Adagio Medical Holdings, Inc · NASDAQ:ADGM
Adagio Medical — SPAC Merger (February 2024)
77 slides from Adagio Medical's SPAC merger presentation, Feb 14, 2024
Slide 1: Adagio Medical Investor Presentation
ADAGIO MEDICAL Investor Presentation | February 2024
Slide 2: Disclaimer
DISCLAIMER 2 This investor presentation (together with the oral statements made in connection herewith, this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination and any related transaction, i
Slide 3: Disclaimer (cont.)
DISCLAIMER (CONT.) 3 Combination; (6) delays in obtaining, adverse conditions in, or the inability to obtain regulatory approvals, or delays in completing regulatory reviews, required to complete the Business Combination; (7) the ability to meet stock exchange listing standards prior to or following
Slide 4: Disclaimer (cont.) Participants in the Solicitation
DISCLAIMER (CONT.) 4 Participants in the Solicitation ARYA, the Company, ListCo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from ARYA’s shareholders with respect to the Business Combination. A list of the names of ARYA’s direc
Slide 5: Why Invest: Adagio Medical Opportunity in a Nutshell
WHY INVEST: ADAGIO MEDICAL OPPORTUNITY IN A NUTSHELL 5 Highly differentiated technology with focus on improved ablation outcomes Comprehensive portfolio of solutions for atrial and ventricular arrhythmias Extensive pipeline of clinical investigations Investor Validation Near-term value drivers Q4 20
Slide 6: Today's Presenters
TODAY’S PRESENTERS 6 Olav Bergheim CEO & President John Dahldorf Chief Financial Officer 20+ years of corporate finance experience 30+ years of experience in life sciences Founder of Innovative cardiac ablation medical technology company ✔ Focused on large, underserved market – cardiac arrythmia add
Slide 7: Invasive Treatments of Cardiac Arrhythmias
INVASIVE TREATMENTS OF CARDIAC ARRHYTHMIAS Using surgical cuts or catheter-created lesions to cut and isolate aberrant electrical circuits in the heart 7 Normal Electrical Conduction Ventricular Tachycardia (VT) VT is a heart rhythm problem (arrhythmia) caused by irregular electrical signals in the
Slide 8: EP Market: Continuing Growth, Perennial Opportunity
EP MARKET: CONTINUING GROWTH, PERENNIAL OPPORTUNITY 9% CAGR Worldwide EP Market (Main Competitors)1 Worldwide $7.3bn EP Market Breakdown3 $5.1B $7.3B2 EP Ablation Catheters (consumables) ~$3.2B ~4% of total J&J revenue ~3% of total Medtronic revenue ~4% of total Abbott Laboratories revenue ~5% of to
Slide 9: Initial Focus on Highest Needs and Upsides
INITIAL FOCUS ON HIGHEST NEEDS AND UPSIDES 9 PAROXYSMAL AF (PAF) SVT/AFL PERSISTENT AF (PsAF) V-TACH (VT) 1%-4% CAGR 10%-13% CAGR 5%-8% CAGR $0.8B $0.8B $1.2B $0.3B SIMPLE CATHETERS ADVANCED CATHETERS ~75% of the market is in the “advanced” catheters: irrigated Radiofrequency (RF) ablation with cont
Slide 10: Atrial Fibrillation Market: Opportunity, Drivers and Inhibitors
ATRIAL FIBRILLATION MARKET: OPPORTUNITY, DRIVERS AND INHIBITORS
Slide 11: AF Market: Full Upside Requires Improvement in Long-Term Outcomes
AF MARKET: FULL UPSIDE REQUIRES IMPROVEMENT IN LONG-TERM OUTCOMES Cases (millions) 0.23 1.9 8.6 4% CAGR 4% CAGR 14% CAGR 11 6-8x upside in ablations if Class I indication as 1st line therapy – not achievable at current rates of recurrence, re-ablations and associated morbidity US AF Disease1 and Tre
Slide 12: PFA: New Technology, Same Efficacy (So Far)
PFA: NEW TECHNOLOGY, SAME EFFICACY (SO FAR) 12 FARAPULSE/BSX: MANIFEST-PF REGISTRY1 MDT: PULSED AF TRIAL2 Turagam MK, Neuzil P, Schmidt B, et al. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. 2023;148:35–
Slide 13: AFib Catheter Ablation Outcomes: In Need of Technology Breakthrough
AFIB CATHETER ABLATION OUTCOMES: IN NEED OF TECHNOLOGY BREAKTHROUGH 13 Category Therapy Option Representative Players 1st year single procedure freedom from AF Mortality Serious Adverse Events* Drugs AADs1 3M, Arbor 27% Baseline N/A Catheter RF point-by-point1 JnJ, ABT, BSX, MDT 69% +0% 5.5% Cathete
Slide 14: Ventricular Tachycardia Ablations Market: Opportunity, Drivers and Inhibitors
VENTRICULAR TACHYCARDIA ABLATIONS MARKET: OPPORTUNITY, DRIVERS AND INHIBITORS
Slide 15: VT Market: Current Risk-Benefit Caps Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT CAPS ABLATION THERAPY PENETRATION 2% CAGR 7% CAGR 2-3x7 market growth opportunity with improved ablation effectiveness and reduced risk profile within EP practice ~ 3.5M Reduction of symptomatic arrhythmic events (VT storms), ICD therapies, and removal vs escalation o
Slide 16: Initial Focus on Segments of Highest Need
INITIAL FOCUS ON SEGMENTS OF HIGHEST NEED VT + Persistent AF markets: ~$1B / ~10% CAGR – attractive segment for share taking and market expansion PAROXYSMAL AF (PAF) SVT/AFL PERSISTENT AF (PsAF) V-TACH (VT) Highly effective and safe Low clinical need Strong indications Growth in line with population
Slide 17: Acquisitions Have Driven Consolidation Among Competitors
Year Purchase Price ($mm) Target Year Purchase Price ($mm) Target Year Purchase Price ($mm) Target Year Purchase Price ($mm) Target 2008 388 2001 115 2004 47 Irvine Biomedical 1997 400 2009 225 2012 265 2005 237 2019 316 2013 275 2008 92 2022 925 2018 202 2008 250 2021 450 2013 331 2022 1,750 2014 2
Slide 18: Competitive Technology Landscape in Catheter Ablations
COMPETITIVE TECHNOLOGY LANDSCAPE IN CATHETER ABLATIONS: STABILITY DESPITE DISRUPTION1 18 Atrial Fibrillation Ventricular Tachycardia RF Cryoballoon PFA RF PFA JNJ MDT ABT BSX * - original intended use - label extension (established or in-progress) *+ + * - internal development
Slide 19: Adagio Solution: Durable, Contiguous, Transmural Lesions
ADAGIO SOLUTION: DURABLE, CONTIGUOUS, TRANSMURAL LESIONS …anywhere in the heart PFCA for atrial arrhythmias Cryopulse™ ULTC for atrial arrhythmias iCLAS™ and iCLAS™ Core Tx ULTC/PFCA for ventricular arrhythmias vCLAS™ 19
Slide 20: Adagio Medical: Outcomes-Focused Technology Differentiation
ADAGIO MEDICAL: OUTCOMES-FOCUSEDTECHNOLOGY DIFFERENTIATION 20 Durable, contiguous, transmural lesions… anywhere in the heart Comprehensive technology solution for advanced EP practice Compatible with commercial mapping systems Addressing drivers and limitations of therapy adoption to drive long-term
Slide 21: ULTC Portfolio for Cardiac Ablations
ULTC PORTFOLIO FOR CARDIAC ABLATIONS 21 Shaped Stylets Esophageal Warming Balloon iCLAS™ Cryoablation System is CE-Mark approved for the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL). In the
Slide 22: iCLAS ULTC: In a Class of Its Own
iCLAS ULTC: IN A CLASS OF ITS OWN iCLAS™ Cryoablation System is CE-Mark approved for the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL). In the U.S.A., iCLAS™ system is an investigational dev
Slide 23: Cryocure-2 Clinical Trial
CRYOCURE-2 CLINICAL TRIAL Cryomapping Cohort (n=65) Cryomapping Cohort Phrenic nerve palsy 1 Resolved during procedure 1 Resolved during follow-up 1 Unresolved 0 Total device-related events 1.5% No esophageal fistula, pericarditis, heart block 1.5% T. De Potter, et al. Ultralow Temperature Cryoablat
Slide 24: Redefining What's Possible for PsAF Patients
REDEFINING WHAT’S POSSIBLE FOR PsAF PATIENTS 25 50 75 100 Freedom from AF of AT/AF at 12 months (%) 68% n=102 Hybrid CONVERGE3 n=102 n=102 MANIFEST5 2023 85% n=44 ULTC CRYOCURE-26 2021 51% 58% 69% 71% n=196 n=3,133 n=339 n=7,502 Catheter Ablation RF1 Minimally Invasive Surgical Ablation1 w/o AAD w/
Slide 25: US iCLAS for Persistent AF IDE
US iCLAS FOR PERSISIENT AF IDE (NCT # 04061603) iCLAS™ Catheter Patients 183 PsAF Endpoints Procedural safety and chronic effectiveness Sites 20 (7 OUS) Data Readout Expected in Q2 2024 PMA Expected in Q1 2025 Note: Expectations are preliminary and subject to change. Please see Disclaimer Forward Lo
Slide 26: Cryocure-VT Study
CRYOCURE-VT STUDY(NCT # 04893317) Patients 64 patients, Rx-refractory persistent recurring monomorphic VT of both ischemic and non-ischemic etiology Endpoints Procedural safety, acute and chronic effectiveness Sites 9 centers Data Readout Expected in Q2 2024 CE-Mark Expected in Q1 2024 Next Steps En
Slide 27: vCLAS Cryocure-VT Clinical Trial: Redefining Risk/Benefit in VT Ablations
vCLAS™ CRYOCURE-VT CLINICAL TRIAL: REDEFINING RISK/BENEFIT IN VT ABLATIONS Titratable lesion depth and size Catheter stability during ablation Ability to ablate deep intramural scar No need to irrigate (important in HF patients) Differentiated and Highly Desirable Functional Performance Exceptional
Slide 28: What Is Pulsed Field Cryoablation?
WHAT IS PULSED FIELD CRYOABLATION?
Slide 29: PFCA: Modulating Tissue Impedance to Optimize PFA Energy Delivery
PFCA: MODULATING TISSUE IMPEDANCE TO OPTIMIZE PFA ENERGY DELIVERY Increased impedance of frozen tissue leads to reduced electric current for the same magnitude of electric field or and increased magnitude of electric field for the same magnitude of electric current as compared to normal temperature
Slide 30: PFCA: Combining Benefits of ULTC and Minimizing Limitations of PFA
PFCA: COMBINING THE BENEFITS OF ULTC AND MINIMIZING THE LIMITATIONS OF PFA PFCA vs ULTC: up to 85% shorter ablation cycle for the same lesion depth1 PFCA vs PFA2,3: Potentially deeper lesions Consistent tissue contact Contiguity “by design” No resistive heating effects No phrenic nerve capture No sk
Slide 31: Pre-Clinical Evidence: Shorter Ablations, Deeper Lesions, Enhanced Selectivity
PRE-CLINICAL EVIDENCE1: SHORTER ABLATIONS, DEEPER LESIONS, ENHANCED SELECTIVITY 31 PFCA LESION IN ~ 6mm THICK CTI LESION SIZE COMPARISON: PFCA vs PFA Δ=0.8 mm (n.s.) Δ=1.7 mm (n.s.) 92% TM* 100%TM* * transmurality Lesion depth enhancement due to pulsed field Lesion depth of 30 seconds, single freeze
Slide 32: EU PARALELL Trial
EU PARALELL TRIAL (NCT #05408754): Pulsed Field Ablation and Pulsed Field Cryoablation for Persistent Atrial Fibrillation PFA 1) Expectations are preliminary and subject to change. Please see Disclaimer -- Forward-Looking Statements on slide 2. 32 PFCA Patients 90 PsAF patients (60 PFCA and 30 PFA)
Slide 33: Near-Term Valuation-Driving Milestones
NEAR-TERM VALUATION-DRIVING MILESTONES Q1 Q2 Cryocure-VT Primary Endpoints Q1 vCLAS™ CE-Mark and EU launch 2024 iCLAS™ IDE Primary Endpoints iCLAS™ PMA Approval Q3 Cryopulse™ CE-Mark vCLAS™ PMA and US launch Note: Milestones are preliminary and subject to change. Please see Disclaimer – Forward-Look
Slide 34: Transaction Summary
34 TRANSACTION SUMMARY Assumes (i) price per share of $10, (ii) pro forma closing cash balance of $34 million, including $15 million in cash remaining in ARYA’s trust (assuming an additional 50% redemptions in connection with the Business Combination), (iii) $23 million convertible note bridge finan
Slide 35: Summary: Pure-Play Opportunity in Cardiac Ablations Market
SUMMARY: PURE-PLAY OPPORTUNITY IN CARDIAC ABLATIONS MARKET Unique technology poised to take significant market share in the Afib segment Highly differentiated product for VT A completely underserved market Muiltiple catalysts for the next several years in clinical data and product launches Pure-play
Slide 36: Thank You
‘THE COOLEST CATHETER ABLATION TECHNOLOGY %# Adagio: MEDICAL THANK YOU © COPYRIGHT 2024 ADAGIO MEDI 10 MEDICAL
Slide 37: Appendix I
APPENDIX I
Slide 38: Transaction Overview
38 TRANSACTION OVERVIEW Transaction Summary Adagio Medical, Inc. and ARYA Sciences Acquisition Corp IV (“ARYA”, Nasdaq: ARYD) propose to enter into a definitive business combination agreement ARYA is a special purpose acquisition company sponsored by Perceptive Advisors LLC The Post-Business Combina
Slide 39: Illustrative Pro Forma Ownership
ILLUSTRATIVE PRO FORMA OWNERSHIP1 39 All numbers adjusted for treasury stock method Subject to all assumptions and footnotes set forth on "Transaction Summary" and "Transaction Overview" slides. Illustrative per share price of Post-Business Combination company (to be a newly incorporated Delaware co
Slide 40: Highly Accomplished Executive Team
40 HIGHLY ACCOMPLISHED EXECUTIVE TEAM Olav Bergheim CEO & President Hakon Bergheim Chief Operating Officer John Dahldorf Chief Financial Officer Nabil Jubran Chief Compliance Officer Tim Glynn VP of Global Sales Ilya Grigorov Vice President, Global Marketing and Product Management Doug Kurschinski V
Slide 41: Selected Risk Factors
SELECTED RISK FACTORS 41 No representation or warranty (whether express or implied) has been made by ARYA, the Company, ListCo or any of their respective directors, officers, employees, affiliates, agents, advisors or representatives with respect to the proposed PIPE financing or Business Combinatio
Slide 42: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 42 The consummation of the Business Combination is subject to a number of conditions, and if those conditions are not satisfied or waived, the Business Combination may not be completed; Some of ARYA’s, the Company’s or the Post-Combination Company’s officers and directo
Slide 43: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 43 The proceeds held in ARYA’s trust account could be reduced and the per-share redemption amount received by ARYA shareholders may be less than $10.00 per share; The Nasdaq Stock Market LLC may delist ARYA’s Class A ordinary shares from its exchange prior to the closin
Slide 44: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 44 Upon executing a definitive agreement with respect to the Business Combination by and among the Company, ARYA and the Post-Business Combination Company, ARYA may be prohibited from entering into certain transactions that might otherwise be beneficial to it or its sha
Slide 45: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 45 If the Post-Combination Company estimates or judgments relating to its critical accounting policies are based on assumptions that change or prove to be incorrect, its results of operation could fall below its publicly announced guidance or the expectations of securit
Slide 46: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 46 Adagio is subject to regulation by the FDA or other regulatory authorities in the future and would be required to obtain prior approval or clearance by the FDA or other regulatory authorities, which could take significant time and expense and could fail to result in
Slide 47: Appendix II – Market Sources & Analyses
APPENDIX II – MARKET SOURCES & ANALYSES
Slide 48: Atrial Fibrillation
ATRIAL FIBRILLATION EDICAL'
Slide 49: Analysis of Epidemiology (US)
ANALYSIS OF EPIDEMIOLOGY (US) 25% (10-40%) of incident AF may be asymptomatic2 Current guidelines recommend catheter ablation of the AF as a 2nd-line therapy in patient with symptomatic disease3,4 49 2010 2030 CAGR, % Prevalence, millions 5.2 12.1 4.3% Incidence, millions 1.2 2.6 3.9% CAGR 2010 2011
Slide 50: Analysis of Current Volume of AF Ablations in the USA
ANALYSIS OF CURRENT VOLUME OF AF ABLATIONS IN THE USA Data Sources: Analysis of Medicare FFS Standard Analytical Files using CPT 936561 Limitations: Outpatient sample only Medicare FFS only Changes to coding during period of interest Required adjustments: Inpatient-outpatient mix, using sample of Me
Slide 51: Market Opportunity Assessment
MARKET OPPORTUNITY ASSESSMENT Assumptions: Outcomes with Adagio technology are sufficient to establish ablation as a 1st line therapy for symptomatic patients Calculation to be made on incidence basis, larger prevalence representing additional upside Opportunity in 2022-2023: Total incidence / curre
Slide 52: AF Market: Full Upside Requires Improvement in Long-Term Outcomes
AF MARKET: FULL UPSIDE REQUIRES IMPROVEMENT IN LONG-TERM OUTCOMES Cases (millions) 0.23 1.9 8.6 4% CAGR 4% CAGR 14% CAGR 52 6-8x upside in ablations if Class I indication as 1st line therapy – not achievable at current rates of recurrence, re-ablations and associated morbidity US AF Disease1 and Tre
Slide 53: Monomorphic Ventricular Tachycardia
MONOMORPHIC VENTRICULAR TACHYCARDIA
Slide 54: Catheter Ablation Indications in VT
CATHETER ABLATION INDICATIONS IN VT1,2 Highly heterogeneous patient population Complex treatment pathways, combination of ICD and Rx approaches In majority of cases ablation in Class II indication for failed/poorly tolerated Rx and poorly tolerated/deleterious ICD therapies 54 Ischemic Cardiomyopath
Slide 55: Epidemiology of VT Ablations
EPIDEMIOLOGY OF VT ABLATIONS 25% (14 - 35%) are patients without structural heart disease (few ICDs) 75% (65 - 86%) are patients with structural heart disease (mostly ICDs) 61% - 74% are patients with ischemic heart disease* Brigham and Women Hospital Cohort1 US Community Medicare Cohort2 German VT
Slide 56: Analysis of Current Volume of VT Ablations in the USA
ANALYSIS OF CURRENT VOLUME OF VT ABLATIONS IN THE USA Data sources: Analysis of Medicare FFS Standard Analytical Files using CPT 936541 Limitations: Outpatient sample only Medicare FFS only Changes to coding during period of interest Required adjustments: Inpatient-outpatient mix, using sample of Me
Slide 57: The Burden of Incident Idiopathic VTs
THE BURDEN OF INCIDENT IDIOPATHIC VTs Growth assumptions Extrapolation of 2013 observed growth incidence rate per disease state to 2022 Weighted average growth rate VT ablation eligibility assumptions Symptomatic PVCs: those with >20% burden Idiopathic VTs: those with >20% burden IVA-CM: 100% Total
Slide 58: Total Burden of VT in ICD Population
TOTAL BURDEN OF VT IN ICD POPULATION Estimated Volumes of US De-Novo ICD Implants1 Cumulative Rates of ICD Therapies as a Function of Time2 Appropriate therapies - 24% @ 3 years, linear assumption this reaches 30% @ 5 years, which is shorter than the average survival for ICD patients3 On the inciden
Slide 59: HF Hospitalizations in US
HF HOSPITALIZATIONS IN US The equivalent prevalence of patients most likely to experience VT due to reduced EF (,50%) in 2018: 3.24M = 6M x 54% 59 Tsao C, et al. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation 2022;145:e153-e169 Shah KS, Xu
Slide 60: Burden of VT in Hospitalized HF Patients
BURDEN OF VT IN HOSPITALIZED HF PATIENTS Estimated incidence of post-hospitalization VTs in HF patients is ~ 32K, based on 1.35M HF hospitalizations projected in 2022 based on 1.9% annual growth from 1.25M in 20183 60 1-year incidence - 5.4% Incidence of VTs After Advanced Heart Failure Hospitalizat
Slide 61: Summary Calculation of Incident Trigger VTs
SUMMARY CALCULATION OF INCIDENT “TRIGGER” VTs PROMPTING CONSIDERATION FOR ABLATION Market growth opportunity: All trigger VTs / Current VT ablations = 3.1x* Trigger VTs due to cardiomyopathy (HF hospitalizations + ICD Implants) / Current VT ablations = 1.9x** 2-3x range represents conservative asses
Slide 62: VT Market: Current Risk-Benefit Caps Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT CAPS ABLATION THERAPY PENETRATION 2% CAGR 7% CAGR 2-3x market growth opportunity* with improved ablation effectiveness and reduced risk profile within EP practice ~ 3,510(6) Reduction of symptomatic arrhythmic events (VT storms), ICD therapies, and removal vs escalati
Slide 63: Overall Market Sizing and Growth
OVERALL MARKET SIZING AND GROWTH
Slide 64: Overall Market Sizing
OVERALL MARKET SIZING JnJ, ABT and BSX report Electrophysiology revenue on quarterly basis using standard annual calendar Prior to 2023 JnJ reported revenue for Interventional Solutions segment, comprising predominantly of Electrophysiology + much smaller Neurovascular products. Starting 2023, Elect
Slide 65: Market Structure by Segment
MARKET STRUCTURE BY SEGMENT Normalization procedure is performed against total revenue of main market players to exclude line items representing non-essential or separately reported lines of business Ablation catheter revenue - $3.1 - $3.2B 65 Recalibrating Market to Exclude LAA, Cardiac Monitors an
Slide 66: Volumes and Growth Considerations
VOLUMES AND GROWTH CONSIDERATIONS 66 Note: Management's estimates which are subject to significant uncertainty and may prove to be incorrect. Please see Disclaimer - Management's Estimates on slide 2. (1) Adagio Medical Analysis of Medicare FFS and Commercial Claims (2) UK National Aurdit of Cardiac
Slide 67: Segmental Market Revenue
SEGMENTAL MARKET REVENUE 67 Based on prior assumptions and market estimates in slides 63-65 Growth potential per segment: PAF: 6-8x per slide #50 PsAF+VT 6-8x for PsAF (slide #50) 2-3x for VT (slide #60) Weighted potential is ~ 5x, suggest conservative assessment of 3x for combined Mid-range values
Slide 68: Competitive Devices and Indications
COMPETITIVE DEVICES AND INDICATIONS
Slide 69: Abbott / St. Jude Medical
ABBOTT / ST. JUDE MEDICAL Source: product Instructions For Use downloaded from US portion of the website. OUS indications for use may vary. 69
Slide 70: Expanded Indication for FlexAbility Catheter
EXPANDED INDICATION FOR FLEXABILITY CATHETER 70 Source: company website
Slide 71: Boston Scientific
BOSTON SCIENTIFIC Source: product Instructions For Use downloaded from US portion of the website. OUS indications for use may vary. Product Name US IFU Available Indicated Conditions Energy Source Blazer II®, Blazer II HTD® Temperature Ablation Catheters YES Accessory Pathway, AVNRT, AV Junction Abl
Slide 72: JnJ (Biosense Webster, Inc.)
JnJ (Biosense Webster, Inc.) Source: product Instructions For Use downloaded from US portion of the website. OUS indications for use may vary. 72
Slide 73: Original Indication for Thermocool Catheter
ORIGINAL INDICATION FOR THERMOCOOL CATHETER 73 Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030031
Slide 74: Medtronic
MEDTRONIC Source: product Instructions For Use downloaded from US portion of the website. OUS indications for use may vary. Product Name US IFU Available Indicated Conditions Energy Source AFFERA Sphere-9™ Mapping and Ablation Catheter YES PAF, PsAF, AFL, AT RF, PFA ARCTIC FRONT ADVANCE™ 2AF233, 2AF
Slide 75: Ablation Modalities Comparison
ABLATION MODALITIES COMPARISON
Slide 76: Using NHS Cost-Effectiveness Model for Technology Comparisons
USING NHS COST-EFFECTIVENESS MODEL FOR TECHNOLOGY COMPARISONS Conversions of data from source inputs into table: 1-year freedom from AF: 1 – 1st year AF recurrence Incremental mortality = Mortality – AAD Mortality For PFA values refer directly to quoted sources 76 1st year freedom from AF 27% 69% 68
Slide 77: Using NHS Cost-Effectiveness Model: Complications
USING NHS COST-EFFECTIVENESS MODEL FOR TECHNOLOGY COMPARISONS: COMPLICATIONS AAD RF point-by-point RF Multi-electrode Cryobaloon Laser Ablation Mini-thoracotomy Hybrid Ablation N/A 0.5% 0.5% 0.5% 0.5% N/A N/A N/A 1% 1% N/A 1% N/A N/A N/A N/A N/A 0.4% N/A N/A N/A N/A 1% 1% 1% 1% N/A N/A N/A N/A N/A 1