leadless - idss 2020 · a leadless intracardiac transcatheter pacing system. n eng j med. published...

Leadless

pacemaker

Yuval Goldshmid

25/Feb/2020

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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

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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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