In the pivotal phase of the admIRE trial, the
VARIPULSE™ Platform demonstrated 85% peak primary effectiveness
with minimal adverse events, short PFA application times, and low
fluoroscopy exposure
Additional findings presented at HRS show the
potential of the VARIPULSE™ Platform in treating patients with
diverse arrythmias
IRVINE,
Calif., May 17, 2024 /PRNewswire/ -- Biosense
Webster, Inc., a global leader in cardiac arrhythmia treatment and
part of Johnson & Johnson MedTech, announced late-breaking
results from the pivotal phase of the admIRE pivotal clinical
trial, plus additional results from the VIRTUE study, presented at
the Heart Rhythm Society (HRS) Annual Meeting in Boston from May
16-19. Both studies explore the potential of the VARIPULSE™
pulsed field ablation (PFA) Platform to treat patients with cardiac
arrythmias including atrial fibrillation (AFib).
Twelve-month data from the pivotal phase of the admIRE study
assessed the safety and efficacy of the VARIPULSE™ Platform among
277 participants with paroxysmal AFib treated across 30 healthcare
centers in the U.S. by 39 operators. Presentation highlights
include:1
- 75% overall primary effectiveness successi
- 85% peak primary effectiveness for participants receiving 73-96
PFA applications for PVIii
- 2.9% overall primary adverse event rateiii
- There were no reported incidents of device or procedure-related
death, atrioesophageal fistula, coronary spasm, or
hemolysis-related renal failure requiring hemodialysis
- 100% of patients achieved acute procedural
success;iv 98% first-pass isolation recorded per
veinv
- Median procedure time of 81 minutes in pulmonary vein isolation
(PVI)-only procedures, 90 minutes in all procedures, and a
fluoroscopy time of 7 minutes
- 43% of patients were able to leave the healthcare facility on
the same day as their procedure
- 25% of procedures were performed without fluoroscopy, with no
impact to safety or efficacy due to the full integration of the
VARIPULSE™ Platform with the CARTO™ 3 System
The admIRE study evaluated the safety and efficacy of the
VARIPULSE™ Platform to treat paroxysmal atrial fibrillation (PAF),
and supported the recent Premarket Approval Application to the U.S.
Food & Drug Administration for the VARIPULSE™ Platform.
The VARIPULSE™ Platform is not for sale in the United States
"The admIRE study demonstrated good safety and effectiveness
results. The primary effectiveness success was 74.6%, and among the
subset of participants receiving 73-96 PFA applications for
PVI, 85% achieved success. Primary safety events occurred in 2.9%,
demonstrating promising evidence of the capabilities of the
VARIPLUSE Platform," said Vivek
Reddy, M.D., director of electrophysiology, Mount Sinai
Fuster Heart Hospital, New York.
"Differentiated by its unique CARTO™ 3 System integration, this was
the first PFA IDE study to support a substantial number of
fluoro-free procedures; 25% of procedures were performed with zero
fluoroscopy."
Findings from the admIRE study build on previous data from the
inspIRE study published earlier this year, which evaluated the
efficacy and safety of the VARIPULSE™ Platform in patients with PAF
in Europe and Canada. These latest data are part of Biosense
Webster's comprehensive global clinical trial strategy across PFA
solutions including the recently announced three-month results from
the SmartfIRE clinical trial published in April 2024, the SmartPulse study announced in
December 2023, and the Omny-IRE
clinical trial announced in September
2023.
Data from the VIRTUE study were also presented at the HRS Annual
Meeting, evaluating the further use of the investigational
VARIPULSE™ Platform in patients more reflective of usual clinical
practice, including patients with paroxysmal and persistent atrial
fibrillation as well atypical atrial flutter, either as first-time
or redo procedures. The inclusion criteria for VIRTUE extended
beyond what is typical for catheter ablation trials and reflected
the range of patients more commonly seen in clinical practice. For
example, of the 125 patients in the VIRTUE trial, only 23% would
have met the criteria for the admIRE trial. Ablation beyond PVI was
performed in 80% of study participants. The VARIPULSE™ Platform was
demonstrated to be able to treat a variety of paroxysmal and
persistent atrial fibrillation patients, as well as those with
atypical atrial flutter, with lesions beyond PVI.2
"Findings from the admIRE study add to our comprehensive PFA
evidence generation strategy and continue to point to the safety
and efficacy of the VARIPULSE™ Platform, and other PFA tools," said
Jennifer Currin, Ph.D., Vice
President, Scientific Affairs, Cardiovascular & Specialty
Solutions, Johnson & Johnson MedTech. "The breadth of data
presented by Biosense Webster at this year's meeting underscores
our commitment advancement of knowledge and innovation in the
treatment of cardiac arrhythmias."
AFib is the most common type of cardiac arrhythmia and affects
more than 8 million people in the United
States and nearly 50 million people worldwide.3
Approximately 1 in 4 adults over the age of 40 are at risk for
developing AFib.4 Despite these projections, about
one-third of patients with AFib are not aware they have the
condition, and AFib often goes unrecognized until the onset of
complications.5,6 Catheter ablation is a safe and
effective procedure when drugs don't work to help restore the
heart's incorrect electrical signals, which cause an abnormal heart
rhythm.7
Additional information on Biosense Webster's data presented at
HRS can be found here.
About the VARIPULSE™ Platform
The VARIPULSE™ Platform is Biosense Webster's Irreversible
Electroporation ablation system. The fully integrated platform
includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3
Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense
Webster announced that the VARIPULSE™ Platform received
its first regulatory approval from the Japan Ministry of Health,
Labour and Welfare for the treatment of symptomatic drug refractory
recurrent PAF using PFA. In Europe, the TRUPULSE™ generator received CE
mark in late 2023 and the VARIPULSE™ Platform received CE mark in
February 2024. In the U.S., the VARIPULSE™ Catheter and
TRUPULSE™ Generator are currently investigational and are not
approved by regulatory authorities. In March
2024, Biosense Webster announced the submission of the
VARIUPLSE™ Platform for Premarket Approval Application to the U.S.
Food & Drug Administration.
About admIRE
The admIRE study (Assessment of Safety and Effectiveness in
Treatment Management of Atrial Fibrillation With the Biosense
Webster IRE Ablation System) (NCT05293639) is a prospective,
multi-center, single-arm study to demonstrate the safety and
long-term effectiveness of the VARIPULSE™ Platform when used for
isolation of pulmonary veins in treatment of patients in
the United States with symptomatic
drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was
achieved using the VARIPULSE™ Platform. The study consisted of a
pilot phase, which assessed initial device safety and
effectiveness, and a pivotal phase, which assessed these against
pre-specified performance goals. The primary safety endpoint was
incidence of early onset (within seven days) primary adverse
events; atrioesophageal fistula (within 90 days); cardiac tamponade
or perforation (within 30 days); and PV stenosis (within 12
months). Acute procedure success (defined as confirmed entrance
block at the end of procedure) and freedom from documented atrial
arrhythmia recurrence at 12 months were also assessed.
About VIRTUE
The VIRTUE study is a collaborative, investigator-sponsored,
prospective, single-center, nonrandomized, interventional clinical
study to evaluate the safety and efficacy of using the Biosense
Webster VARIPULSE™ Platform, inclusive of the VARIPULSE™ Catheter
in combination with the TRPULSE™ Generator, and the compatible EAM
system to treat patients with a variety of atrial arrhythmias
during clinically-indicated ablation procedures. A total of 125
evaluable subjects were enrolled including all types of
AFib-related arrhythmias and were evaluated for 12 months
post-procedure.
About Biosense Webster
Biosense Webster, part of Johnson & Johnson MedTech, leads in
cardiac arrhythmia diagnosis and treatment worldwide. We are
dedicated to advancing electrophysiology and interventional
cardiology tools and solutions for improved patient care.
Learn more at biosensewebster.com and connect on
LinkedIn and X, formerly Twitter.
About Johnson & Johnson MedTechvii
At Johnson & Johnson MedTech,vii we unleash
diverse healthcare expertise, purposeful technology, and a passion
for people to transform the future of medical intervention and
empower everyone to live their best life possible. For more than a
century, we have driven breakthrough scientific innovation to
address unmet needs and reimagine health. In surgery, orthopaedics,
vision, and interventional solutions, we continue to help save
lives and create a future where healthcare solutions are smarter,
less invasive, and more personalized.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
the VARIPULSE™ Platform clinical trials. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of Biosense Webster, Inc.
and/or Johnson & Johnson. Risks and uncertainties include, but
are not limited to: uncertainty of regulatory approvals;
uncertainty of commercial success; challenges to patents;
competition, including technological advances, new products and
patents attained by competitors; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
to applicable laws and regulations, including global health care
reforms; changes in behavior and spending patterns of purchasers of
healthcare products and services; and trends toward healthcare cost
containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online
at sec.gov, jnj.com or on request from Johnson &
Johnson. Neither of Biosense Webster, Inc. nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
i. Primary effectiveness was defined as 12-month
freedom from documented (symptomatic or asymptomatic) atrial
tachyarrhythmia (atrial fibrillation [AF]/atrial tachycardia
[AT]/atrial flutter [AF]) episodes of ≥30 seconds duration based on
rhythm monitoring during the post-blanking evaluation period (day
91-365), as well as freedom from other failure modes: failure to
achieve entrance block in all PVs; >1 repeat ablation for atrial
tachyarrhythmia during the 3-month blanking period or any repeat
ablation during the evaluation period; use of a nonstudy catheter
to treat the PVs and/or to ablate left atrial non-PV AF targets
during the index procedure or to perform a repeat procedure during
the 3-month blanking period; taking new or previously failed Class
I/III AADs at greater doses during the evaluation period;
continuous AF/AT/AFL of unknown origin during the evaluation
period; or direct-current cardioversion during the evaluation
period for AF/AT/AFL recurrences. The protocol defined performance
goal is 50%.
ii. Peak primary effectiveness was defined in a post-hoc
analysis as receiving 73-96 applications for PVI (n=85).
iii. Primary adverse events were defined as:
Device- or procedure- related death, major vascular access
complications or bleeding, myocardial infarction, pericarditis,
heart block, permanent phrenic nerve paralysis, stroke,
thromboembolism, transient ischemic attack, pulmonary edema, and
vagal nerve injury/gastroparesis within 7 days of the index
ablation. PAEs also included cardiac tamponade/perforation
occurring up to 30 days postprocedure, atrioesophageal fistula
occurring up to 90 days post-procedure, and PV stenosis occurring
anytime during the 12-month follow-up period. The protocol-defined
performance goal is 12%.
iv. Acute procedural success was defined as the percent
of participants with electrical isolation of all PVs with confirmed
entrance block at the end of the procedure (n=255).
v. First pass-isolation was defined as achievement of
entrance block after first encirclement evaluated prior to the
adenosine challenge (979/1004 of targeted veins, n=255).
vi. Dr. Reddy served as a study investigator and as
a consultant for BWI. Dr. Reddy was not compensated for this
authorship contribution.
vii.Johnson & Johnson MedTech comprises the surgery,
orthopedics, vision, and interventional solutions businesses within
Johnson & Johnson's MedTech segment.
© Johnson & Johnson Biosense Webster, Inc. 2024. All rights
reserved. M_US_BWI_THER_370349
1 Reddy VY, Calkins H, Mansour M, et al. Long-term
Safety and Effectiveness After Paroxysmal Atrial Fibrillation
Pulsed Field Ablation From the U.S. Multicenter admIRE Study.
Late-breaker LB-469804-04 presented at: Heart Rhythm Society 2024;
May 17; Boston, MA.
2 Musikantow D, Reddy V. Pulsed Field Ablation to Treat
Atrial Fibrillation and Related Arrhythmias Resembling Usual
Clinical Practice: Initial Results of VIRTUE [abstract]. In: Heart
Rhythm Society Annual Meeting.; May
16-19; Boston.
3 Mensah, G, Fuster, V, Murray, C. et al. Global Burden
of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol.
2023 Dec, 82 (25) 2350–2473.
https://doi.org/10.1016/j.jacc.2023.11.007
4 Staerk, et al. 2018 Lifetime risk of atrial
fibrillation according to optimal, borderline, or elevated levels
of risk factors: cohort study based on longitudinal data from the
Framingham Heart Study. doi: 10.1136_bmj.k1453 | BMJ
2018;361:k1453
5 Dilaveris PE, Kennedy HL. Silent atrial fibrillation:
epidemiology, diagnosis, and clinical impact. Clin Cardiol.
2017;40:413–418.
6 Benjamin EJ, Go AS, Desvigne-Nickens P et al. Research
Priorities in Atrial Fibrillation Screening: A Report From a
National Heart, Lung, and Blood Institute Virtual Workshop.
Circulation. 2021;143:372–388.
7 Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF
catheter ablation with a contact force sensing catheter: results of
the prospective, multicenter SMART-AF trial. Journal of the
American College of Cardiology, 2014;64(7),647–656. doi:
10.1016/j.jacc.2014.04.072
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