Discectomy Instruments (1 tray), CONCORDE Bullet System (2 trays), and the VIPER 2 MIS System (3 trays).

* Study size =18 (9 cases per group). Time savings were stasticially signifivant (p<0.001). Cadaveric results may not necessarily be indicative of clinical performance.

° Study size = 29 (14 controcl, 15 experiment). Time savings were statistically significant (p<0.001).† Assumes an OR cost per minute of €14.70 (average based on data from Italy, Germany, the Netherlands, and the UK)24-29 and an anaesthesia cost per minute of €2.25.30 All cost values were inflated to 2019 currency prices and converted to EUR.31,32 Value of savings was derived by multiplying cost per minute(€14.70 + €2.25) by time saved (11.32 minutes for Discectomy and 10.37 minutes for PTS).33

Predicted Cumulative Cost Savings

€368†

Cumulative Cost Saving Opportunities

Control Time (Min)^

UNLEASH Component Time

(Min)

Time Savings (Min)

Potential Cost Savings†

14.96 3.64 11.32 €192

PTS°24 22.22 11.85 10.37 €176

Model Parameters Opportunities UNLEASH Solution* Comparison of current

product offerings† Procedure Savings

Number of Trays° 2 Trays° 6 Trays° 4 Trays°

Procedures per year 50‡

Cost per instrument trayº processed/sterilised

€50.43§

Potential annual reprocessing cost-saving

€10,086ε

6

Time saved from reduced instrument passes can potentially lead to reduced OR costs

Time saved from reduced instrument passes can also potentially lead to reduced sterilization or reprocessing costs:

• Several studies suggest that reductions in instruments/surgical traysº result in reduced sterilization/reprocessingcosts.8,9;34-37

• On average, the UNLEASH Solution is associated with 4 fewer traysº when compared with traditional productofferings, and leads to an estimated annual savings of €10,086 in sterilization costs when assuming 50 proceduresper year at a given institution and a cost of approximately €50 per instrument trayº processed/sterilized.

ECONOMIC Value

* The UNLEASH Solution includes CONCORDE Clear MIS Discectomy Device (0 trays), the PROTI 360° Titanium Integrated Technology (1 tray), and the VIPER PRIME System (1 tray).† Current product offerings include Standard Discectomy Instruments (1 tray), CONCORDE Bullet System (2 trays), and the VIPER® 2 MIS System (3 trays).

° Instrument trays are counted as each individual tray/level within an instrument set.‡ Assumption based on the procedural volume of a mid-sized hospital.§ All cost values were inflated to 2019 currency prices and converted to EUR.31,32

ε Value of savings was derived by multiplying the sterilizing and packaging cost per instrument tray (€50.4310) by the assumption of 50 procedures per year at a given

institution by the number of instrument trays lowered with the UNLEASH Solution (50 procedures x €50.4310 x 4 fewer trays = €10,086).

Discectomy20

(cadaveric)*

^ Control consists of current product offerings of Standard Discectomy Instruments (1 tray), CONCORDE Bullet System (2 trays), and the VIPER®

2 MIS System (3 trays).

REDUCTION* In Primary Packaging

LESS WATER* Used To Sterilize And Disinfect Instruments

REDUCTION*In Materials (Excluding Packaging)

LESS ENERGY* Used To Sterilize And Disinfect Instruments

As Compared To The Existing VIPER 2 System, the VIPER PRIME System Is Associated With51:

7

There is a need to develop more sustainable surgical practices that improve environmental performance

The UNLEASH Solution includes VIPER PRIME System, an Earthwards®

recognized product

• The need for improving environmental effects of healthcare has beenincreasingly discussed in the published literature.38-44

• Hospitals are significant contributors to natural resource depletionand environmental impact.40,44 For instance, steam sterilization in hospitalsis an energy and water intensive process.39

• With the recent push towards sustainability, the operating room has beenidentified as a target for environmentally conscious interventions.45,46

• An important part of the environmental footprint of hospitals relates to useof medical devices.40,47

• Several recent studies have reported on opportunities for improvementin sustainability measures, including more efficient hospital sterilization,and reduced unnecessary instrumentation.38,48,49

• The Earthwards approach is Johnson & Johnson’s continuous improvementprocess that is used to support the development of more environmentallysustainable products.

EARTHWARDS® Recognition°

° Earthwards® is the Johnson & Johnson approach for developing innovative and more sustainable products.* Reduction are in comparison to the existing VIPER 2 system.

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2. Millennium Research Group (2013). RPEU20SP13, 1-525.Millennium Research Group I: Toronto.

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6. Niesche M, Juratli TA, Sitoci K-H, Neidel J, Daubner D, Schackert G, Leimert M. (2014). Clin Neurol Neurosurg 124 (2014): 25-31.

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14. DepuySynthes data on file.TR-201801 Rev A-01. ProTiTM Characterization of Surface Features and Osteoblast Response.

15. DepuySynthes data on file. TR-201803 Rev A-01. Mechanical Testing Report - Tyber Medical Titanium Plasma Spray.

16. Lincks, J. et al. Response of MG63 osteoblast-like cells to titanium and titanium alloy is dependent on surface roughness and composition. Biomaterials 19, 1998. Pages 2219–32

17. Kurtz, S. M. & Devine, J. N., PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007 Volume 28 Pages 4845–69

18. Rho, J. Y., Ashman, R. B. & Turner, C. H. ,Young’s modulus of trabecular and cortical bone material: Ultrasonic and microtensile measurements. J., Biomech. 1993. Volume 26. Pages 111–119

22.

Lee CK, Park JY, Zhang HY (2010). J Korean Neurosurg Soc 48 (3): 219-224.

23.

Phan K, Kim JS, Kim JH, Somani S, Di’Capua J et al. (2017). Global Spine J 7 (8): 727-734.

Grossi P, Badin M, Erb M, Cirilli L, Malone D, Walsh M, Bhattacharyya S (2019) Reduction in pedicle screw placement time with a novel guidewireless pedicle screw system for minimally invasive spine surgery: intial findings.24th Annual International Meeting, ISPOR 2019.

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35. Abrams J, Dekutoski M, Chutkan N Maximizing Operating Room Efficiencyin Spine Surgery. (#477) International Society for the Advancement of Spine Surgery. Boca Raton, Florida. April 13, 2017.

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28. Volpin A, Khan O, Haddad FS (2016). J Arthroplasty 31 (1): 22-26.

29. ISD Scotland (2017). R142X: Theatre - Direct Cost Per Hour, By Specialty. Available online at: http://www.isdscotland.org/health-topics/finance/costs/detailed-tables/theatres.asp.Accessed: July 22, 2019.

41. Buffoli M, Gola M, Rostagno M, Capolongo S, Nachiero D (2014). Ann Ig 26 (5): 418-425.

30. Soegaard R, Christensen FB, Christiansen T, Bunger C (2007). Eur Spine J 16 (5): 657-668.

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REFERENCES

19. VIPER PRIME System Internal Data on File. ADAPTIV SEA 103327910. Note: VIPER Prime System eliminates the following stepswhen compared to the VIPER 2 MIS Spine System: Insert Jamshidi needle, insert guidewire, remove jamshidi needle, insert tap,remove tap, start screw, and remove guidewire.

20. Mo F, Yuan P, Araghi A, Serhan H (2018) Time savings and related economic benefits of suction-curette device for transforaminal lumbar interody fusion discectomy. International Journal of Spine Surgery. 12(5):582-586.

36. Hsu AR, Gross CE, Bhatia S, Levine BR (2012). Orthopedics 35 (11): e1596-1600

37. Morris LF, Romero Arenas MA, Cerny J, Berger JS, Borror CM et al. (2014). Surgery 156 (6): 1441-1449; discussion 1449.

38. McGain F, Moore G, Black J (2017). Aust Health Rev 41 (1): 26-32.

39. McGain F, Moore G, Black J (2016). J Health Serv Res Policy 21 (3): 166-171.

40. McGain F, Naylor C (2014). J Health Serv Res Policy 19 (4): 245-252.

42. Fitzpatrick J (2010). Nurs Times 106 (9): 18-20.

43. Ferenc J (2012). Health Facil Manage 25 (12): 29-32.

44. Balbus J, Berry P, Brettle M, Jagnarine-Azan S, Soares A et al. (2016). Rev Panam Salud Publica 40 (3): 174-180.

31. Fxtop (Web Page) Inflation Calculator. Available online at: http://fxtop.com/en/inflation-calculator.php. Accessed: July 22, 2019.

Fxtop (Web Page) Currency Converter. Available online at: http://fxtop.com/en/currency-converter.php. Accessed: July 22, 2018.

32.

DePuy Synthes (2019). OR Time Cost Savings Calculations (Excel). Data on file.

33.

34. John-Baptiste A, Sowerby LJ, Chin CJ, Martin J, Rotenberg BW (2016). CMAJ Open 4 (3): E404-E408.

8

50 VIPER PRIME System Internal Earthwards® Data on File. ADAPTIV SEA 103339245.

51. VIPER PRIME System Internal Earthwards® Data on File. ADAPTIV SEA 103339245.

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