Safe, efficient, and effective treatment for
both paroxysmal and persistent atrial fibrillation
DUBLIN, Dec. 13,
2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a
global leader in healthcare technology, today announced that the
United States Food and Drug Administration (FDA) has approved the
PulseSelect Pulsed Field Ablation (PFA) System for the treatment of
both paroxysmal and persistent atrial fibrillation (AF). This is
the first PFA technology to receive FDA approval and follows the
recent European CE (Conformité Européenne) Mark of the PulseSelect
PFA system in November.
"Launching the first FDA-approved PFA technology is not just a
milestone; the PulseSelect PFA system is setting a new standard in
safety for AF ablation with excellent efficacy and
efficiency1. It's a major step towards fulfilling
our vision of providing disruptive electrophysiology solutions for
patients," said Rebecca Seidel, SVP
and President of the Cardiac Ablation Solutions business, which is
part of the Cardiovascular Portfolio. "The PulseSelect PFA system,
together with the CE Marked Affera™ mapping and ablation system and
our strong Cryo platform, enables us to provide a broad portfolio
of solutions to clinicians and their patients, all developed with
years of research and supported by compelling scientific
evidence."
The PulseSelect PFA system was engineered with differentiated
safety features and provides rapid, effective pulmonary vein
isolation (PVI) through consistent and predictable energy delivery
and catheter maneuverability. The system is designed to enable a
seamless transition to PFA in a clinician's preferred
workflow2. The PulseSelect PFA system's safety,
efficacy, and efficiency is supported by the PULSED AF study, which
showed a 0.7% safety event rate and clinical success rates of 80%
in both paroxysmal and persistent AF patients1.
"The PulseSelect PFA system ushers the EP community to a new era
of safe, effective, and efficient AF ablation that overcomes many
challenges in our current practice," said Dr. Amin Al-Ahmad, clinical cardiac
electrophysiologist at St. David's Medical Center in Austin, TX and one of 67 global operators in
the PULSED AF trial. "In my clinical experience with the catheter,
it was designed for AF ablation procedures. The learning curve in
using the catheter and system is short, and the catheter enables
the operator to deliver fast and controlled pulsed field energy for
AF ablation."
The PulseSelect PFA system also includes the following:
- Designed as a plug-and-play system, PulseSelect can be used
with any mapping system or with just fluoroscopy2.
- Built-in safety features such as a phrenic nerve test pulse, a
non-therapeutic low voltage pulse that provides a preemptive
assessment of catheter proximity to the phrenic nerve prior to
delivering a therapeutic application.
- Fixed spacing for the nine-electrode catheter, which produces a
predictable and consistent electric field for contiguous
ablation2. In addition to ablation, the nine electrodes
can also be used for pacing and sensing.
- The small, 9Fr bidirectional catheter enhances maneuverability
and access to various anatomical structures and is compatible with
a 10Fr sheath, including the custom bidirectional FlexCath Contour™
sheath.
"We are thrilled to see the continuous innovation of our legacy
Cryoablation portfolio alongside the approval of the PulseSelect
PFA system in the U.S.," said Khaldoun
Tarakji, MD MPH, Chief Medical Officer of the Cardiac
Ablation Solutions business at Medtronic. "Every patient deserves
the best care. What motivates all of us at Medtronic is the
privilege of serving patients by empowering electrophysiologists
globally with the safest and most effective ablation technologies
that seamlessly integrate with their workflows and enable them to
tailor therapy based on their patients' needs."
The PulseSelect PFA system is also the first FDA
Breakthrough-designated PFA technology to be approved. The
designation is intended to help patients gain more timely access to
medical devices that have the potential to make a significant
impact in the diagnosis or treatment of life-threatening
conditions.
Commercialization of the PulseSelect PFA system will start in
early 2024.
About Atrial Fibrillation and Pulsed Field Ablation
AF
is one of the most common and undertreated heart rhythm disorders,
affecting more than 60 million people
worldwide3. AF is a progressive disease, meaning it
can become worse over time and can increase the risk of serious
complications including heart failure, stroke and increased risk of
death.4-7 Current ablation technologies rely on thermal
effects to target cardiac tissue and risk damage to additional
collateral structures in the heart. PFA is a breakthrough ablation
technology that uses pulsed electric fields to efficiently isolate
the pulmonary veins for the treatment of AF. Because the mechanism
of cell death is non-thermal, the risk of collateral structure
damage is potentially lower.
About Medtronic
Bold thinking. Bolder actions. We
are Medtronic. Medtronic plc, headquartered in Dublin,
Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 95,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, surgical robotics,
insulin pumps, surgical tools, patient monitoring systems, and
more. Powered by our diverse knowledge, insatiable curiosity, and
desire to help all those who need it, we deliver innovative
technologies that transform the lives of two people every second,
every hour, every day. Expect more from us as we empower
insight-driven care, experiences that put people first, and better
outcomes for our world. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE:MDT),
visit www.Medtronic.com, and follow @Medtronic on
LinkedIn.
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.
- Verma A, et al. Circulation. 2023;147:1422-1432
- Medtronic data on file. November
2023.
- Roth GA, Mensah GA, Johnson CO et al. Global Burden of
Cardiovascular Diseases and Risk Factors, 1990-2019: Update From
the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
- Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in
patients diagnosed with first atrial fibrillation: a 21-year
community-based study. J Am Coll Cardiol 2007;49:986-92.
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines
for the diagnosis and management of atrial fibrillation developed
in collaboration with the European Association of Cardio-Thoracic
Surgery (EACTS). Eur Heart J 2020.
- Wolf PA, Abbott RD, Kannel WB.
Atrial fibrillation as an independent risk factor for stroke: the
Framingham Study. Stroke 1991;22:983-8.
- Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation
patterns and risks of subsequent stroke, heart failure, or death in
the community. J Am Heart Assoc 2013;2:e000126
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SOURCE Medtronic plc