Integrating New Expandable Technologies into a Minimally-Invasive Spine Practice
Vertebral Compression Fractures: The Case for Using Expandable Implants
Kornelis Poelstra MD PhD The 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.
2 Prevalence of osteoporotic fractures
Burge R et al. (2007) JBMR 22(3): 465 United States Cancer Statistics 2005, American Heart Association
3 Objectives of implant based VCF treatment system
• 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
4 Limitations of existing VCF treatments 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
5 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
1. KAST Study. Per protocol population. Tutton, Garfin, et al. Spine, March 2015 2. Cedars Research Associates. 2014. In Press Pain Physician. 3. Please see Appendix
6 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)
7 Why Implants for VCF
• 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 Sources 1. Otten, Pflugmacher, et al., Pain Physician Journal, October 2013. 2. Korovessis et al. Spine, February 2013 3. Tutton, Garfin, et al. Spine, March 2015
8 Kiva Difference
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
9 KIVA Animation
10 Clinical data
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
11 Kiva for L1 fracture in patient with 6 prior vertebral body compression fractures
• 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 12 Case Discussion
• 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
13 Case Discussion
• 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
14 Case Discussion
• 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 stability Much improved global alignment and local pain control
15 16 Additional Information….
17 Robust Clinical Data
18 Clinical Images of Implant vs. Vertebroplasty
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… 19 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.
2014 4) 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.
21 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 Biomech 2012;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.
22 Thank you for your attention!
23 Integrating New Expandable Technologies into a Minimally-Invasive Spine Practice
3-Dimensional Interbody Expandable for TLIF Procedures
Michael Y. Wang, MD UMH Medical Director, Minimally Invasive Spine UMH, UMH Chief of Neurosurgery
ML10116.B Disclosures Consultant: 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 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.
3 TLIF APPROACH
Fusions by Approach • Various approaches to lumbar interbody ALIF, fusion 19% • TLIF – Extensively studied in literature – Consistent positive outcomes TLIF – Remains surgery of choice (38% of total 38% lumbar fusion procedures in US) • TLIF Shortcomings – Nerve root retraction – Narrow surgical corridor = interbody device size constraints – Lumbar lordosis, disc collapse and LLIF, spondylolisthesis make interbody insertion 29% PLIF, challenging 13% – Cage placement can require aggressive ALIF LLIF PLIF TLIF impaction / bone removal
3 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
3 REMAINING UNMET NEEDS
• Nerve retraction • Implant footprint − Subsidence concerns − Growing emphasis on restoration of lordosis and sagittal alignment Implant width constraint − Places greater biomechanical demands on implant − Footprint critical factor • Need for implant not limited in • Need for large-footprint width by neural structures TLIF interbody
3 3 Animation
3 LUNA 3D EXPANDABLE INTERBODY
• Expansion mechanism accommodates graft insertion post-expansion
• Implant designed for both open and MIS TLIF procedures
3 LUNA | ADVANTAGES
6-8 mm Cannula Delivery • Controlled, atraumatic insertion • Designed to minimize nerve retraction and implant migration
3 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
3 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
3 LUNA | INSERTION & DEPLOYMENT
• Top and bottom implant segments • Third, middle segment follows the deployed from cannula in stacked first two out the cannula configuration • Delivered between them to • Guide wires used to direct linear PEEK achieve distraction segments into curved deployment path • Expands vertically in-situ • Creates circular footprint approximately 25mm in diameter
3 LUNA | INSERTION & DEPLOYMENT
• Luna can restore disc height up to 13mm • 5.0mm window in assembled from 6-8mm cannula implant allows bone graft to be delivered directly into the lumen
• Graft delivered post expansion with accompanying bone graft inserter
Zone 2, Zone 3: Zone 1: Initiate Focus area for Channel successful (standard deployment discectomy (specialized instrumentation) curved, bayonetted tools)
3 Discectomy & Endplate Preparation Zone-Specific Approach Degree of difficulty using Standard Tools
Zone 2: More Challenging Zone 1: Relatively Straightforward Zone 3: Difficult
3
*Pay special attention to Zone 3 for proper Trial and Implant deployment CASE EXAMPLE
• 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 Pre-Op L4-L5 MRIs tubular retractor • Implantation of 10mm expanded LUNA 360 with autograft Case Courtesy of Joshua Ammerman, MD
3 CASE EXAMPLE Pre-Op Images
Case Courtesy of Joshua Ammerman, MD
3 CASE EXAMPLE Post-Op Images
Case Courtesy of Joshua Ammerman, MD
3 Six Week Post-Op L5-S1 Bone Growth Within Device
Case Courtesy of Joshua Ammerman, MD
3 Six Week Post-Op L5-S1 Bone Growth Within Device
Case Courtesy of Joshua Ammerman, MD
3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 34