Merit Medical Systems, Inc. · NASDAQ:MMSI
Merit Medical Systems — Technical Presentation (June 2018)
40 slides from Merit Medical Systems's technical presentation, June 2018
Slide 1: Clinical Data and Efficacy in the Treatment of Vertebral Compression Fractures
Clinical Data and Efficacy in the Treatment of Vertebral Compression Fractures Author Affiliation 1
Slide 2: Perception vs. Reality
Perception vs. Reality Perception Reality • Patients get better by themselves with • Vertebroplasty does work bed rest • Augmentation does work • Vertebroplasty doesn’t work • Mortality & costs increase when VCF not • Vertebral Augmentation (VA) doesn’t treated work • Fractures remain a large societ
Slide 3: Osteoporosis Epidemiology
Osteoporosis Epidemiology Number of Americans with the diagnosis of osteoporosis. 10 million [T-score <2.5] 80% are women.1 Spine fractures that occur annually. These exceed occurrence of hip and wrist 700,000 fractures combined.2 National and direct expenditures (hospitals and nursing homes) for os
Slide 4: Under Diagnosed and Untreated
Under Diagnosed and Untreated • Two thirds of all vertebral fractures go undiagnosed – History not specific “it hurts everywhere” – Co-morbidities take priority (cardiac, pulmonary) – Low index of suspicion – 42% of symptomatic fractures not collapsed on radiographs • Moderate or severe fractures re
Slide 5: VCF Risk Factors
VCF Risk Factors • Bone mineral density • Age • Sex • Fracture deformity • Prior fracture • Bone affecting drugs – Steroids – 2.6 x risk – Chemotherapy and BMT – Seizure medications Cosman F, Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25(10): 2359–2381 Riggs
Slide 6: VCF Risk: Age & Sex
VCF Risk: Age & Sex • Higher in women than men at any age due to low BMD • Risk increases with age, independent of BMD EPOS Group. J Bone Miner Res. 2002 Apr;17(4):716-24. 6
Slide 7: VCFs Increase Risk of New Fractures
VCFs Increase Risk of New Fractures • Prevalence of vertebral fractures are highly significant predictors of additional fracture incidence 1 • 5-fold increased risk of a new vertebral fracture • 2-fold increased risk of hip fracture 2,3 • 12-fold after 2 or more VCFs3 1. Ross et al. Annals of Intern
Slide 8: Increased Mortality
Increased Mortality Relative Risk of Death in 3.8 yrs 11 9 6.68X 8.64X 7 5 2 1X 0 Age-Matched Control Hip Fracture Spine Fracture Cauley JA, Osteoporosis Int. 2000;11(7) p556-61 8
Slide 9: MEDPAR data support clinical benefit of MI Procedures in VCF Treatment
MEDPAR data support clinical benefit of MI Procedures in VCF Treatment Impact of Nonoperative Treatment, Vertebroplasty and Kyphoplasty on Survival and Morbidity after VCF in Medicare Population1 • 2006 MEDPAR data on 68,752 patients demonstrate improvement in post-discharge survival and morbidity •
Slide 10: Medical Management and bed rest considerations
Medical Management and bed rest considerations • Medical management often involves bed rest1 – as few as 2 days of bed rest lead to bone mass loss2 – by 1 week, the rate of bone loss is 50 times the normal age-related rate3 – after 10 days, 15% of aerobic capacity and lower extremity strength is los
Slide 11: Under-treatment based on misinterpretation of VP/VA evidence in 2009
Under-treatment based on misinterpretation of VP/VA evidence in 2009 • Clinical Evidence Background – Minimally invasive vertebral augmentation topic of much debate – 4 Prospective Randomized Trials published in NEJM and Lancet re: efficacy of MI procedures – NEJM: no statistical significant clinica
Slide 12: Comparison of NEJM and Lancet Studies
Comparison of NEJM and Lancet Studies CON PRO NEJM studies (Kallmes/Buchbinder) Lancet studies (Wardlaw/Klazen) • Multicenter, randomized controlled • Multicenter, randomized controlled Study • Control: sham injection at periosteum • Control: Conservative care • Patients blinded • Time past fracture
Slide 13: Analysis of Reporting Bias in Vertebral Augmentation
Analysis of Reporting Bias in Vertebral Augmentation • Kallmes et al and Buchbinder et al found no beneficial effect of cement augmentation when VP was compared with paraspinal injection of local anesthetic (sham) • Both studies have been downgraded after further review and scrutiny • Since 2009, th
Slide 14: EVOLVE Study: Kyphoplasty Outcomes in Treatment of VCFs
Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in Treatment of VCFs: EVOLVE Study • 350 patients with painful VCFs enrolled and treated with BKP across 24 sites – Etiology: 97% osteoporosis; 2% cancer – Acute or subacute (≤ 4 mos.); pain
Slide 15: Percutaneous Vertebral Augmentation: A Consensus Statement
Percutaneous Vertebral Augmentation: Percutaneous Vertebral Augmentation: A Consensus Statement A Consensus Standards of Statement Practice Vertebral Augmentation Joint Position Statement • Percutaneous Vertebral Augmentation (PVA) remains a proven medically appropriate therapy for treatment of pain
Slide 16: VAPOUR: Vertebroplasty for Acute Painful Osteoporotic Fractures
Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR); a multicenter, randomized, double-blinded, placebo-controlled trial • 120 pts enrolled and treated: 61 Vertebroplasty and 59 Placebo – VCF < 6 wks; pain > 7/10 with concomitant MRI (or SPECT-CT) – 57% patients w
Slide 17: VAPOUR Trial
VAPOUR Trial • Improved scores favorable to VP across all study measurements • Median duration of hospital stay reduced by 5.5 days in VP group • Vertebral body height loss @ 6-months: ─ 27% loss in VP vs. 63% loss in placebo group Clark W, Lancet 2016 Oct 1_388_10052 p1408-1416 17
Slide 18: Referral Messaging Regarding Efficacy of Procedures for VCFs
Referral Messaging Regarding Efficacy of Procedures for VCFs • How to identify patients likely to benefit from procedure? 1 – Patient history – Acuity of fracture – Pain on a pain scale of 1-10 – Physical examination – MRI (best) or bone scan + CT (patient unable to undergo MRI): MRI can show edema
Slide 19: Intervention Criteria / Patient Selection
Intervention Criteria / Patient Selection • Pain unrelieved by narcotics • Decreased mobility • Radiographic evidence of fracture • Pain localized to fracture level • Non-focal neurologic examination 19
Slide 20: Natural History?
Natural History? T12 Vertebral Compression Fracture January 2003 February 2003 Courtesy of Michael Hisey, M.D. Texas Back Institute 16000229-01 Nevitt MC et al. Bone. 1999;25:613–619. Cooper C et al. J Bone Min Res. 1992;7:221–227. March 2003 20
Slide 21: Intervention Criteria Changing Patient Selection
Intervention Criteria Changing Patient Selection • Early intervention • Early ambulation and rehab • Decrease hospitalization period • Prevent further injury (acute on chronic) 21
Slide 22: Diagnosing VCF
Diagnosing VCF • Patient who is >50 years old with sudden onset of back pain • Physical examination – Tenderness over area of possible fracture – Muscle spasm – Pain with movement and standing • Lateral spine radiograph can screen for VCF • MRI confirms diagnosis • Beware of infection and unstable f
Slide 23: VCF Diagnosis and Acuity: MRI
VCF Diagnosis and Acuity • MRI – Determines fracture acuity – Differentiates: discs, metastatic disease T2/STIR (Bright) – Edema – Clefts T1 (dark) – Edema – Fracture lines 23
Slide 24: VCF Diagnosis and Acuity: Bone Scan with SPECT
VCF Diagnosis and Acuity • Bone Scan with SPECT – If MRI is contraindicated; ICD – Increased tracer in areas of high bone activity – Increased uptake in fractured bone for months, depending on degree of remodeling - identifies new and recently healed fractures – 3 phase scan can assist in determinin
Slide 25: VCF Diagnosis and Acuity: CT
VCF Diagnosis and Acuity • CT – Excellent for delineating osseous anatomy – Sagittal images key – Fracture plane generally easy to visualize – Difficult to determine age of fracture • Compare with Prior Imaging 25
Slide 26: Treatment Options
Treatment Options • Conservative Management ─ Pain medications ─ Back brace to provide support and stability ─ Bed rest ─ Physical Therapy • Minimally Invasive Surgery ─ Vertebroplasty ─ Vertebral augmentation Balloon Kyphoplasty Targeted Vertebral Augmentation • Open Surgery ─ Limited to neurol
Slide 27: Minimally Invasive Surgery: Vertebroplasty
Minimally Invasive Surgery Vertebroplasty • Uses local, moderate sedation, or general anesthesia • 11g-13g needle guided into the fractured vertebra • Bone cement injected into the fractured vertebra • Needle removed. Cement hardens in ~10 mins • Limitations: – Thinner cement, may leak before optima
Slide 28: Minimally Invasive Surgery: Balloon Kyphoplasty
Minimally Invasive Surgery Balloon Kyphoplasty • Uses moderate sedation or general anesthesia • Balloon placed into the vertebra and inflated • Balloons create a cavity within the vertebral body • Cement injected after balloons removed to stabilize fracture • Limitations: – Large cement bolus with v
Slide 29: Evolution of Treatment Options
Evolution of Treatment Options Advanced Augmentation Options Balloon Kyphoplasty (BKP) Vertebroplasty (VP) Invasive Spine Surgery or Medical Management 29
Slide 30: Innovation in VCF Treatment: Targeted Vertebral Augmentation
Innovation in VCF Treatment: Targeted Vertebral Augmentation PowerCURVE Navigating Targeted cavity creation spares Targeted pathways maximize Osteotome enables targeted cancellous bone as it creates surface area for cement vertebral access across midline via preferential pathways for interdigitation
Slide 31: Targeted Cavity Creation
©2015 DFINE Inc. All rights reserved. PML5245-AA Targeted Cavity Creation Navigating Osteotome: Introduction of osteotome • creates preferential paths for delivery of bone cement into vertebral body and initial • allows for bone sparing targeted cavity creation articulation • unipedicular approach A
Slide 32: Why Targeted Vertebral Augmentation (TVA)
Why Targeted Vertebral Augmentation (TVA) • Creates targeted cavities to improve cement flow and distribution (Navigational Osteotome/Steerable Balloon) • High viscosity cement Interdigitation • Consistent high viscosity cement over extended period of time Less leakage • Option to control cement
Slide 33: Navigational Technology to permit targeted therapy
Navigational Technology to permit targeted therapy Navigational Targeted Cavity Creation PowerCurve Osteotome Steerable Balloon 33
Slide 34: Continuing Conservative Care vs Crossover to TVA
Continuing Conservative Care vs Crossover to TVA: Comparative Effectiveness Significantly reduced pain and disability • 65 patients were treated with conservative care • 33 patients chose to cross over to TVA after conservative care • Conclusions ─ Vast majority of patients with VAS ≥ 5, conservativ
Slide 35: Comparison of Clinical & Radiological Data: TVA or BKP
Comparison of Clinical & Radiological Data in Treatment of Osteoporotic VCFs: TVA or BKP Reduced pain, procedure time and risk of cement extravasation VAS VAS Procedure Cement Improvement Improvement (Minutes) Extravasation Post Op 6 months (p>0.001) (p> 0.0001) (p> 0.02 ) (p> 0.001) Targeted Verteb
Slide 36: Treatment of VCFs due to Multiple Myeloma
Treatment of VCFs due to Multiple Myeloma • 66 TVA procedures performed • 10-point visual analog scale (VAS) to assess pre/post-op back pain • Pain medication changes recorded ─ Significant decrease in pain, and increase in activity ─ Significant decrease in narcotic use observed at 6 months Number
Slide 37: TVA Case
TVA Case L2 • 72 year old woman • Referred for L2 fracture • MRI: – Old L2 fx – L3 Edema and fx Courtesy of D. Enterline, M.D. Duke University 37
Slide 38: Navigational Osteotome bone sparing targeted cavity creation
Navigational Osteotome bone sparing targeted cavity creation Initial Cement Delivery Controlled Delivery of High Viscosity Cement Additional preferential cavity creation Cement filling compromised areas of bone Optimal cement fill Courtesy of D. Enterline, M.D. Duke University 38
Slide 39: StabiliT Vertebral Augmentation Systems
StabiliT® Vertebral Augmentation Systems • Indications for Use – StabiliT® Vertebral Augmentation Systems are intended for percutaneous delivery of StabiliT® Bone Cement. The StabiliT bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyph
Slide 40: Thank You
Thank You 403997001/001 40
Merit Medical Systems — Technical Presentation (June 2018) on 6ix