Results presented virtually via Heart Rhythm
365 Platform; study met primary effectiveness endpoint of
superiority in favor of the hybrid Convergent procedure
AtriCure, Inc. (Nasdaq: ATRC), a leading
innovator in treatments for atrial fibrillation (Afib) and left
atrial appendage (LAA) management, today announced the results from
the CONVERGE IDE clinical trial. This first-of-its-kind trial,
designed to demonstrate superiority, showed an 18% difference in
favor of the hybrid Convergent procedure as compared to endocardial
catheter ablation alone. The results of the trial were presented as
part of the late-breaking clinical trials at the Heart Rhythm
Society’s (HRS) Annual Scientific Session and were broadcasted
virtually via the Heart Rhythm 365 digital platform.
“The CONVERGE study is a monumental step forward in the market
focused on the most difficult to treat Afib patients, those with
persistent or long-standing persistent forms of the disease,” said
Michael Carrel, President and Chief Executive Officer at AtriCure.
“This patient population represents many millions of patients and
more than two-thirds of all diagnosed Afib patients. The study
results presented at HRS mark a major milestone for the CONVERGE
study and we look forward to working with the FDA moving
forward.”
The CONVERGE IDE trial’s primary effectiveness endpoint is
freedom from Afib, atrial tachycardia (AT), and atrial flutter
(AFL), absent class I and III anti-arrhythmic drugs (AADs) except
for a previously failed or demonstrated intolerance to class I or
III AADs, with no increase in dosage following the 3-month blanking
period through the 12-months post procedure follow-up visit. The
primary safety endpoint is the incidence of protocol-defined major
adverse events (MAEs) for subjects undergoing the Convergent
procedure from the time of the intervention through 30-days post
intervention. There were no deaths, cardiac perforations or
atrio-esophageal fistulas reported in the trial. Dr. DeLurgio
presented the MAE rate of 7.8% in treatment arm, which was lower
than the protocol pre-specified performance goal of 12%. There were
also no long-lasting safety events observed in the trial. More
detail can be found in Table 1 below.
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
Convergent procedure or an endocardial catheter ablation alone. Dr.
David DeLurgio, MD, of Emory St. Joseph’s Hospital in Atlanta,
Georgia, was the trial’s national principal investigator.
“This is one of the most highly anticipated trials in the Afib
space in many years because of the potential to effectively treat
patients who are difficult to treat. I’m very pleased about the
results of the trial, which showed an 18% difference between the
Convergent arm and the control arm in evaluable patients at 12
months,” said Dr. DeLurgio. “Additionally, the measure of Afib
burden reduction of greater than 90% was remarkable and much better
than expected. The data presented showed a greater than 23%
advantage for the Convergent arm over the control arm. Based on
these findings, epicardial and endocardial ablation using the
hybrid Convergent procedure could prove to be a preferred therapy
for patients with advanced forms of Afib.”
Afib affects over 33 million people worldwide and approximately
70% have persistent and longstanding persistent Afib.1 Afib
increases the risk of stroke and is linked with increased risk of
mortality.
“Most importantly, in keeping with the AtriCure mission, we look
forward to working interactively with the FDA towards the approval
of the therapy, which will facilitate targeted training and a more
informed physician-patient discussion,” said Mr. Carrel.
Table 1: Effectiveness
endpoints Note: FDA is currently reviewing the results of the
CONVERGE IDE Trial
Parameter
Convergent ablation
arm
Endocardial catheter ablation
arm
Difference (Convergent –
Control)
p-value
Freedom from AFib/AFL/AT from 3-month
blanking period through the 12-months* without imputation of
missing data as failure n%, (95% Confidence Interval)
67.7% (67/99) (58.5%-76.9%)
50.0% (25/50) (36.1%- 63.9%)
17.7% in favor of Convergent
0.036
Freedom from AFib/AFL/AT from 3-month
blanking period through the 12-months* with imputation of missing
data as failure n%, (95% Confidence Interval)
65.7% (67/102) (56.5%- 74.9%)
49.0% (25/51) (35.3% – 62.7%)
16.7% in favor of Convergent
0.047
>90%
burden reduction at 12 months* n%, (95% Confidence Interval)
80% (60/75) (70.9% – 89.1%)
56.8% (25/44) (42.2% – 71.5%)
23.2% in favor of Convergent
0.007
Freedom from AF through 12 months * n%,
(95% Confidence Interval)
71% (72/102) (61.7% – 79.4%)
51% (26/51) (37.3% – 64.7%)
20.0% in favor of Convergent
0.017
*Without new/ increased dosage of
previously failed class I/III AADs AADs: anti-arrhythmic drugs; AF:
atrial fibrillation; AFL: atrial flutter; AT: atrial
tachycardia
The EPi-Sense device and hybrid procedure are investigational
and not approved in the US for the treatment of Afib. The data
analyses presented have not been reviewed by FDA.
Virtual Broadcast from Heart Rhythm 365 and Conference Call
to Discuss Trial Results
The results were broadcast on the Heart Rhythm 365 digital
platform. AtriCure will host a virtual meeting at HRS at 1:00 p.m.
Eastern U.S. time to discuss the results from the trial. A live
audio and slide presentation webcast of the meeting may be accessed
by visiting the Investors page of AtriCure’s corporate website at
ir.atricure.com. The live audio only feed of the call may be access
through an operator by calling 844-884-9951 for domestic callers
and 661-378-9661 for international callers using conference ID
number 1978277. A replay of the presentation will be available on
the website following the meeting.
About the CONVERGE IDE Trial
The CONVERGE IDE trial is a landmark prospective, superiority,
randomized controlled pivotal trial to evaluate the overall success
of the hybrid Convergent ablation to endocardial catheter ablation
for patients with persistent or long-standing persistent Afib. The
procedure combines a minimally invasive, closed chest epicardial
ablation performed by a surgeon with endocardial catheter ablation
performed by an electrophysiologist.
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 and only
medical device to receive FDA approval for the treatment of
persistent Afib. AtriCure’s AtriClip Left Atrial Appendage (LAA)
Exclusion System products are the most widely sold LAA management
devices worldwide. 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
such as “intends," “estimates,” “anticipates,” “hopes,” “projects,”
“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, 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 implement its commercialization plans for CONVERGE, if
approved; whether the market opportunity for CONVERGE is consistent
with the Company’s expectations and market research; whether any
additional clinical trials will be initiated or required for
CONVERGE prior to approval of FDA, or at all, and whether CONVERGE
will be approved by FDA and any other required regulatory
authorities; AtriCure’s ability execute on the commercial launch of
CONVERGE, if and when approved, on the timeline expected, or at
all; whether AtriCure will be able to generate its projected net
product revenue on the timeline expected, or at all; whether
AtriCure’s cash resources will be sufficient to fund AtriCure’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements for AtriCure’s expected timeline; other
matters that could affect the availability or commercial potential
of CONVERGE and AtriCure’s product candidates, including CONVERGE;
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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Andy Wade Investor Relations Chief Financial Officer (513)
755-4564 awade@AtriCure.com Valerie Storch-Willhaus Media Relations
Senior Director, Corporate Marketing and Communications (612)
605-3311 vstorch-willhaus@AtriCure.com
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