Medtronic Plc. · NYSE:MDT
Medtronic — Investor Presentation (November 2022)
14 slides from Medtronic's investor presentation, November 2022
Slide 1: Model 3830 left bundle branch area pacing indication expansion
Model 3830 Left bundle branch area pacing indication expansion
Slide 2: 3830 left bundle branch area labeling expansion approved for bradycardia patients
The 3830 left bundle branch area labeling expansion has been approved for bradycardia patients only, as an alternative to right ventricular pacing in a single- or dual-chamber pacing system. Conduction system pacing as an alternative to CRT for patients with prolonged QRS duration is considered off-
Slide 3: FDA approves 3830 lead placement for conduction system pacing
FDA approves 3830 lead placement for conduction system pacing Indications for use1 The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to right ven
Slide 4: Opportunity to improve patient outcomes with conduction system pacing
Opportunity to improve patient outcomes with conduction system pacing Studies have reported deleterious effects of right ventricular pacing, including increased risk of pacing-induced cardiomyopathy, heart failure,1 and ventricular dyssynchrony.2 Conduction system pacing allows for a more physiologi
Slide 5: SelectSecure Model 3830 MRI leads
SelectSecure™ Model 3830 MRI leads Proven safe. Proven effective. Proven design. Fixed helix • Increased helix stability at implant relative to extendable/retractable helix leads1 • Reduced fracture risk relative to extendable/retractable helix leads1 Lumenless design • 4.1 French, isodiametric lead
Slide 6: The 3830 LBBAP real-world evidence evaluation
The 3830 LBBAP real-world evidence evaluation Three analyses1 encompassing > 20K global patients Systematic review, Medtronic Medtronic meta-analysis Product Surveillance CareLink™ Registry 6,061 patients 312 patients 14,933 patients 45 centers 25 centers 887 centers Implant success rate, Retrospect
Slide 7: The Model 3830 lead is safe and effective for LBBAP pacing in bradycardia-indicated patients
The Model 3830 lead is safe and effective for LBBAP pacing in bradycardia-indicated patients 3830 LBBAP real-world evidence evaluation High implant success rate1 92.7% average implant success rate among bradycardia-indicated patients (meta-analysis) Low procedural adverse event rate1 2.5% total proc
Slide 8: High implant success rate with 3830 at LBBAP
High implant success rate with 3830 at LBBAP1 3830 LBBAP real-world evidence evaluation 92.7% implant success rate among bradycardia- indicated patients 11.3 average minutes fluoroscopy time 84.4 minutes total procedure time 117 ms average paced QRS duration at implant 1 SelectSecure 3830 Left Bundl
Slide 9: Low procedural adverse event rate
Low procedural adverse event rate1 3830 LBBAP real-world evidence evaluation 2.5% total procedural adverse event 3830 LBBAP lead complication rate2 rate at implant (meta-analysis) 1.6% total procedural septal perforation rate at implant, yet none with clinical sequela (meta-analysis) 97.0% patients
Slide 10: Electrical performance of 3830 LBBAP
Electrical performance of 3830 LBBAP 3830 LBBAP real-world evidence evaluation Pacing thresholds < 1.0 V average at ≤ 1.0 ms pulse width through 12 months (PSR) and 18 months (CareLink™) follow-up1 R-wave sensing > 12.0 mV average through 12 months (PSR) and 18 months (CareLink™) follow-up1 Average
Slide 11: Robust mechanical performance supports Model 3830 for LBBAP procedures
Robust mechanical performance supports Model 3830 for LBBAP procedures Test methodology developed from clinical CT data sets for 10-year simulated mechanical testing (> 400 M cycles)1 Use conditions IMAGE-LBB study included n = 43 patients with 3830 in LBB • Acute stresses at implant • Lead tip dept
Slide 12: The road to conduction system pacing with SelectSecure 3830
The road to conduction system pacing with SelectSecure™ 3830 C304-HIS FDA approved 2022 350,000 3830 HBP FDA approved Total implants Huang, et al. first report of LBBAP 175,000 3830 LBBAP FDA approved 3830 FDA HBP Global approved Grand Rounds 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Slide 13: Approved for LBBAP
SelectSecure™ MRI SureScan™ 3830 Lead Approved for LBBAP Proven safe. Proven effective. Proven design. 13 Model 3830 left bundle branch area pacing indication expansion | November 2022
Slide 14: Brief Statement
Brief Statement Select Secure and SelectSecure MRI SureScan Pacing and Sensing Lead Indications: Medtronic SelectSecure family of leads has application where implantable atrial or ventricular, Potential Complications: Potential patient-related complications related to the use of transvenous leads in