Medtronic Announces Launch of FlexCath Advance(TM) Steerable Sheath, Enhancing the Arctic Front Advance(TM) Cryoballoon System

Tue Jan 15, 2013 9:30am EST

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Second-Generation Sheath May Facilitate Easier Access to the Inferior Veins When Treating
Paroxysmal Atrial Fibrillation

MINNEAPOLIS - Jan. 15, 2013 - Medtronic, Inc. (NYSE: MDT) today announced Food and Drug
Administration (FDA) clearance and U.S. launch of the FlexCath Advance(TM) Steerable Sheath, a new
enhancement to the Arctic Front Advance(TM) Cryoballoon System. This second-generation sheath has
an increased degree of deflection and response, providing greater ease compared to the previous
generation in reaching the inferior veins of the heart when delivering and positioning the
cryoballoon catheter in the left atrium to treat paroxysmal atrial fibrillation (PAF).

The Arctic Front Advance System is used in minimally invasive procedures to isolate the pulmonary
veins using coolant. Delivered via a catheter, the cryoballoon technology is associated with
faster procedure times than point-by-point radiofrequency ablation1, 2, and better treatment
outcomes than drug therapies on the market3. Additionally, the Arctic Front Advance cryoballoon
features the new EvenCool(TM) Cryo Technology, which optimizes the delivery of coolant inside the
balloon; the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary
veins, and improves physicians' ability to treat patients with complicated anatomies as compared
to the original Arctic Front(R) Cryoballoon. 

"The FlexCath Advance sheath's ability to maneuver the catheter with a greater range of deflection
may help reach the inferior veins and facilitate placement of the cryoballoon, which is a critical
step to ensuring treatment success," said Suneet Mittal, M.D., director, Electrophysiology
Laboratory, Arrhythmia Institute of the Valley Health System, Ridgewood, NJ. 

The FlexCath Advance Steerable Sheath has a deflection of 135 degrees, compared to the 90 degree
deflection rate of its first-generation predecessor. This greater degree of deflection may allow
the cryoballoon to be better maneuvered and positioned within the heart to achieve maximum
treatment benefit. The sheath includes the following features:

*Radiopaque marker band at 5 millimeters to provide enhanced visibility under fluoroscopy;
*Deflection mechanism with an ergonomic handle that optimizes the movement of the sheath; and
*Hemostasis valve that allows for introduction, withdrawal and exchanging of catheters and
guidewires, while preventing air insertion and minimizing blood loss.

"Building upon the Arctic Front System's proven platform, the FlexCath Advance Steerable Sheath
augments the overall efficiency of the procedure," said Reggie Groves, vice president and general
manager of Medtronic's AF Solutions division. "It completes the Arctic Front Advance System and is
the fourth new product we have launched in the U.S. market in two years."

About the Arctic Front Advance System
The Arctic Front Advance Cryoballoon System and its predecessor have been used to treat more than
50,000 patients in approximately 500 centers across 32 countries. The technologies currently
offered include:

*The Arctic Front Advance Cryoballoon, which inflates and fills with coolant to isolate the
pulmonary veins for the treatment of PAF;
*(TM)The FlexCath Advance Steerable Sheath, which helps deliver and position the cryoballoon in
the left atrium;
*(R)The Achieve Mapping Catheter, an intra-cardiac electrophysiology recording catheter used to
assess pulmonary vein isolation when treating paroxysmal atrial fibrillation;
*(R)The Freezor MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to
provide additional ablations, as needed; and
*The CryoConsole, which houses the coolant, electrical and mechanical components that run the
catheters during a cryoablation procedure.

About Atrial Fibrillation
Atrial fibrillation is the most common and one of the most undertreated heart rhythm disorders,
affecting more than 7 million people worldwide. It is estimated that half of all diagnosed atrial
fibrillation patients fail drug therapy4, and if left untreated, patients have up to a five times
higher risk of stroke5 and an increased chance of developing heart failure. PAF is a type of
disease in which irregular heartbeats in the upper chambers start and stop suddenly on their own,
usually for minutes or days at a time.

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.

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.

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.

-end-

 

1  Kojodjojo P, O'Neill MD, Lim PB, et al. Pulmonary venous isolation by antral ablation with a
large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term
outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation.
Heart. September 2010;96(17):1379-1384.
2 Sorgente A, Chierchia GB, Capulzini L, et al. Atrial fibrillation ablation: a single center
comparison between remote magnetic navigation, cryoballoon and conventional manual pulmonary vein
isolation. Indian Pacing Electrophysiol J. December 26, 2010:10(11):486-495.
3 Medtronic, Inc. Arctic Front Cardiac CryoAblation Catheter clinical reports, in support of FDA
premarket approval.
4 JAMA 2001; 285:2370-5.
5 Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906. 
  

Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492

Jeff Warren
Investor Relations
+1-763-505-2696


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