Medtronic Receives FDA Approval for Trial Evaluating New Energy Source with Pulsed Electric Fields to Treat Atrial Fibrillati...
January 23 2020 - 10:00AM
Medtronic plc (NYSE:MDT) today announced that it received
approval from the U.S. Food and Drug Administration (FDA) to
proceed with an investigational device exemption (IDE)
trial to evaluate the safety and effectiveness of
the PulseSelect™ Pulsed Field Ablation (PFA) System, a new
technology that uses pulsed electric fields to treat atrial
fibrillation. First procedures in the trial were performed in
December 2019 by Bradley Wilsmore, M.D., at John Hunter Hospital,
New Lambton Heights, NSW, Australia and in January by Atul Verma,
M.D., the principal investigator (PI) for the study, at Southlake
Regional Health Centre in Newmarket, Canada.
PFA uses pulsed electric fields to ablate or
create lesions and scar tissue to interrupt irregular electrical
pathways in the heart and the triggers of atrial fibrillation.
However, unlike traditional methods of ablation that heat the
tissue (radio frequency) or cool the tissue (cryo) to ablate, PFA
is non-thermal and selectively targets cardiomyocytes (heart muscle
cells) while avoiding other types of tissue.
“This study will evaluate a new energy source that
may treat atrial fibrillation and potentially address the risks
that have been associated with other ablation technologies, such as
unintended tissue damage,” said Verma. “The rigorous pre-clinical
research to get us to these first procedures has been impressive
and we are excited to support the development of more clinical
evidence.”
In September 2018, Medtronic was granted
Breakthrough Device designation from the FDA for the PFA technology
for the treatment of drug refractory recurrent symptomatic atrial
fibrillation. Worldwide, the PFA system is investigational and not
approved for sale or distribution.
PULSED AF is a prospective, multi-center,
non-randomized, unblinded and worldwide study that will enroll
patients who will be treated with the Medtronic PulseSelect
PFA System.
“As a global leader in the treatment of cardiac
arrythmias, Medtronic is constantly evaluating new and
existing therapies to better meet the needs of patients and the
physicians who care for them,” said Rebecca Seidel, vice president
and general manager in the Atrial Fibrillation Solutions division,
which is part of the Cardiac and Vascular Group at Medtronic. “The
PULSED AF study is another example of our commitment to meaningful
innovation and a major step forward in the development of a diverse
set of therapy options for atrial fibrillation 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 MedtronicMedtronic 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 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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-
Allison KyriagisPublic Relations+1-612-750-6061
Kathleen JanaszPublic Relations+1-612-743-8995
Ryan WeispfenningInvestor Relations+1-763-505-4626
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