leadless - idss 2020 · a leadless intracardiac transcatheter pacing system. n eng j med. published...
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Leadless
pacemaker
Yuval Goldshmid
25/Feb/2020
2
1959
PACING INNOVATION
HISTORICAL PERSPECTIVE
20131970
First ExternalPacemaker
Synergist
1989
Activitrax
1986
Byrel
1979
5858
1970
5800
1959
Chardack - Greatbatch
1960
MicroMinix
1990
Elite
1991
Kappa™
1998
Thera™
1995
Adapta™
2006
EnPulse
2004
First Implantable Pacemaker
Pediatric AsynchronousPulse Generator
Rate response Radicallysmaller size
1st Micro-processor-based, Mode switching
Full automaticity
MVP™, Fullautomaticity
Rate response via activity & minute ventilation
Dual chamber rate response
2011
EnRhythmMRI™
1st MRI-Conditional
Advisa MRI™
2nd MRI-Conditional
2013
Micra™
TranscatheterPacing System
2015
HISTORICAL PERSPECTIVE
4
Micra™ Medtronic
Nanostim
Abbott
NEW OPPORTUNITIES TO: REDEFINE THE PATIENT EXPERIENCE
▪ Potential to increase pacemaker patient satisfaction ▪ No chest scar, No bump, and No visible or physical reminder▪ Minimally-invasive procedure
▪ Potential for fewer post-implant activity restrictions
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NEW OPPORTUNITIES TO: REDUCE COMPLICATIONS ASSOCIATED WITH TRADITIONAL PACING TECHNOLOGY
Pocket Related Complications
8% at 5 years with traditional technology 1,2
▪ Infection
▪ Hematoma
▪ Erosion
Lead Related Complications
11% at 5 years with traditional technology 1,2
▪ Fractures
▪ Insulation breaches
▪ Venous thrombosis and obstruction
▪ Tricuspid regurgitation
1 Udo et al. FOLLOWPACE. Heart Rhythm 2012;9:728–735. 2 Historical Control for Micra Study (6 pacemaker studies)
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MINIATURIZED
Completely self contained within the heart, no leads required.
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MINIATURIZED
93% smaller than other modern-day pacemakers1, Micra™ is the world’s smallest pacemaker2, yet it offers a complete set of features.
1 Williams, Eric, Whiting, Jon; Micra Transcatheter Pacing System Size Comparison, November 2014, Medtronic Data on File.2 Nippoldt, Doug, Whiting, Jon; Micra Transcatheter Pacing System Device Volume Characterization Comparison, November 2014,
Medtronic Data on File.
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MINIATURIZED
New ultra low power circuit design delivers a 12 year longevity1, 2
▪ Proprietary Li/SVO CFx battery: chemistry has high energy density
▪ Fixation: Stable fixation separated from electrode interface to enable low and stable thresholds. 3
▪ Capture management: Exclusive hourly safety margin confirmation optimizes pacing output
1 Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Eng J Med. Published online November 9, 20152 Steinwender C, et al. Early Electrical Performance of a Novel Leadless Transcatheter Pacemaker System: Data from the Micra Clinical Study, Presented at HRS 2015 (P009-29).3 Bonner MD, Eggen M, Hilpisch K, et al. Performance of the Medtronic Micra Transcatheter Pacemaker in a GLP Study. Heart Rhythm. May 2014:11(5):S19.
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INTRODUCING THE MICRA™ TRANSCATHETER PACING SYSTEM (TPS)
Micra Cardiocapsule
Micra Delivery Catheter
MicraIntroducer
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MICRA™ CARDIOCAPSULE1
Size▪ Volume: 0.8 cc▪ Mass: 2 g▪ Length: 25.9 mm▪ Width: 20 Fr
Battery▪ 12 year longevity1
Capabilities
• Pacing Mode: VVIR• Bipolar sensing • Programmable• MRI SureScan™, allowing 1.5 T or 3 T full body
MRI scans • Capture Management™
• Rate Response• Diagnostics: battery status, threshold, impedance, % paced• Device can be manually deactivated and automatically deactivates at EOS
1 Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Eng J Med. Published online November 9, 2015
FlexFix™ Nitinol Tines
18mm electrode to ring spacing
Cathode
Anode
Proximal Retrieval Feature
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DELIVERY CATHETER AND MICRA INTRODUCER1
Delivery Catheter
▪ 105 cm long catheter system with a handle that controls deflection and deployment of the Micra Cardiocapsule1
Micra™ Introducer
▪ 56 cm working length, with extended distal taper
▪ 23 Fr inner diameter (27 Fr outer diameter)
▪ Hydrophilic coated sheath
1 Medtronic Micra MC1VR01 Clinician Manual, November 2014
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THE MICRA PROCEDURE
SOPHISTICATED PROCEDURE
Engineered for a minimally invasive approach
▪ Integrated delivery system facilitates a streamlined implant procedure via a percutaneous, femoral approach
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SOPHISTICATED FIXATION
FlexFix™ Tines
▪ Atraumatic, FlexFix nitinol tines provide secure capsule placement1
▪ Four, active nitinol tines gently self expand to ensure consistent deployment
▪ Multidimensional redundancy: 2 tines have 15x the holding force necessary to hold the device in place2
1 Eggen, M. et al. Design and evaluation of a novel fixation mechanism for a transcatheter pacemaker. IEEE, Vol. 62, No. 9, September 2015. 2 Grubac, V, et al. Analysis of the Micra fixation mechanism use conditions and holding energy requirements. Presented at EHRA Europace 2014 (Abstract 16-56).
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TEST FIXATIONAND ELECTRICALS
Optimal electrode tissue interface allows for low and stable chronic thresholds.1
1 Bonner MD, Eggen M, Hilpisch K, et al. Performance of the Medtronic Micra Transcatheter Pacemaker in a GLP Study. Heart Rhythm. May 2014:11(5):S19.
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NAVIGATION TO TARGET LOCATION
Minimally invasive, integrated delivery system facilitates a streamlined implant procedure.
DEVICE DEPLOYMENT
Linear, one-step deployment ensures controlled capsule placement, no torque required.1
Catheter is designed to minimize tip force
▪ Femoral approach and flexible distal catheter design result in an 11% push efficiency2
1 Eggen, Mike. FlexFix Tine Design. April 2015. Medtronic Data on File.2 Bonner, M, Evaluation of Risk of Micra Delivery System Perforation. November 2014. Medtronic Data on File.
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ATRAUMATIC TINESDESIGNED FOR REPOSITIONING
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DEVICE LIFE CYCLE MANAGEMENT OPTIONS
Options:
• The Micra design incorporates a proximal retrieval feature to enable acute retrieval. 1
• Micra can be turned OFF and an additional Micra can be added
• Micra can be turned OFF and a traditional system or Upgrade can be implanted
1Medtronic Micra MC1VR01 Clinician Manual,
Proximal Retrieval Feature
PATIENTS TREATED WORLDWIDE
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Patients treated with Micra
EMEA: >14,000 (Europe, Middle East & Africa)
Worldwide: >50,000
MICRA TECHNOLOGY ROADMAP
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MICRA TECHNOLOGY ROADMAP
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PAST PRESENT AND FUTURE
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PAST PRESENT AND FUTURE
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Yuval Goldshmid
Thank you
PAST PRESENT AND FUTURE
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