FDA Approves Expanded Indication for Medtronic Freezor® Xtra Cryoablation Catheter
17 February 2017 - 4:00AM
Demonstrated Safe
and Effective for Treating Patients with Abnormal Heart Rhythm of
AVNRT
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 Freezor
Xtra 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.
About Medtronic
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
results.
-end-
1 Wetzel GT.
Atrioventricular Node Reentry Supraventricular Tachycardia.
Medscape, 2016.
2 Porter
M, et al. Influence of age and gender on the mechanism of
supraventricular tachycardia. Heart Rhythm (2004), 4: 393-396
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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