Integrating New Expandable Technologies into a

Minimally-Invasive Spine Practice

Vertebral Compression Fractures:The Case for Using Expandable Implants

Kornelis Poelstra MD PhDThe Spine Institute on the Emerald Coast

ML10115.B

FDA Labeling

The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit.

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Prevalence of osteoporotic fractures

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Burge R et al. (2007) JBMR 22(3): 465United States Cancer Statistics 2005, American Heart Association

Objectives of implant based VCF treatment system

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• Better and more predictable outcomes• Clinical• Financial• Operational

• Better for everyone involved:• Patients• Treating physicians• The hospital (-system)

• Broad indication• Pathologic Fractures (Osteoporosis, Cancer) and

Trauma

Limitations of existing VCF treatments

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Limitations of existing VCF treatments

• Subsequent/adjacent-level fractures

• Limited or no fracture reduction

• No durable change in kyphotic angle

• Cement extravasation and resulting clinical sequelae

Objectives of implant based VCF treatment

• Provide permanent kyphotic angle reduction

• Use less bone cement

• Reduce subsequent/adjacent-level fracture rate

• Provide treatment through a single-pedicle approach

Overview of Implant VCF Treatment System

• Implant reduced economic burden of traditional VCF treatments1,2

• Multiple Level 1, randomized clinical trials completed3

• 12 peer reviewed papers published in last 4 years3

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1. KAST Study. Per protocol population. Tutton, Garfin, et al. Spine, March 20152. Cedars Research Associates. 2014. In Press Pain Physician.3. Please see Appendix

Overview of Implant VCF Treatment System

• Significant benefits in pain relief, function, height restoration, reduction in volume of cement and reduction in cement extravasation

• Broadest labeling for any compression fracture treatment system on the market

• Implant (Benvenue Medical, Kiva VCF Treatment System) added to Novation agreement through “innovation” award (April ‘15)

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Why Implants for VCF

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• Better pain relief1

• Cement volume reduced2, 3

• Less cement extravasation2

• Cobb angle correction2

• Reduction in subsequent fractures3

• Reduction in procedure time2

• No serious adverse events1,2,3

• Reduction in part numbers to stock; only 2 catalog numbers for all cases

Sources1. Otten, Pflugmacher, et al., Pain Physician Journal, October 2013.2. Korovessis et al. Spine, February 20133. Tutton, Garfin, et al. Spine, March 2015

Kiva Difference

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Features

• Expands to 15mm in height

• Flexible PEEK-Optima® Structure

• Flat, circular 20mm diameter

Benefits

• Designed to restore and maintain sagittal alignment

• Provide more compliant construct than cement alone

• Predictable endplate support

KIVA Animation

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Clinical data

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Over the past 20 years there have been 1,587 papers written on the treatment of vertebral compression fractures

8 articles met criteria (Level I or II studies) based on 1°Research as adopted by NASS (see link below)

2 of the 8 papers are related to the Benvenue Medical Kiva VCF Treatment System.

- KAST (see appendix, paper #2)- Korovessis (see appendix, paper #5)

Level 1 data: High quality randomized trial with statistically significant difference or no statistically significant difference but narrow confidence intervals. Systematic Review of Level I RCTs and study results were homogenous.https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/LevelsOfEvidence.pdf

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• Excellent height restoration from a combination of positional reduction, 5 coils of Kiva deployed

• Patient immediately regained a sensation of stability, pain control was absolutely immediate and she left the hospital same day.

https://www.docmatter.com/dm/site/discuss/viewEntry.jsp?msid=11613

Kiva for L1 fracture in patient with 6 prior vertebral body compression fractures

Case Discussion

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• 85 y/o female vertigo: fall• Attempted bracing / narcotics• Failed over 3 weeks• Upright Radiographs showed:

• Vertebra “plana” T12• Global kyphosis increase• Stiff spine leads to:

“three-column fracture”with perceived instability

Case Discussion

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• CT-scan clearly shows ‘vacuum’ phenomenon at the Fx.• Fracture “opens up” when patient supine in the scanner• Concerns for global instability and not just anterior compression

Case Discussion

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• Instead of “Stand-Alone” Kiva…• Screw and rod construct with

internal support of T12 with Kiva deployment.

Overnight stay in hospital for observation (85 y/o)Up-and-walking with immediate sense of stabilityMuch improved global alignment and local pain control

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Additional Information….

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Robust Clinical Data

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Clinical Images of Implant vs. Vertebroplasty

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Significant cement extravasation

Significant cement volume (~10 cc)

Adjacent level fracture potentially caused by volume of cement

Benvenue Medical Kiva VCF Treatment System• Cement contained with implant• Reduced volume of cement (~ 2 cc)• Kyphotic height restoration

We all recognize these pictures more than we like to admit…

Peer reviewed papers

2016 (expected publication date)

1) (Garfin S, Beall DP, Tutton S, Hornberger J). Incidence and Cost of Serious Adverse Events Requiring Hospital

Readmission with Kiva VCF Treatment System Compared to Balloon Kyphoplasty: KAST Randomized Trial Analysis. IN

PROGRESS FOR SUBMISSION TO JAMA OR SPINE—publish 2016

2015

2) Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR. KAST study: The Kiva system as a vertebral

augmentation treatment—a safety and effectiveness trial. Spine 2015;40(12):865-875.

3) Beall DP, Olan WJ, Kakad P, L Q, Hornberger J. Economic analysis of Kiva VCF treatment system compared to balloon

kyphoplasty using randomized Kiva safety and effectiveness trial (KAST) data. Pain Physician 2015;18:E299-E306.

20144) Berjano P, Damilano M, Pejrona M, Consonni O, Langella F, Lamartina C. Kiva VCF system in the treatment of T12

osteoporotic vertebral compression fracture. Eur Spine J 2014;23(6):1379-80. “How To” case report: 73 year-old

woman with previously treated VCF

5) Korovessis P, Vardakastanis K, Vitsas V, Syrimpeis V. Is Kiva implant advantageous to balloon kyphoplasty in treating

osteolytic metastasis to the spine? Comparison of 2 percutaneous minimal invasive spine techniques. Spine

2014;39(4):E231-E239.

6) Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus Kiva vertebral augmentation –

comparison of 2 techniques for osteoporotic vertebral body fractures. Spine 2013;38(4):292-299.

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Peer reviewed papers (cont’d)

7) Otten LA, Bornemann R, Jansen TR, Kabir K, Pennekamp PH, Wirtz DC, Stuwe B, Pflugmacher R. Comparison of

balloon kyphoplasty with the new Kiva VCF system for the treatment of vertebral compression fractures. Pain

Physician 2013;16:E505-E512.

8) Anselmetti GC, Manca A, Tutton S, Chiara G, Kelekis A, Facchini FR, Russon F, Regge D, Montemurro F.

Percutaneous vertebral augmentation assisted by PEEK implant in painful osteolytic vertebral metastasis involving

the vertebral wall: Experience on 40 patients. Pain Physician 2013;16:E397-E404.

9) Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Transpedicular vertebral body augmentation reinforced with

pedicle screw fixation in fresh traumatic A2 and A3 lumbar fractures: Comparison between two devices and two

bone cements. Eur J Orthop Surg Traumatol 2013 (28 Aug):DOI 10.1007/s00590-013-1296-9.

2012

10) Wilson DC, Connolly RJ, Zju Q, Emery JL, Kingwell ST, Kitchel S, Cripton PA, Wilson DR. An ex vivo biomechanical comparison of a novel vertebral compression fracture treatment system to kyphoplasty. Clin Biomech2012;27:346-353.

11) Anselmetti GC, Tutton SM, Facchini FR, Miller LE, Block JE. Percutaneous vertebral augmentation for painful osteolytic vertebral metastasis: a case report. Int Med Case Rep J 2012;5:13-17.

12) Bornemann R, Otten LA, Koch EM, Jansen TR, Kabir K, Wirtz DC, Pflugmacher R. Kiva VCF treatment system –clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures. Z Orthop Unfall 2012;150(6):572-578.

2011

13) Korovessis P, Repantis T, Miller LE, Block JE. Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: A case series of 26 consecutive patients. BMC Musculoskeletal Disorders 2011;12:206.

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Thank you for your attention!

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3-Dimensional Interbody

Expandable for TLIF Procedures

Integrating New Expandable

Technologies into a

Minimally-Invasive Spine Practice

Michael Y. Wang, MD

UMH Medical Director, Minimally Invasive Spine

UMH, UMH Chief of Neurosurgery

ML10116.B

DisclosuresConsultant: Depuy Spine

Aesculap Spine

JoiMax

K2M

Royalties: Children’s Hospital of Los Angeles

Depuy Spine

Springer Publishing

Quality Medical Publishing

Stock: Innovative Surgical Devices

Spinicity

Grants: Department of Defense

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FDA Labeling

INDICATIONS

The Luna 360 Interbody Fusion System consists of a Luna 360 Implant and associated

accessories. This system is indicated for spinal fusion procedures in skeletally mature

patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels

from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed

by patient history and radiographic studies. These DDD patients may also have up to grade

I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion

System is to be used with autogenous bone graft. Patients receiving the device should have

had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant.

The Luna 360 Interbody Fusion System is to be used with supplemental fixation.

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TLIF APPROACH

• Various approaches to lumbar interbody

fusion

• TLIF

– Extensively studied in literature

– Consistent positive outcomes

– Remains surgery of choice (38% of total

lumbar fusion procedures in US)

• TLIF Shortcomings

– Nerve root retraction

– Narrow surgical corridor = interbody device

size constraints

– Lumbar lordosis, disc collapse and

spondylolisthesis make interbody insertion

challenging

– Cage placement can require aggressive

impaction / bone removal

ALIF, 19%

LLIF, 29%

PLIF, 13%

Fusions by Approach

ALIF LLIF PLIF TLIF

TLIF

38%

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EXPANDABLE INTERBODY DEVICES

• Recent proliferation of expandable

interbodies

• Wide variation in material and

expansion mechanisms

• All designed to be inserted in

collapsed configuration and

expanded vertically in-situ

• Solve issues around cephalad-caudal

constraints

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REMAINING UNMET NEEDS

• Need for implant not limited in

width by neural structures

Implant width

constraint

• Implant footprint

− Subsidence concerns

− Growing emphasis on

restoration of lordosis

and sagittal alignment

− Places greater

biomechanical

demands on

implant

− Footprint critical

factor

• Need for large-footprint

TLIF interbody

• Nerve retraction

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Animation

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LUNA 3D EXPANDABLE INTERBODY

• Expansion mechanism

accommodates graft insertion

post-expansion

• Implant designed for both

open and MIS TLIF

procedures

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LUNA | ADVANTAGES

6-8 mm Cannula Delivery

• Controlled, atraumatic

insertion

• Designed to minimize

nerve retraction and

implant migration

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LUNA | ADVANTAGES

In-situ 3D Expansion

• Zero-impaction delivery

• Intended to preserve and

protect vertebral

endplates

• Expands 25 mm in

diameter, 8-13 mm in

height

• Designed to provide

stable implant for spine

alignment goals

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LUNA | ADVANTAGES

Post-Expansion Bone

Grafting

• Designed to place bone in

direct contact with

vertebral endplates

• Generous area for graft

containment

• Large window for graft

insertion

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LUNA | INSERTION & DEPLOYMENT

• Top and bottom implant segments

deployed from cannula in stacked

configuration

• Guide wires used to direct linear PEEK

segments into curved deployment path

• Creates circular footprint approximately

25mm in diameter

• Third, middle segment follows the

first two out the cannula

• Delivered between them to

achieve distraction

• Expands vertically in-situ

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LUNA | INSERTION & DEPLOYMENT

• Luna can restore disc height up to 13mm

from 6-8mm cannula

• 5.0mm window in assembled

implant allows bone graft to be

delivered directly into the lumen

• Graft delivered post expansion

with accompanying bone graft

inserter

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Discectomy

Zone 1: Initiate

Channel

(standard

discectomy

instrumentation)

Zone 2, Zone 3:

Focus area for

successful

deployment

(specialized

curved,

bayonetted tools)

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Discectomy & Endplate Preparation

Zone-Specific Approach

Zone 1: Relatively

Straightforward

Zone 2: More

Challenging

Zone 3:

Difficult

Degree of difficulty using Standard Tools

*Pay special attention to Zone 3 for proper Trial and Implant deployment

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CASE EXAMPLE

Case Courtesy of Joshua Ammerman, MD

• 67 yo female

• 6 months of R>L neurogenic claudication

• Failed 6 weeks of PT and epidural injections

• MRI/XRAYs

• Large R L4-L5 facet cyst with lateral

recess and foraminal compression

• Advanced facet arthropathy bilateral

• 3-4mm subluxation of L4 on L5 with

standing XRAYs

• Treatment

• Right L4-L5 MIS TLIF thru a 22mm fixed

tubular retractor

• Implantation of 10mm expanded LUNA

360 with autograft

Pre-Op L4-L5 MRIs

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CASE EXAMPLE

Pre-Op Images

Case Courtesy of Joshua Ammerman, MD

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CASE EXAMPLE

Post-Op Images

Case Courtesy of Joshua Ammerman, MD

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Six Week Post-Op

L5-S1 Bone Growth Within Device

Case Courtesy of Joshua Ammerman, MD

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Six Week Post-Op

L5-S1 Bone Growth Within Device

Case Courtesy of Joshua Ammerman, MD

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