Merit Medical Systems, Inc. · NASDAQ:MMSI
Merit Medical Systems — Technical Presentation (May 2018)
25 slides from Merit Medical Systems's technical presentation, May 2018
Slide 1: Minimally Invasive Radiofrequency Ablation Treatment of Metastatic Spinal Tumors
Minimally Invasive Radiofrequency Ablation Treatment of Metastatic Spinal Tumors 1
Slide 2: Objectives
Objectives • Demographics of spinal tumors • Treatment options and goals • Adoption of RF ablation for pain palliation by NCCN • Clinical Evidence 2
Slide 3: Overview of spine metastases
Overview of spine metastases • 10 million Americans with cancer with 1.7 million dx/year 1 • 10% will develop symptomatic spine mets 2 • Spinal SREs – pain requiring palliative radiation therapy (RT) or surgical intervention – pathologic vertebral compression fracture (VCF) – metastatic epidural spi
Slide 4: Bone Metastases: Large, Underserved Patient Group
Bone Metastases: Large, Underserved Patient Group Metastatic Bone Disease Is Prevalent in Many Types of Cancer FIVE-YEAR WORLD INCIDENCE OF BONE MEDIAN SURVIVAL CANCER PREVALENCE1 METASTASES IN CANCERS2 (MONTHS)2,3 Myeloma 144,000 70%-95% 6-54 Renal 480,000 20%-25% 6 Melanoma 533,000 14%-45% 6 Thyro
Slide 5: Nature of Spinal Metastases
Nature of Spinal Metastases Metastatic Spinal Metastases commonly osteolytic, affect multiple vertebrae and involve posterior vertebral body 1,2 • 600 cases of spinal metastases examined according to clinical characteristics, type of primary tumor, site of lesion, and survival • 94/95 (99%) involved
Slide 6: Three primary pain generators in the spine
Three primary pain generators in the spine • Mechanical Pain • Biological Pain • Radicular/myelopathic – Instability from – Stretching/irritation of the – Canal or neuroforamenal pathologic micro- periosteum: secondary to involvement of tumor fractures tumor growth – Severe compression fracture – Os
Slide 7: Treatment Goal... Rapid & Lasting Pain Relief
Treatment Goal... Rapid & Lasting Pain Relief • Debulk and Decompress tumor • Stabilize • Minimize active bone destruction • Destroy nerve endings • Decrease neuro-stimulating Cytokines • Local Control Wallace et al. Oncologist 2015 v20 p1205-15 7
Slide 8: Focal Palliative Treatment of Bone Metastases
Focal Palliative Treatment of Bone Metastases • Radiation Therapy – EBRT: • Standard of Care for bone met palliation - single versus multiple fraction regimen • Rate and degree of pain relief is weeks to months • Partial and complete palliation rates of 60% and 23%, respectively (Chow et al, Clin On
Slide 9: Patient Selection Treatment Options
Patient Selection Treatment Options • Symptoms Spine Instability Neoplastic Score (SINS) • Surgery – Intensity – Decompression – Acuity – Stabilization – Quality: Mechanical/ Neuropathic – Corpectomy/GTR • Patient • Radiation – Life expectancy – EBRT – Performance status (KPS, ECOG) – SRS/SBRT – Med
Slide 10: NCCN Principles of Cancer Pain Management
NCCN Principles of Cancer Pain Management 1 Targeted tumor ablation supports NCCN Principles 2,3 There is increasing evidence in oncology that survival is linked to symptom reporting and control and that pain t-RFA provides clinically significant pain relief to patients management contributes to bro
Slide 11: Treating Metastatic Vertebral Body Tumors through a minimally invasive RFA procedure
Treating Metastatic Vertebral Body Tumors through a minimally invasive RFA procedure Access & Navigation: Active steering capability reaches desired target location within the tumor via a unipedicular approach Controlled Energy Delivery: RF energy is delivered as the instrument actively monitors
Slide 12: Targeted Radiofrequency Ablation
Targeted Radiofrequency Ablation Navigational Bipolar Radiofrequency Ablation Device SpineSTAR Ablation Instrument MetaSTAR RF Generator • Articulating electrode to optimize location • Active temperature measurements • Multiple thermocouples to confirm/quantify zone • Displays critical real-time inf
Slide 13: Controlled thermal distribution - predictable ablation zone
Controlled thermal distribution - predictable ablation zone • Multiple thermocouples embedded along length of electrode • Confirm and Quantify Ablation Zone intra-operatively • Real time assessment of thermal spread of ablation zone • Temperature monitored on Generator display • 3:2 length to width
Slide 14: Clinical Data
CLINICAL DATA Is targeted RF ablation of spinal tumors effective in relief of pain? 14
Slide 15: Multicenter Retrospective Study of Navigational Bipolar RFA Device
Treatment of Spine Metastatic Lesions with a Navigational Bipolar Radiofrequency Ablation Device: Multicenter Retrospective • 128 lesions ablated in 92 patients using STAR System • 5 academic medical center multicenter study • Immediate, significant and durable pain relief • No reported complication
Slide 16: Treatment of Metastatic Posterior Vertebral Body Osseous Tumors by Targeted Bipolar RFA
Treatment of Metastatic Posterior Vertebral Body Osseous Tumors by Using a Targeted Bipolar RFA Device • 47 posterior VB tumors treated in 26 patients using the STAR System • 9 patients (35%) had prior RT at same tumor • Primary cancer types: – breast, lung, prostate, renal cell carcinoma • Pain dec
Slide 17: Multicenter prospective series of RFA in painful spine metastatic lesions
Multicenter prospective series of RFA in painful spine metastatic lesions • 69 lesions in 50 patients - Treated with STAR Tumor Ablation System NCCN Guidelines Version 2.2016: Adult • Rapid onset, significant, durable pain reduction Cancer Pain Increasing evidence in oncology that • Decreased Disabi
Slide 18: Palliative Radiation Therapy: Opportunities to improve the gold standard
Palliative Radiation Therapy: Opportunities to improve the gold standard • Meta-analysis of 11 individual prospective trials comparing effectiveness of palliative single and multi-fraction RT • 3,435 patients treating 3,487 painful sites • Most common primary cancers: prostate, breast, and lung Sing
Slide 19: RFA + RT adjuvant: An enabling technology
RFA + RT adjuvant: An enabling technology • Patients with solitary bone metastases and a VAS pain score ≥ 5 • n=15 RFA+RT (20 Gy delivered in 5 fractions of 4 Gy over 1 week) • n=30 treated with RT (matched group) RT only RFA+RT P-value Overall response 60% 93% < .05 Complete pain relief 17% 53% < .
Slide 20: Combined t-RFA and radiation therapy of spinal metastases
Combined t-RFA and radiation therapy of spinal metastases • Retrospective 21 patients 36 spinal metastases (STAR System) - Concurrent ablation (21/22RFA; 1/22 Cryo) + RT within 4 wks - RT: 63% Conventional fractionated, 27% SBRT; 9% unknown - Lung (38%); renal cell (24%); breast (14%); rectal (9%) -
Slide 21: t-RFA in radiation resistant lesion
t-RFA in radiation resistant lesion post t-RFA L2/L3 6 mos post t-RFA of L2-L3 pre t-RFA T11-T12 3 mos post t-RFA of T11-T12 • Metastatic renal cell post EBRT: • 3 months post ablation at T11-12 – L2/L3 vertebral lesions ablated and augmentation – retraction of previously seen epidural – T11/T12 sma
Slide 22: Patients with focalized pain who may benefit from RFA
Clinical experience/evidence suggest patients with focalized pain from metastatic spinal tumor who may benefit from RFA with radio-resistant tumors (e.g. - RCC, melanoma, sarcoma) with persistent and/or recurrent pain after radiation therapy with posteriorly positioned metastatic tumors who
Slide 23: Summary
Summary • Percutaneous spine ablation is becoming more integrated into the multi- disciplinary algorithm for treatment of metastatic spine disease, especially in patients who have failed RT or in which it is not a clinical option • Patient selection is paramount, should be done in a multi-disciplina
Slide 24: STAR Tumor Ablation System
STAR Tumor Ablation System Indications for Use The STAR Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body Risks and Contraindications As with most surgical procedures, there are risks associated with the S
Slide 25: Thank You
Thank You 403996001/001 25
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