Demonstrated Safe and Effective for Treating Patients with Abnormal Heart Rhythm
DUBLIN - Feb. 16, 2017 - Medtronic plc (NYSE: MDT) today announced the U.S. Food
and Drug Administration (FDA) has approved its Freezor( )Xtra Cryoablation
Catheter for treating patients with atrioventricular nodal re-entrant
tachycardia (AVNRT), a life-threatening abnormal heart rhythm. The Freezor Xtra
Catheter is a flexible, single-use device used to freeze cardiac tissue and
block unnecessary electrical signals within the heart.
AVNRT is an abnormal heart rhythm, or arrhythmia; approximately 319,000 people
live with AVNRT and more than 49,000 people are diagnosed each year.(1,2)
"The expanded indication for this catheter will allow more patients to benefit
from a safe and effective therapy that can prevent heart racing, and allow them
to get back to their normal activities," said Peter Wells, M.D., heart rhythm
doctor at Baylor Heart and Vascular Hospital, Dallas, and principal investigator
of the ICY-AVNRT clinical trial.
The expanded indication is supported by data from the Intracardiac CrYoablation
for AtrioVentricular Nodal Reentrant Tachycardia (ICY-AVNRT) clinical study,
which demonstrated safety and effectiveness of the Freezor Xtra Catheter for the
treatment of patients with AVNRT. With 397 enrolled patients in 34 clinical
trial sites across the U.S. and Canada, the study showed freedom from AVNRT was
92.6 percent at six months post-procedure. All of the safety endpoints were
met, with no primary safety events related to the Freezor Xtra Catheter.
"Medtronic is pleased with the FDA's decision to approve the expanded use of the
FreezorXtra Catheter for the AVNRT patient population," said Colleen Fowler,
vice president and general manager of the AF Solutions business, part of the
Cardiac and Vascular Group at Medtronic. "This treatment option expands our
efforts to improve care for these patients."
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 of the highest
quality that deliver clinical and economic value to healthcare consumers and
providers around the world.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among
the world's largest medical technology, services and solutions companies -
alleviating pain, restoring health and extending life for millions of people
around the world. Medtronic employs more than 88,000 people worldwide, serving
physicians, hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
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
(1) Wetzel GT. Atrioventricular Node Reentry Supraventricular Tachycardia.
(2)Porter M, et al. Influence of age and gender on the mechanism of
supraventricular tachycardia. Heart Rhythm (2004), 4: 393-396
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Source: Medtronic plc via GlobeNewswire