CardioGuide System Enables Real-Time Navigation of Left Ventricular Leads During Medtronic CRT Implants

Tue Apr 9, 2013 9:00am EDT

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Marketwired

Medtronic of Canada Ltd.

April 9, 2013 - 09:00:19 AM

CardioGuide System Enables Real-Time Navigation of Left Ventricular Leads
During Medtronic CRT Implants

MINNEAPOLIS, MINNESOTA and BRAMPTON, ONTARIO--(Marketwired - April 9, 2013) -
Medtronic, Inc. (NYSE:MDT) today announced market release of the
CardioGuide(TM) Implant System, a novel real-time navigation system for
cardiac resynchronization therapy pacemakers and defibrillators (CRT-P and
CRT-D), in the United States and Canada. The system helps physicians determine
the most appropriate location for left-ventricular (LV) lead placement by
generating 3-D images of the cardiac veins; enhanced software for the system
will be commercially available later this year that also analyzes the motion
of select cardiac vessels on the left side of the heart. Clinical studies have
shown that appropriate left-ventricular lead placement may improve CRT
response in heart failure patients(1,2,3).

"The future of LV lead implantation requires an individual-patient-tailored
approach. We know from studies that the best location for one patient can be
the least effective for another," said Raymond Yee, M.D., Director, Arrhythmia
Service, London Health Sciences Centre, Ontario, Canada. "This system provides
clinical and physiologic data acquired during the CRT case to ensure that the
optimal lead and tools are used to implant the lead at the targeted location,
potentially helping improve patient response to the therapy."

CRT is a safe and effective treatment(4) for indicated heart failure patients,
proven to significantly reduce mortality and heart failure hospitalization
rates(4). However, approximately one-third of patients who receive a CRT
device do not fully benefit from this therapy(5); appropriate lead placement
may improve patient outcomes. The CardioGuide System's 3-D imaging software
projects a roadmap and the targeted lead placement onto an overlay of the
patient's heart, and tracks the real-time location of the electrodes within
the body using fluoroscopy. This enables the implanting physician to confirm
that the lead is placed in the targeted location.

In addition, left-ventricular lead positioning is known to be time-consuming
for physicians. In approximately 43 percent of cases, patient procedure times
extend to two hours or more(5). Given its ability to guide lead placement in
real-time, the CardioGuide System may help reduce overall implant procedure
times. 

"The CardioGuide Implant System offers the medical community a viable,
cost-effective solution for targeting left-ventricular lead placement, the
cornerstone of successful CRT therapy," said David Steinhaus, M.D., Vice
President and General Manager, Heart Failure, and Medical Director for the
Cardiac Rhythm Disease Management business. "This is yet another example of
our commitment to offering physicians the most advanced medical technology
available to help improve CRT response and ensure the best quality of care for
all heart failure patients."

The CardioGuide System is part of a comprehensive approach Medtronic has
undertaken to deliver solutions to optimize CRT response and manage heart
failure patients at every stage of care. The system is compatible with all
Medtronic CRT devices, including the Viva(R)/Brava(R) portfolio available in
Europe and Canada. The CardioGuide Implant System received a Cardiostim
Innovation Award from the European Society of Cardiology in 2012, and is
available in the United States and Canada. Medtronic has an exclusive
licensing agreement with Paieon to market the CardioGuide Implant System
worldwide.

About the CardioGuide(TM) Implant System

The CardioGuide Implant System is designed to analyze fluoroscopy images and
create 3-D imaging of the heart for transvenous left-ventricular lead
implants. The components currently offered in the system include:



--  CardioGuide software and work station, which includes a dedicated
    computer and monitor that are used to calculate anatomical measurements
    and provide lead navigation support. 
--  Physician monitor, which displays the implant system inside the
    procedure room or cath lab. 
--  Tablet computer, which includes a touch screen and stylus and is used as
    a tableside console in the procedure room. 
--  Markers that are placed on the patient's chest to automatically
    calibrate the system.



In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and
providers worldwide.

About Medtronic of Canada Ltd.

Medtronic of Canada Ltd. is a trusted Canadian leader delivering innovative
health system solutions and advanced medical technologies to alleviate pain,
restore health, and extend life in the areas of cardiovascular medicine,
diabetes, spinal and neurosurgery, and ear, nose, throat surgery. Medtronic is
proud to employ more than 700 Canadians. Headquartered in Brampton, Ontario,
Medtronic has regional offices in Vancouver and Montreal, including a
manufacturing facility, Medtronic CryoCath, located in Pointe-Claire, Quebec.
www.medtronic.ca

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the
global leader in medical technology - alleviating pain, restoring health, and
extending life for millions of people around the world.

About Paieon Inc.

Paieon is a medical imaging company pioneering in the field of real-time
imaging for cardiac navigation. Paieon's mission is to develop progressive
cardiac navigation imaging solutions that bridge between the imaging world and
implantable devices, adding its valuable decision tools to support physicians
and their patients throughout interventional cardiac procedures.

Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities
and Exchange Commission. Actual results may differ materially from anticipated
results.

(1) Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in
Chronic Heart Failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.

(2) Saba S, Marek J, Schwartzmann D, et al. Echocardiography-Guided Left
Ventricular Lead Placement for Cardiac Resynchronization Terhapy: Results of
the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region
(STARTER) Trial. Circulation Heart Failure, online, 2013.

(3) Khan FZ, Virdee MS, Palmer CR, et al. Targeted left ventricular lead
placement to guide cardiac resynchronization therapy: the TARGET study: a
randomized, controlled trial. JACC. April 24, 2012;59(17):1509-18.

(4) Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS focused update of
the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities:
a report of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines. Circulation.
2012;126:1784-1800.

(5) Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac
resynchronization on morbidity and mortality in heart failure. N Engl J Med.
April 14, 2005;352(15):1539-1549.

(6) Medtronic internal research. (Cardiac Navigation System Value Proposition
and Pricing, December 2011).


FOR FURTHER INFORMATION PLEASE CONTACT: 
Medtronic of Canada Ltd.
MaryBeth McKenzie
Public Relations
+1 416-579-2823


Medtronic of Canada Ltd.
Jeff Warren
Investor Relations
+1-763-505-2696
www.medtronic.ca
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