Medtronic Plc. · NYSE:MDT

Medtronic — Technical Presentation (April 2022)

16 slides from Medtronic's technical presentation, April 2022

  1. Slide 1: 5-Year Results from the IN.PACT Global Study Pre-specified Cohorts

    5-Year Results from the IN.PACT Global Study Pre-specified Cohorts In-Stent Restenosis, Chronic Total Occlusions, and Long Lesions Gunnar Tepe MD Department of Diagnostic and Interventional Radiology at RoMed Clinic Rosenheim​, Rosenheim, DE

  2. Slide 2: Disclosure

    Disclosure <<Firstname Lastname>>  I have the following potential conflicts of interest to report:  Receipt of grants/research support  Receipt of honoraria and travel support  Participation in a company-sponsored speaker bureau  Employment in industry  Shareholder in a healthcare company  Ow

  3. Slide 3: Background

    Background • The treatment of peripheral arterial disease (PAD) in patients with multiple comorbidities is challenging and remains a global health concern, impacting approximately 236 million people worldwide.1 • Drug-coated balloons (DCB) emerged as a novel endovascular treatment option a decade ag

  4. Slide 4: Robust Clinical Program

    Robust Clinical Program IN.PACT DCB Portfolio - Clinical Data for the SFA RCTs + Pivotal Registration Studies Real-World Studies IN.PACT IN.PACT IN.PACT IN.PACT Global Study ‡ SFA Japan China† (EU+US) RCT† Pre-specified Regional RCT† Imaging Subsets Cohorts Gender † Subset Long Lesion Belgian Diabet

  5. Slide 5: IN.PACT Global Study

    IN.PACT Global Study† 1535 Subjects Consented • Real-world Full Clinical Cohort 150 mm 1416 Subjects DCB Cohort • Prospective (1406 ITT)Ω M. Brodmann4 • Multicenter (64 global sites) Non-imaging cohort LINC 2020 • Single arm • Complex femoropopliteal lesions Pre- de novo ISR Long Lesion CTO • Indepe

  6. Slide 6: Independently Assessed Outcomes: Effectiveness and Safety

    IN.PACT Global Study Independently Assessed Outcomes Freedom from clinically driven target lesion Effectiveness revascularization† through 60 months Composite of freedom from device- and procedure- related death through 30 days, and freedom from Safety major target limb amputation & clinically drive

  7. Slide 7: Baseline Patient Characteristics Reflective of Real-world Patients

    IN.PACT Global: Pre-specified Cohorts Baseline Patient Characteristics Reflective of Real-world Patients de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) Characteristics N=132 Subjects N=158 Subjects N=127 Subjects Age (Years) 67.8 ± 10.1 69.6 ± 10.7 67.4 ± 10.5 Male 68.9 (91/132) 66.5 (105/158) 68.5 (

  8. Slide 8: Additional Baseline Characteristics

    IN.PACT Global: Pre-specified Cohorts Additional Baseline Characteristics de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) Characteristics N=132 Subjects N=158 Subjects N=127 Subjects Previous Peripheral Revascularization 100.0 (132/132) 55.7 (88/158) 33.1 (42/127) Concomitant BTK Disease 43.0 (55/128)

  9. Slide 9: Lesion Characteristics

    IN.PACT Global: Pre-specified Cohorts Lesion Characteristics de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) N=132 Subjects N=158 Subjects N=127 Subjects Lesion Characteristics N=150 Lesions† N=162 Lesions† N=129 Lesions† N=145 Lesions‡ N=165 Lesions‡ N=128 Lesions‡ Lesion Type † 0.0 (0/150) 83.3 (135

  10. Slide 10: Procedure Characteristics

    IN.PACT Global: Pre-specified Cohorts Procedure Characteristics de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) Procedural Characteristics N=132 Subjects N=158 Subjects N=127 Subjects N=150 Lesions Ω N=162 Lesions Ω N=129 Lesions Ω Device Success † 99.6 (283/284) 99.6 (444/446) 99.3 (289/291) Procedur

  11. Slide 11: 5-Year Effectiveness Outcomes

    IN.PACT Global: Pre-specified Cohorts 5-Year Effectiveness Outcomes Freedom from CD-TLR through 5 Years Long Lesion CTO de novo ISR IN.PACT Global Full Cohort 5-year Freedom from CD-TLR rate: 69.4% 11 11 IN.PACT Global Study: CTO ISR LL | Tepe | 501043 | 04/2022

  12. Slide 12: Additional 5-Year Effectiveness Outcomes

    IN.PACT Global: Pre-specified Cohorts Additional 5-Year Effectiveness Outcomes de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) Cumulative Incidence by Kaplan-Meier Estimate N=132 Subjects N=158 Subjects N=127 Subjects CD-TLR† (%) (Number of subjects with event) 42.0 (50) 32.7 (41) 30.2 (32) Any TLR‡ (

  13. Slide 13: 5-Year Safety Outcomes

    IN.PACT Global: Pre-specified Cohorts 5-Year Safety Outcomes de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) Kaplan-Meier Estimated % N=132 Subjects N=158 Subjects N=127 Subjects Safety Composite† % (n) ‡ 56.0 (52) 65.7(43) 69.8 (32) † Safety composite endpoint consists of: Freedom from device- and pr

  14. Slide 14: Additional 5-Year Safety Outcomes

    IN.PACT Global: Pre-specified Cohorts Additional 5-Year Safety Outcomes 5-Year Kaplan-Meier de novo ISR Long Lesion (≥15 cm) CTO (≥ 5 cm) Cumulative Incidence N=132 Subjects N=158 Subjects N=127 Subjects Major Adverse Events † 53.1 (65) 48.9 (67) 43.0 (48) CEC-Adjudicated All-cause Death 16.7 (20) 2

  15. Slide 15: All-Cause Death through Years with Additional Vital Status

    IN.PACT Global: Pre-specified Cohorts All-Cause Death through 5 Years with Additional Vital Status Freedom from All Cause Mortality through 5 Years 96.4% Vital Status Follow-up † Long Lesion CTO de novo ISR † Vital Status number based on the IN.PACT Global Study full ITT cohort 15 15 IN.PACT Global

  16. Slide 16: Conclusions

    Conclusions • Real-world data from the IN.PACT Global Study continue to confirm long-term clinical safety and effectiveness of the IN.PACT Admiral drug-coated balloon when used to treat complex lesions • High 5-year freedom from clinically driven TLR was demonstrated in all three pre-specified cohor

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