Slide 1: 1 year Outcomes of the C-GUARDIANS Pivotal IDE Trial of the C-GUARD MicroNet Stent
1 year Outcomes of the C- GUARDIANS Pivotal IDE Trial of the C-GUARD MicroNet Stent D. Chris Metzger, MD OhioHealth Riverside Methodist Hospital Columbus, Ohio, USA On Behalf of the C-GUARDIANS Investigators bl
Slide 2: Disclosures
Disclosures * Symposia Honoraria & Proctor Fees: ¢ Abbott, Endologix * Symposia Honoraria: * Boston Scientific, Medtronic, Penumbra, Shockwave * VIVA Board Member * National PI/Co-PI: C-GUARDIANS, Confidence, SAPPHIRE WW, CANOPY, PERFORMANCE 3 * Stock Options: INSPIRE MD * Research Grants, Stocks, E
Slide 3: Two-Thirds of 30-Day Stroke Events Occur after the CAS Procedure
Two-Thirds of 30-Day Stroke Events Occur after the CAS Procedure Neurological events
Slide 4: Area Comparison (mm2)
Area Comparison (mm2) Open cell stent * Bench test results may not necessarily be indicative of clinical performance. Stent images approximately at scale but not exact * Average in lesion at expanded state Lip Cc
Slide 5: The CGuard Stent: Designed to Address Peri-procedural Microembolization with Mesh Technology
The CGuard Stent: Designed to Address Peri-procedural Microembolization with Mesh Technology peg tombur Conventional Open Cell Stent (15 GEN): Larger cell sizes increase risk of plaque protrusion MicroNet captures and locks thrombus & plaque material against the arterial wall, deterring debris from
Slide 6: M, 52y, Right Hemisph. Stroke days before
M, 52y, Right Hemisph. Stroke 5 days before Case courtesy of Dr. Piotr Musialek Designed to minimize plaque protrusion during and after the procedure CAUTION: The CGua
Slide 7: Clinical Data Supporting CGuard Peri-procedural Safety
Clinical Data Supporting CGuard Peri-procedural Safety Study CARENET PARADIGM CASANA WISSGOTT! IRONGUARD | WISSGOTT II IRONGUARD 2 GREEK Study SIBERIA TOTAL ‘Schofer J. etal JAC Cardiovasc. Inter. 2015. CCasana, Reta. Eur.J. Vase. Endovasc. 2017. Musialek, Petal. Interv. Cardiol. 2016 Wissgott,C. et
Slide 8: Extensive body of literature from independent studies in peer-reviewed journals
Extensive body of literature from independent studies in peer-reviewed journals CARENET 0.0% (0) IRONGUARD | 199 3.01% (6) IRONGUARD I 726 2.20% (16) PARADIGM, 101 0.0% (0) SIBERIA 50 0.0% (0) 1.99% (22) |. Schofer, J. et al, JACC Cardiovasc. Interv. 2035. Speziale, F. et al. Eurolntervention. 18 3.
Slide 9: C-GUARDIANS Pivotal IDE Approval Trial
C-GUARDIANS Pivotal IDE Approval Trial Theoretical concept of conformable stent combined with maximal plaque coverage, and experience with: ¢ 50,000+ stents sold since 2015 CE Mark in Europe ¢ Extensive 30- day, 1 year- , and 5-year peer-reviewed published data * All serve as precursors for the IDE
Slide 10: Prospective, multicenter, international, single-arm clinical trial
Prospective, multicenter, international, single-arm clinical trial comparing the primary endpoint to a performance goal derived from literature Evaluate the safety and efficacy of the CGuard Prime™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patie
Slide 11: C-GUARDIANS: Other Trial Features
C-GUARDIANS: Other Trial Features Technical success and treatment success Death, stroke, minor stroke, major stroke, MI through 30-day Ipsilateral stroke through 30 days, 1-, 2-, 3-year follow-up TLR through 1-, 2-, 3-year follow-up Distal EPD (NAV6), Proximal Protection (MoMA), or both DAPT require
Slide 12: Patient Demographics
Patient Demographics % Symptomatic Diabetes Mellitus Dyslipidemia CAUTION: Th
Slide 13: CAUTION: The CGuard Stent System is Investigational Use Only and Not for Sale in the USA
CAUTION: The CGuard Stent System is Investigational Use Only and Not for Sale in the USA
Slide 14: Procedural Data
Procedural Data
Slide 15: C-GUARDIANS: 30-Day Major Adverse Events (LBCT VIVA 2023)
C-GUARDIANS: 30-Day Major Adverse Events (LBCT VIVA 2023) 30-day S/D/MI * Hierarchical patient count (each patient first occurrence of the most serious event). * Non-hierarchical: event count (multiple events in each patient are counted individually). * Per Protocol Analysi 51 patient (did not take
Slide 16: C-GUARDIANS Trial 1-Year Primary Endpoint Results
C-GUARDIANS Trial 1-Year Primary Endpoint Results * Kaplan-Meier estimate for all 1-year endpoints ** Per Protocol Analysis excludes 15 patients with Major Protocol Deviations The CEC independently adjudicated all neurological, cardiac events: + 1 minor stroke (retinal) on POD 189. + 1major stroke o
Slide 17: C-GUARDIANS: 30-Day DSMI in Context of CAS, TCAR Trials
C-GUARDIANS: 30-Day DSMI in Context of CAS, TCAR Trials
Slide 18: C-GUARDIANS: 1-Year Outcomes in Context
C-GUARDIANS: 1-Year Outcomes in Context (D/S/MI @ 30 days and ipsilateral stroke to 1 year) fond 12.50% 9.60% 4.70% 4.60% 2.67% 1.95% ‘Sapphire (2002) Archer (2003) MAVERIC (2004) CABERNET (2004) PROTECT (2008) PERFORMANCE 2 {| CGUARDIANS (2024) (2023) |
Slide 19: Summary of C-GUARDIANS Year Outcomes
Summary of C-GUARDIANS 1 Year Outcomes ° 30-Day Outcomes * DSMI: ITT 0.95%, PP 0.63% * No MI, No contralateral stroke ¢ 1-Year Outcomes Follow up compliance rate at 1-year: 97% 30-day DSMI or ipsilateral stroke between 31 and 365 days: *ITT 1.95%, PP 1.7% * TLR (any target revascularization up to 36
Slide 20: Conclusions
Conclusions * The C-GUARDIANS Pivotal IDE results demonstrate extremely low event rates for 30 —day stroke/death/MI (0.95%) and 1 -year S/D/MI at 30 dates plus ipsilateral strokes (1.95%), representing the lowest event rates in published trials of CAS, TCAR, and CEA ¢ These data are consistent with
Slide 21: Thank You for Your Attention!
Thank You for Your Attention!