FIRE AND ICE Data Show Fewer Repeat Ablations and Hospitalizations for AF Patients Treated with Medtronic Cryoballoon
June 10 2016 - 4:00AM
Secondary Analyses
Presented at Cardiostim 2016 Highlight Positive, Real-World Patient
Outcomes
DUBLIN AND NICE, FRANCE - June
10, 2016 - Medtronic plc (NYSE: MDT) today announced findings
from the secondary analyses of the FIRE AND
ICE clinical trial that demonstrate significantly fewer repeat
ablations and lower hospitalization rates for patients with
paroxysmal atrial fibrillation (PAF) treated with the Arctic
Front® Cryoballoon
Catheter Family compared to the ThermoCool® line of
radiofrequency (RF) ablation catheters. The results were presented
today at a late-breaking session at CARDIOSTIM-EHRA EUROPACE
2016.
Primary results from the FIRE AND ICE trial were
previously published in The New England Journal of
Medicine and showed comparable safety and effectiveness of
Cryoballoon ablation and RF catheter ablation.
Predefined secondary endpoints presented at
Cardiostim include cardiovascular-related hospitalizations, repeat
ablations, and quality of life. Other analyses of interest focused
on all-cause hospitalizations and direct current cardioversion.
Procedure Efficacy and
Performance Results
The FIRE AND ICE trial demonstrated significant reductions in the
Cryoballoon group in the areas important to patients, including 34
percent fewer cardiovascular-related hospitalizations and 33
percent fewer repeat ablations. Additional analyses showed 21
percent fewer all-cause hospitalizations and 50 percent fewer
direct current cardioversions.
-
The Cryoballoon group had 49 repeat ablations in
44 patients (44/374; 11.8 percent); the RF catheter group
experienced 70 repeat ablations in 66 patients (66/376; 17.6
percent) (p=0.03).
-
In the Cryoballoon group, 139
cardiovascular-related hospitalizations occurred in 89 patients
(23.8 percent); by comparison, 203 cardiovascular-related
hospitalizations occurred in 135 patients (35.9 percent) in the RF
catheter group (p<0.01).
-
With regard to all-cause hospitalizations, 122
patients in the Cryoballoon group were hospitalized 210 times (32.6
percent) compared to 156 patients in the RF ablation group who were
hospitalized 267 times (41.5 percent) (p=0.01).
-
Direct current cardioversion, a procedure that
shocks the heart in an attempt to convert an abnormal heart rhythm
back to a normal rhythm, was higher for patients treated by the RF
catheter (6.4 percent) as compared to patients treated by the
Cryoballoon (3.2 percent) (p=0.04).
Patient Quality of Life
Results
Patient quality of life was assessed at baseline and every six
months after the index ablation procedure for up to 30 months.The
study showed an improvement in mental and physical quality of life
for patients in both treatment groups at six months, which was
maintained throughout the follow-up period.
"Today's findings continue to demonstrate the
power of the Cryoballoon in making a difference to patients and
physicians," said Colleen Fowler, vice president and general
manager of the AF Solutions business, part of the Cardiac and
Vascular Group at Medtronic. "Offering a technology that has fewer
hospitalizations, repeat procedures and shorter procedure times
than conventional point-by-point technology is meaningful to
patient care."
About FIRE AND ICE
FIRE AND ICE is the largest multicenter,
prospective, randomized study to compare Cryoballoon ablation and
point-by-point RF ablation for the treatment of PAF. This landmark,
head-to-head, non-inferiority study, published in The New England Journal of Medicine, enrolled 769
patients. The trial met its primary efficacy endpoint of showing
non-inferiority for Cryoballoon compared to RF catheter ablation in
reducing arrhythmia recurrence and the need for antiarrhythmic drug
therapy and/or re-ablation, but with shorter and more consistent
procedure times when using the Cryoballoon. It also met its primary
safety endpoint of time to first all-cause death, all-cause
stroke/TIA, or treatment-related serious adverse events.
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 85,000 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-
Third party trademarks used in
this release are trademarks of their respective owners.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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