2013-01-15 15:34:18 -
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 ablation(1, 2), and better treatment outcomes than drug
therapies on the market(3). 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(®) 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;
* The FlexCath Advance((TM)) Steerable Sheath, which helps deliver and
position the cryoballoon in the left atrium;
* The Achieve(®) Mapping Catheter, an intra-cardiac electrophysiology
recording catheter used to assess pulmonary vein isolation when treating
paroxysmal atrial fibrillation;
* 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
therapy(4), and if left untreated, patients have up to a five times higher risk
of stroke(5) 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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Source: Medtronic, Inc. via Thomson Reuters ONE
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