- Enrollment completed ahead of schedule in the global IDE for
Abbott's Volt™ PFA System
- Global FOCALFLEX trial now underway for Abbott's TactiFlex™ Duo
Ablation Catheter, Sensor Enabled™
- Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, receives
U.S. Food and Drug Administration clearance, begins commercial
launch
ABBOTT
PARK, Ill., Oct. 10,
2024 /PRNewswire/ -- Abbott (NYSE: ABT) announced
today it has achieved new major milestones to support the company's
growing suite of pulsed field ablation (PFA) solutions in
electrophysiology: early completion of enrollment in the VOLT-AF
IDE Study supporting the Volt™ PFA System, and the launch of the
FOCALFLEX trial to assess the company's TactiFlex™ Duo Ablation
Catheter, Sensor Enabled™ (SE), which will be used in the treatment
of patients with paroxysmal atrial fibrillation. Together, these
two studies represent significant advances for the future of two
Abbott PFA catheters, which are being developed as important tools
for physicians treating people with abnormal heart rhythms like
atrial fibrillation (AFib).
In addition, Abbott also announced U.S. Food and Drug
Administration (FDA) clearance of the company's Advisor™ HD Grid X
Mapping Catheter, Sensor Enabled™, which will further support
mapping of both PFA and radiofrequency (RF) ablation cases, where
visualization of cardiac anatomy is critical to ensure the best
outcomes for people undergoing ablation procedures.
"It was exciting to participate in the VOLT-AF IDE Study to help
assess a next-generation PFA catheter that incorporates new design
concepts we believe will advance PFA technology and improve patient
outcomes," said Monica Lo, M.D., an
electrophysiologist with Arkansas Heart Hospital who specializes in
complex arrhythmias. "Only through studies like VOLT-AF and
Abbott's new FOCALFLEX trial, can we fully understand and safely
deploy the next generation of AFib treatments to help people enjoy
life free from complex heart rhythm conditions."
New Advancement in Pulsed Field Ablation, Treating
AFib
Historically, patients requiring a cardiac
ablation procedure to treat conditions like AFib
received RF ablation, which uses heat to destroy
tissue responsible for erratic heart signals, or cryogenic
ablation, which freezes tissue. Instead of heat or extreme
cold, PFA uses high energy electrical pulses to
destroy the cells causing abnormal heart rhythms, which can reduce
the risk of damaging adjacent tissue in patients with complex
disease or anatomy.
PFA represents a promising opportunity to treat people with
abnormal heart rhythms with new technology that may offer safety
advantages* that can reduce known risks of traditional ablation
therapies. However, existing early-generation PFA systems have
limitations, including the lack of three-dimensional visualization
and coupling with a 3D cardiac mapping system*. Other limitations
that Abbott's PFA systems were designed to address include no
indication of catheter-tissue contact and repeat ablations to
ensure favorable patient outcomes*. Increased interest in Abbott's
PFA system propelled enrollment in the U.S. VOLT-AF IDE Study to be
completed four months ahead of the anticipated timeline, enrolling
almost 400 patients in just three months.
Abbott's investigational Volt PFA System was designed to
overcome prior limitations in PFA systems by pairing a
balloon-in-basket catheter with Abbott's EnSite™ X EP
System, an industry-leading heart mapping solution. The unique
basket shape of the catheter's energy delivery area paired with the
balloon are designed to effectively transfer Abbott's optimized
waveform energy to the tissue by ensuring better catheter contact
and stability during the procedure*. Another unique feature of
Abbott's PFA catheter is how the platform's PFA generator and the
EnSite X EP System are designed to give physicians the ability to
specifically target lesions and ablate the exact area(s) of the
heart that are triggering arrhythmia.
In addition to the VOLT-AF IDE Study, Abbott's global FOCALFLEX
Pulsed Field Ablation Study is also now underway to assess the
company's TactiFlex Duo Ablation Catheter, Sensor Enabled. This
catheter is designed as a dual-energy ablation solution offering
both PFA and RF energy delivery, and will also be assessed in the
FLEXPULSE IDE, which is expected to launch in the U.S. soon, with
about 200 patients at 25 sites.
Where the Volt PFA System is designed as a "single shot" PFA
approach, the TactiFlex Duo Ablation Catheter, SE is a "focal" or
"point-by-point" approach that aims to deliver the safety and
efficiency of PFA with more flexible and focused energy. Designed
on Abbott's TactiFlex Ablation Catheter, Sensor Enabled, known for
its stability during procedures due to its novel flexible tip, the
TactiFlex Duo Ablation Catheter, SE aims to offer physicians
another option for delivering PFA and/or RF to patients with
greater versatility to precisely target specific areas of tissue
within the heart.
"There's immense value in exploring different therapy options
for patients to treat abnormal heart rhythms because each case is
unique," said professor Prash
Sanders, M.B.B.S., Ph.D., director of the Centre for Heart
Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures
with the TactiFlex Duo Ablation Catheter, Sensor Enabled for the
FOCALFLEX trial. "Abbott improved upon limitations of
first-generation systems and has successfully advanced its approach
to PFA beyond those initial systems that have come to market."
Abbott's Advanced Cardiac Mapping Solutions Support Improved
Outcomes
As ablation innovations evolve, a key element of
effective treatment continues to be the use of heart mapping.
Accurate mapping for RF procedures has been critical in
electrophysiology, and the adoption of mapping for PFA procedures
continues to grow. Abbott has seen increased reliance on its
mapping technology as more physicians begin to explore the use of
PFA for patients.
With its recent FDA clearance, the Abbott Advisor HD Grid X
Mapping Catheter, Sensor Enabled, offers a first-of-its-kind
electrode configuration for high-density heart mapping. This design
is intended to make physicians more aware of electrical signals of
the heart, regardless of catheter placement during an ablation
procedure.
For U.S. important safety information go
to:
TactiFlex™ Ablation Catheter, Sensor
Enabled™
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/ablation-technology/tactiflex-se-ablation-catheter/indications-safety-warnings.html
Advisor™ HD Grid Mapping Catheter, Sensor
Enabled™
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/diagnostic-catheters/advisor-hd-grid/about.html
EnSite™ X EP System
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html
Investigational/Under-Development
Products
*Devices or products referenced
are INVESTIGATIONAL and/or UNDER DEVELOPMENT. Product
specifications or proposed intended uses are design goals and
subject to change.
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 114,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
View original
content:https://www.prnewswire.com/news-releases/abbott-advances-pulsed-field-ablation-clinical-studies-and-launches-new-technology-to-support-advanced-cardiac-mapping-302272620.html
SOURCE Abbott