Slide 1: Pacing Performance of the First Leadless Pacemaker Communicating with an S-ICD
Pacing Performance of the First Leadless Pacemaker Communicating with an S-ICD from the full cohort of the MODULAR ATP study 2024 ESC Late Breaking Clinical Trials Session: Smaller trials, trial updates, and other studies: devices, cardiac arrest and atrial fibrillation ablation Link to MODULAR ATP
Slide 2: EMPOWER LP Pacing Performance
EMPOWER LP Pacing Performance From the MODULAR ATP Trial Once the EMPOWER LP and mCRM system receive FDA approval, EMPOWER will be the first and only LP designed to be a standalone VVIR pacemaker that is also only compatible with all EMBLEM S-ICD devices as part of the mCRM system designed to delive
Slide 3: Trial Design Modular ATP trial
Trial Design Modular ATP trial • Inclusion: Enrollment ( up to 300) – New ICD indication or previous S-ICD Device(s) Implant or TV-ICD to be extracted EMPOWER LP and S-ICD implanted within 30 days of each other (if dual de novo) – High VT risk: History of • NSVT's + scar Pre-Discharge System Testing
Slide 4: Results: Modular ATP Study Cohort
Results Modular ATP Study Cohort • Ongoing Study Patient Characteristics N=293 • Database snapshot 24 Jan 2024 Age, years 59±12 • Median follow-up: 8.9 months Enrolled N=293 Female—# (%) 51 (17%) Device(s) Implanted N=281 Body-mass index, kg/m2 30±6 Secondary prevention—# (%) 126 (43%) Pre-Discharge
Slide 5: EMPOWER Delivery Catheter
EMPOWER Delivery Catheter* Design Features and Procedural Steps for Increased Patient Safety Flexible Sleeve Axially Deploying Talons Implantation in MODULAR ATP Patient LAO Soft, contoured tip designed to reduce pressure on cardiac tissue EMPOWER MDT Micra • Designed to penetrate ~2 mm axially into
Slide 6: Results in larger patient cohort (n=280)
Results in larger patient cohort (n=280) Leadless Pacemaker Implantations16 Procedure Time* Demonstrated 100% successful LP implantation with no repositions in 71% N: 105 95 19 22 14 25 of patients. 120 Minutes 39 (14%) 80 LP only 41 (15%) >1 Repositions 87 99 1 Reposition 40 68 LP + S-ICD 45 57 29
Slide 7: Results in larger patient cohort (n=281): Complications
Results in larger patient cohort (n=281) Complications16 The EMPOWER System demonstrated 97.4% 7 (2.6%) of patients experienced 7 freedom from major leadless pacemaker related complications during LP implantation. complications in the larger patient cohort (274/281) Number Patients— with no deaths a
Slide 8: Results in larger patient cohort (n=280): Chronic Retrievals
Results in larger patient cohort (n=280) Chronic Retrievals16 In 1% of the patients (n=3), the EMPOWER LP required removal for clinical reasons and were successfully retrieved with no complications. Procedure Retrieval Reason time, post implantation 4 months Inadvertent implant in LV through PFO 12
Slide 9: Results in larger patient cohort: Pacing Performance
Results in larger patient cohort Pacing Performance16 The EMPOWER LP showed Stable pacing parameters at 6 months analyzed off the larger patient cohort.16 EMPOWER LP has consistent electrical performance over time including pacing capture threshold 0.55 ± 0.47 V measured at 0.4 ms, sensed amplitude
Slide 10: Pacing Performance Results: Rate Response Sub-study
Pacing Performance Results Rate Response Sub-study 16 Performance Endpoint 2: The LP accelerometer-based Patient Characteristics N=35 rate response was validated on a treadmill test (n=35) and Age–yr 54±11 met endpoint with a mean Metabolic-Chronotropic Relation Female 4 (11.4) (MCR) slope of 0.96 f
Slide 11: Pacing Performance Results: Holter Sub-study
Pacing Performance Results Holter Sub-study16 The MODULAR ATP trial included ICD patients who were not pacer dependent. Therefore, the Holter monitor sub-study included an initial in-office period of 25-35 minutes during which a patient’s pacemaker was programmed with a lower rate limit (LRL) higher
Slide 12: MODULAR ATP LP Summary
MODULAR ATP LP Summary 6-months Follow-Up16 Implantation and Safety – 100% successful LP implantation – >70% at the first location, with no reposition. – Major lead-related complications in 7 patients (2.6%) Pacing Performance – Stable pacing parameters – Rate response study results support LP accel
Slide 13: mRCM System – designed for the future of personalized patient care
mRCM System – designed for the future of personalized patient care • Upon the EMPOWER Leadless Pacemaker* and mCRM system* receiving FDA approval, EMPOWER will be the first and only LP designed to be a standalone VVIR pacemaker** that is compatible with all existing EMBLEM S-ICD devices as part of t
Slide 14: Practical Implications of the MODULAR AT EMPOWER LP Pacing Performance Data
Practical Implications of the MODULAR AT EMPOWER LP Pacing Performance Data “Successful performance of the EMPOWER Leadless Pacemaker in the MODULAR ATP study provides crucial evidence that it will function as a standalone pacemaker to treat bradycardia, in addition to its anti-tachycardia pacing ca
Slide 15: References
References 1. Lloyd MS, Brisben AJ, Reddy VY, et al. Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm O2. 2023;4(7):448- 456. Published 2023 Jun 2. doi:10.1016/j.
Slide 16: EMBLEM MRI S-ICD System safety information
EMBLEM MRI S-ICD System CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” and MRI Technical Guide for more information on Indications, Contraindications, Warnings, Precautions, Adverse Eve