First and only contact force pulsed field
ablation (PFA) system designed to transform treatment for millions
with life-threatening ventricular arrhythmias.
Preliminary data of VCAS study will be presented
at HRS 2024 in Boston, Mass.
CARDIFF-BY-THE-SEA,
Calif., May 9, 2024 /PRNewswire/ -- Field
Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation
technology, today announced the initiation of its first-in-human
study for the FieldForce™ Ablation System at Na Homolce
Hospital in Prague, Czech
Republic. The Ventricular Catheter Ablation Study, VCAS,
will enroll up to 60 patients at up to 5 sites world-wide. The VCAS
investigational study is a critical step towards demonstrating
safety and performance of the FieldForce™ Ablation System,
developed specifically to address the limitations of existing
pulsed field ablation (PFA) and radiofrequency (RF) ablation
systems, including a more time efficient treatment protocol for the
treatment of ventricular arrhythmias. Preliminary results will be
presented on May 16, 2024, at the
Heart Rhythm Scientific Sessions in Boston, Mass.
"The FieldForce Ablation System, as the first
contact force PFA system for ventricular ablation, is demonstrating
significant promise early in our trials," said Vivek Reddy, MD, Director of Electrophysiology
for the Mount Sinai Health System. "This is my first experience
with a technology capable of achieving rapid complete transmural
left ventricular (LV) ablation, offering highly targeted treatment
options and an efficient workflow. Although these results are quite
preliminary, the potential of this system to revolutionize catheter
ablation of complex ventricular arrhythmias is profound,
potentially surpassing the current standard of care. The scientific
community will benefit from the comprehensive results from the
completed study."
PFA Adoption and Transition from Atrial to
Ventricular Arrhythmias
PFA has revolutionized the treatment of atrial
fibrillation (AF) over the past decade, thanks to pioneering work
by Field Medical CEO Steven
Mickelsen, MD, founder of Farapulse which was subsequently
acquired by Boston Scientific. His development of PFA technology
marked a significant shift in cardiac electrophysiology, enhancing
safety and reducing procedure times. This innovation set a new
standard in the industry, leading to widespread adoption and the
transformation of ablation practices. With PFA's proven success in
atrial settings, Field Medical is now poised to extend these
benefits to ventricular arrhythmias, signaling a pivotal evolution
in the management of complex ventricular cardiac conditions.
Ventricular Arrhythmia Burden
It is
estimated that ventricular arrhythmia impact over 6 million
patients in the US and Europe.
Ventricular arrhythmias, including ventricular tachycardia (VT) and
premature ventricular contractions (PVCs), and pose a substantial
risk, often leading to sudden cardiac death if not adequately
managed. Current ventricular catheter ablation methods involve
lengthy procedures and significant risks associated with thermal
ablation, like conventional RF ablation. Field Medical's PFA
technology aims to address these challenges by providing the first
and only contact force PFA catheter optimized to work in the
ventricle. This novel technology may enable predictable, time
efficient, and safe treatment option. FieldBending™ takes advantage
of non-intuitive physics to deliver intense, yet brief, electric
fields designed to safely reduce procedure times dramatically.
"Our vision at Field Medical is to transform VT
ablation into a widely available, one-hour outpatient procedure
with improved safety outcomes," said Steven
Mickelsen MD, CEO of Field Medical. "With the promising
early data for our VCAS study, in much the same way that PFA
transformed AF, the FieldForce Ablation System is optimized to
transform how ventricular arrhythmias are treated, offering hope to
millions of patients worldwide. With the strong investor support,
renown physician engagement and the groundbreaking potential of our
technology, we are set to redefine the standards of cardiac
ablation once again."
About VCAS Study
Field Medical's VCAS
Study is a pivotal segment of a prospective safety and feasibility
study, assessing the innovative FieldForce Ablation System in
patients with ventricular arrhythmias. The VCAS-I group focuses on
individuals suffering from ventricular tachycardia (VT), while the
VCAS-II group targets those experiencing frequent premature
ventricular complexes (PVCs). This study is instrumental in
evaluating the performance of Pulsed Field Ablation (PFA), thereby
potentially reducing procedural time compared to traditional
Radiofrequency (RF) ablation. The trial aims to demonstrate that
PFA can safely treat and improve overall outcomes for patients with
challenging ventricular arrhythmias. For study information, visit
clinicaltrials.gov NCT: NCT06203262.
About Field Medical,™
Inc.
Founded in 2022, Field Medical is at the
forefront of developing second-generation pulsed field ablation
(PFA) technologies, designed to meet the technical and safety
challenges of modern cardiac ablation procedures. Under the
leadership of Dr. Steven Mickelsen,
CEO, a globally recognized expert in pulsed electric field
technology, the company has pioneered the proprietary FieldBending™
technology. This innovation was developed to concentrate
therapeutic effects and reduce unwanted far-field effects, with the
potential to improve patient outcomes while simplifying the
clinical experience for physicians. Field Medical focuses on
expanding the applications of PFA beyond atrial fibrillation (AF)
to address complex ventricular arrhythmias—a condition affecting
over 6 million people in North
America and Europe alone,
often leading to sudden cardiac death, heart failure and
significant clinical symptoms if not managed effectively. The
company's comprehensive product portfolio, including the
FieldForce™ Catheter, FieldForce™ Ablation System, and the
FieldFlex™ Sheath, is specifically optimized to work in complex
ventricular environments. For more information,
visit www.fieldmedicalinc.com and follow us on LinkedIn
and X.
The FieldForce™ PFA Ablation System is an
investigational device and is limited by Federal (or United States) Law to investigational use.
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SOURCE Field Medical, Inc.