System Technology

IMPLANTED SYSTEM COMPONENTS

RECEIVER ELECTRODE

T R A N S M I T T E R

Phased array ultrasound transmitter is implanted sub-muscular over a cardiac echo window. Synchronizes with an RV pacing pulse to transmit ultrasound energy to the receiver electrode to provide Bi-V endocardial pacing.

Secure AttachmentEndothelializes for a low risk of thromboembolic events

Anchors onto endocardial wall with 5 nitinol tines

Passive device with no need for replacement

Full endothelialization in animal testing at 30 to 45 days*

B A T T E R Y Implanted subcutaneously on the left mid axillary line, powers the transmitter.

R E C E I V E R E L E C T R O D E Implanted onto the endocardium, the receiver electrode converts ultrasound energy into electrical energy to pace the left ventricle.

C O - I M P L A N T D E V I C E Co-implanted pacemaker, ICD or CRT paces the right ventricle.

SITE

EVA

LUAT

ION

ANCH

ORI

NG

ANCH

ORE

D

Small SizeExpected to diminish the need for chronic anticoagulation

LENGTH OF BODY: 9.1mmDIAMETER: 2.7mm

WEIGHT: 0.12 gramsVOLUME: 0.05 cc

* Echt DS, Moore D, Cowan M, Valli VE, Whitehair, JG, Willis NP. Chronic implantation of leadless pacing electrodes in the left ventricle of a goat model. Heart Rhythm 2010;7:S451-2.

Caution: Not commercially available in the United States

LV ENDOCARDIUM WALL

Image taken from In-vivo study (caprine) at

45 days post implant

ENDO

THEL

IALI

ZED

ACTUAL SIZE

DELIVERY SYSTEM

WiSE CRT IMPLANTATION PROCESS

Designed for Safe Receiver Electrode Placement^

Innovative inflatable polyester balloon, creates an atraumatic tip for safety during anchoring of the receiver electrode

Radiopaque materials enhance visualization of sheath tip position during implant

Direct connection of the cathode tip of the Receiver Electrode to EP systems for analysis of local EGM signals, pacing and threshold testing^ Results from the SELECT-LV trial confirm all Receiver Electrode devices were

safely placed without pericardial effusion events (N=34)

Stage 2: Receiver Electrode Implantation

➊ Introduce the 12F Delivery System into the LV via a retrograde aortic approach

➋ Navigate the Delivery System to a target site using fluoroscopy

➌ Evaluate conventional pacing capture thresholds, local electrograms, and/or hemodynamics of pacing the site prior to anchoring the receiver electrode

➍ Once a suitable site has been selected, anchor the receiver electrode into the LV wall, detach and release it from the Delivery System

Sheath’s ballooon on LV wall (with Transmitter and the RV lead in view)

Contrast injection is used to confirm receiver electrode is anchored into LV wall

Stage 1: Transmitter and Battery Implantation

➊ Make incisions above the identified Transmitter implantation site and on the mid-axillary line

➋ Create pockets for the transmitter and the battery➌ Create a tunnel between pockets for the transmitter cable➍ Secure the transmitter to the intercostal muscle ➎ Connect the transmitter cable to the battery and secure

the battery in the subcutaneous pocket Submuscular transmitter implantation with pocket formed

through dissection down to the intercostal muscle

RIB INTERCOSTAL MUSCLE RIB

MUSCLE MUSCLE

FAT FATSKIN SKIN

POCKET

Stage 0: Pre-implant Assessment

Performed by a cardiac sonographer in an outpatient setting using standard TTE

Intercostal spaces are assessed for transmitter implantation to identify acoustic transmission paths that are free of lung and rib

Select a location for the Transmitter implant over ICS 4 through 7

ICS 4

ICS 5

ICS 6

ICS 7

EBR Systems, Inc. 686 W. Maude Ave., Suite 102, Sunnyvale, CA 94085 USA www.ebrsystemsinc.com© 2016 EBR Systems, Inc. All Rights Reserved. WiSE is a trademark of EBR Systems, Inc.Caution: Not commercially available in the United States

RETRACTABLE 8F CATHETER WITH MOUNTED RECEIVER ELECTRODE

ATRAUMATIC BALLOON INFLATABLE WITH CONTRAST

12F STEERABLE DELIVERY SHEATH

MC-03242 Rev. A