FDA approval results in the only label of its
kind for more than 3 million patients in the United States,
significantly expanding AtriCure’s addressable market
Superiority trial showed a 29% difference in
effectiveness at 12 months and a 35% difference in effectiveness at
18 months for long-standing persistent Afib patients.
Study also showed improved Electrophysiology
Lab efficiency
AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments
for atrial fibrillation (Afib) and left atrial appendage (LAA)
management, today announced U.S. Food and Drug Administration (FDA)
approval of the EPi-Sense® System to treat patients diagnosed with
long-standing persistent Afib. The CONVERGE™ trial demonstrated
superiority in the hybrid AF™ therapy arm compared to endocardial
catheter ablation alone. In patients diagnosed with long-standing
persistent Afib, the hybrid therapy arm showed a 29% absolute
difference in efficacy at 12-months (78% relative improvement) and
an absolute difference of 35% at 18 months (110% relative
improvement). There was also a 33% absolute difference in Afib
burden reduction in favor of the hybrid AF therapy at 12 months,
which increased to 37% at 18 months.
“FDA approval is a monumental step forward in the market focused
on patients with the most advanced and difficult to treat Afib,”
said Michael Carrel, President and Chief Executive Officer at
AtriCure. “The long-standing persistent Afib population represents
over three million patients in the United States alone, or nearly
half of all diagnosed Afib patients. This approval will enable us
to educate and train physicians across the country on the benefits
of hybrid AF therapy in treating long-standing persistent Afib
patients. In addition to superior clinical results, the procedure
significantly improves electrophysiology lab efficiency by reducing
endocardial ablation times by over 40 minutes, improving throughput
and enabling more patients to be treated.”
“This therapy should help change the standard of care and
improve the lives of millions of patients. Due to less than optimal
outcomes with endocardial ablation alone, many patients in whom
Afib has progressed are not even considered for ablation treatment
today. The high-quality evidence from the CONVERGE trial should
encourage cardiologists, electrophysiologists and surgeons, as a
team, to consider this procedure for these patients,” said David
DeLurgio, M.D., Director of Electrophysiology at Emory St. Joseph’s
Hospital, and the trial’s global principal investigator. “The
improvement using the EPi-Sense System for posterior left atrial
wall and pulmonary vein ablation, in combination with an
endocardial catheter to address lesion gaps, is truly remarkable.
Additionally, Afib burden reduction results are especially
encouraging as they mirror our experience as well as peer reviewed
published data outside of the trial.”
Afib affects over 33 million people worldwide and approximately
45% of those people have long-standing persistent Afib.1 Afib
increases the risk of stroke and is linked with increased risk of
mortality. The number of people with Afib is expected to increase
significantly over the next decade.
“Hybrid AF therapy is the only FDA-approved minimally invasive
ablation procedure to treat patients who have been in continuous
Afib for more than one year, which is a large number of my
patients,” said Hugh Calkins, M.D., Director of the Arrhythmia
Service and the Clinical Electrophysiology Lab at Johns Hopkins
University. “These patients with advanced Afib are very difficult
to treat with catheter ablation alone. The data from the CONVERGE
trial is compelling, and patients will benefit greatly from having
this treatment.”
18-Month Data Shows Durability
Data from the CONVERGE trial at 18 months has shown that hybrid
AF therapy provides durable, sustained efficacy. In the treatment
arm, freedom from all arrhythmias in the long-standing persistent
population was 61%, versus 26% for endocardial catheter ablation
alone. Freedom from Afib alone at 18-months was 68% for hybrid AF
therapy, versus 30% in the catheter ablation arm for the same group
of patients.
“These 18-month results are incredible and demonstrate the
durability of the procedure,” said Dr. DeLurgio. “This is a key
finding from the trial and shows that patients who undergo a hybrid
procedure should expect continued freedom from Afib. I’m really
looking forward to seeing this therapy expand and impact more
patients who have no other effective treatment options.”
Table 1: Effectiveness
endpoints for long-standing persistent AF sub-group (12-month
follow up)
Parameter
Hybrid ablation arm
(N=38)
Endocardial catheter ablation
arm
(N=27)
Difference
(Hybrid – Endocardial catheter
ablation)
Freedom from AF/AFL/AT from 3-month
blanking period through the 12-months*
n%, (95% Confidence Interval)
65.8%
(50.7%, 80.9%)
37.0%
(18.8%, 55.3%)
28.8%
in favor of Hybrid
>90% AF
burden reduction at 12 months*
n%, (95% Confidence Interval)
78.9%
(66.0%, 91.9%)
46.2%
(27.0%, 65.3%)
32.7%
in favor of Hybrid
Freedom from AF through 12 months *
n%, (95% Confidence Interval)
71.1%
(56.6%, 85.5%)
37.0%
(18.8%, 55.3%)
34.1%
in favor of Hybrid
*Without new/ increased dosage of
previously failed class I/III AADs
AADs: anti-arrhythmic drugs; AF: atrial
fibrillation; AFL: atrial flutter; AT: atrial tachycardia.
Table 2: Effectiveness
endpoints for long-standing persistent AF sub-group (18-month
follow up)
Parameter
Hybrid ablation arm
(N=38)
Endocardial catheter ablation
arm
(N=27)
Difference
(Hybrid – Endocardial catheter
ablation)
Freedom from AF/AFL/AT from 3-month
blanking period through the 18-months*
n%, (95% Confidence Interval)
60.5%
(45.0%, 76.1%)
25.9%
(9.4%, 42.5%)
34.6%
in favor of Hybrid
>90% AF
burden reduction at 18 months*
n%, (95% Confidence Interval)
73.0%
(58.7%, 87.3%)
36.0%
(17.2%, 54.8%)
37.0%
in favor of Hybrid
Freedom from AF through 18 months *
n%, (95% Confidence Interval)
68.4%
(53.6%, 83.2%)
29.6%
(12.4%, 46.9%)
38.8%
in favor of Hybrid
*Without new/ increased dosage of
previously failed class I/III anti-arrhythmic drugs
AF: atrial fibrillation; AFL: atrial flutter; AT: atrial tachycardi
About the CONVERGE Trial
The CONVERGE trial was a landmark prospective, superiority,
randomized controlled pivotal trial to evaluate the overall success
of hybrid ablation compared to endocardial catheter ablation alone
for patients with persistent or long-standing persistent Afib. The
procedure combines a minimally invasive, closed chest epicardial
ablation performed by a surgeon using the AtriCure EPi-Sense System
with endocardial radiofrequency catheter ablation performed by an
electrophysiologist. The trial enrolled 153 patients at 27
locations (25 in the United States and 2 in the United Kingdom).
Patients were randomized at a rate of 2:1 and received either the
hybrid procedure or an endocardial catheter ablation alone.
About AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the
treatment of Afib and related conditions. Afib affects more than 33
million people worldwide. Electrophysiologists and cardiothoracic
surgeons around the globe use AtriCure technologies for the
treatment of Afib and reduction of Afib related complications.
AtriCure’s Isolator® Synergy™ Ablation System is the first medical
device to receive FDA approval for the treatment of persistent
Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System
products are the most widely sold LAA management devices worldwide.
AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure
that provides a lasting solution for long-standing persistent Afib
patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for
temporary ablation of peripheral nerves to block pain, providing
pain relief in cardiac and thoracic procedures. For more
information, visit AtriCure.com or follow us on Twitter
@AtriCure.
Forward-Looking Statements
This press release contains “forward-looking statements,” which
are statements related to future events that by their nature
address matters that are uncertain. All forward-looking information is
inherently uncertain and actual results may differ materially from
assumptions, estimates or expectations reflected or
contained in the forward-looking statements as a result of various
factors. For details on the uncertainties that may cause our actual
results to be materially different than those expressed in our
forward-looking statements, see our Annual Report on Form 10-K and
Quarterly Reports on Form 10- Q
filed with the SEC and available at http://www.sec.gov, which
contain risk factors. Forward-looking statements address our
expected future business, financial performance, financial
condition as well as results of operations, and often contain words
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“plans,” “expects,” “seek,” “believes,” “see,” “should,” “will,”
“would,” “could,” “target,” “guidance,” “forecast,” “goal,”
“objective,” “aim,” and similar expressions and the negative
versions thereof. Such statements are based only upon current
expectations of AtriCure. Any forward-looking statement speaks only
as of the date made. Reliance should not be placed on
forward-looking statements because they involve known and unknown
risks, uncertainties and other
factors which may cause actual results, performance or achievements
to differ materially from those expressed or implied.
Forward-looking statements include statements that address
activities, events or developments that AtriCure expects, believes
or anticipates will or may occur in the future, including, without
limitation, statements about AtriCure's anticipated future
operating and financial performance, business plans, clinical
trials, and prospects and expectations for our product pipeline.
Forward-looking statements are based on AtriCure's experience and
perception of current conditions,
trends, expected future developments and other factors it believes
are appropriate under the circumstances and are subject to
numerous substantial risks and uncertainties, many of which
are beyond AtriCure's control. These risks and uncertainties
include, but are not limited to: whether AtriCure will be able to
successfully execute its commercialization plans for or otherwise
expand the development of CONVERGE; whether the market opportunity
for CONVERGE is consistent with the Company’s expectations and
market research; whether AtriCure will be able to generate its
projected net product revenue in the timeline expected, or at all;
whether AtriCure’s cash resources or other financing sources will
be sufficient to fund AtriCure’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements; other
matters that could affect the availability or commercial potential
of CONVERGE and AtriCure’s other product candidates; risks
associated with market acceptance of CONVERGE; costs associated
with defending intellectual property infringement, product
liability and other claims; regulatory developments in the United
States, Europe and other jurisdictions; and other important
factors, including, without limitation, the effects of the
coronavirus COVID-19 pandemic on the market and AtriCure’s
financial condition and results of operations, any of which could
cause AtriCure’s actual results to differ from those contained in
the forward-looking statements or otherwise discussed in AtriCure’s
reports filed with the U.S. Securities and Exchange Commission.
With respect to the forward-looking statements, we claim the
protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. We undertake no obligation to
publicly update or revise any forward-looking statements to reflect
new information or future events or otherwise unless required by
law.
1 Berisso et al. Epidemiology of atrial fibrillation: European
perspective. Clin Epidemiol. 2014; 6: 213–220.
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Angie Wirick Investor Relations Chief Financial Officer (513)
755-5334 awirick@atricure.com
Valerie Storch-Willhaus Media Relations Vice President,
Corporate Marketing and Communications (612) 605-3311
vstorch-willhaus@atricure.com
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