Results published in two articles in Brain
Stimulation
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology
company, today announced that the journal Brain Stimulation has
published two pivotal articles chronicling the unipolar cohort data
set for the RECOVER clinical study. The researchers evaluated the
safety and efficacy of LivaNova’s VNS Therapy™ System and its
effectiveness on quality of life and daily function in this
population of patients with treatment-resistant unipolar
depression. Overall, the articles concluded that active VNS
Therapy, as compared with a no-stimulation control (or sham VNS
Therapy), safely and effectively demonstrated clinically meaningful
therapeutic effects on depressive symptoms and positive effects on
quality of life and daily function. These findings support the use
of VNS Therapy to deliver vagus nerve stimulation (VNS) in
treatment-resistant depression (TRD) patients.
A total of 493 adults with at least four documented unsuccessful
attempts with antidepressant treatments participated in the
unipolar cohort of the RECOVER study. At baseline, unipolar
patients in the study failed more than 13 antidepressant treatments
(on average) – this included, for the majority, one or more
interventional therapies (e.g., transcranial magnetic stimulation,
electroconvulsive therapy, or esketamine). While the RECOVER study
did not meet the primary endpoint due to a strong and unforeseen
response in the sham group, the active treatment arm demonstrated
statistically significant and clinically meaningful improvement
from the treatment arm’s baseline. Further, the RECOVER study
demonstrated statistically significant and clinically meaningful
benefits in select secondary endpoints for this cohort. Based upon
these findings and the positive effects for those who received VNS
Therapy, the Company conducted additional in-depth data analyses
and plans to submit three additional critical manuscripts to report
on the outcomes.
“Participants in the trial had severe, refractory depression
that could not be treated effectively with other FDA-approved
treatments, and most have had large portions of their lives
profoundly negatively impacted by depression,” said Charles Conway,
MD, director of the Washington University Resistant Mood Disorders
Center at Washington University School of Medicine in St. Louis.
Conway is the study's lead investigator and first author of the
mood outcomes article. “For this sample of markedly ill TRD
participants, I am encouraged by the findings, which revealed that
active VNS performed better than sham VNS treatment in all
measures, and that active VNS demonstrated clinically meaningful,
safe therapeutic effects. Multiple clinician, patient, and
independent observer ratings separated between the active and sham
unipolar arms.”
The first article, “Vagus
Nerve Stimulation in Treatment-Resistant Depression: A One-Year,
Randomized, Sham-Controlled Trial,”1 outlines the safety and
effectiveness of adjunctive VNS Therapy in treating patients with
unipolar TRD. The primary endpoint measured the difference in the
percentage of time in antidepressant response between active VNS
Therapy and sham VNS Therapy, with response defined as at least a
50% reduction from baseline using the Montgomery-Åsberg Depression
Rating Scale (MADRS) total score. While the predetermined p-value
was p<0.023, the observed mean percentage of time in response
was p=0.137.
Analyses of secondary endpoints revealed antidepressant benefits
significantly favoring active VNS Therapy as opposed to sham VNS
Therapy as measured by ratings from on-site clinicians (Clinical
Global Impression-Improvement, or CGI-I), patients themselves
(Quick Inventory of Depressive Symptomology–Self Report, or
QIDS-SR), and offsite masked raters (Quick Inventory of Depressive
Symptomology–Clinical, or QIDS-C).
Results included:
- Participants with active VNS Therapy had
significantly more percentage of time in response with CGI-I
(P=0.004) and QIDS-SR (P=0.049) compared with sham VNS
Therapy.
- For percentage of time in partial response,
active VNS Therapy showed significant benefit with QIDS-C (P=0.006)
and CGI-I (P<0.001) compared with sham VNS Therapy. Partial
response is defined as improvement of ≥30% from baseline for QIDS-C
or a score of ≤3 for CGI-I.
- No differences between treatment groups were
observed in suicidal ideation and intent as measured by the S-STS2
items 6 and 8 (P=0.239).
“The composite of the mood findings, especially in the partial
response rates on multiple ratings scales, along with the low rate
of adverse events, support that this device demonstrated safe
antidepressant efficacy for these patients,” said Conway.
The second article, “Effects
of Vagus Nerve Stimulation on Daily Function and Quality of Life in
Markedly Treatment-Resistant Major Depression: Findings from a
One-Year, Randomized, Sham-Controlled Trial,”3 assesses VNS
Therapy’s ability to improve quality of life (QoL) and daily
function in patients with unipolar TRD. The results of this
analysis demonstrated that adjunctive VNS Therapy provided greater
improvements in QoL and daily function in patients with unipolar
TRD when compared with sham VNS Therapy.
Results included:
- The active VNS Therapy group showed greater
improvements over the sham control group as measured by the mean
change in scores from baseline in the Mini-Q-LES-Q4 (P=0.050) and
WPAI5 item 6 (health condition’s effect on regular activities;
P=0.050) used as continuous variables.
- Time spent in a state of clinically meaningful
benefit was significantly greater with active VNS Therapy compared
to sham VNS Therapy, using the Q-LES-Q6 (P=0.029), Mini-Q-LES-Q
(P=0.011) and WPAI item 6 (P=0.039).
- No differences between treatment groups were
observed in the mean change in score from baseline with the WHODAS7
2.0 (P=0.304) and the EQ-5D8 visual analog scale (P=0.125).
“Adjunctive VNS Therapy improves quality of life and
psychosocial function in patients with major depression who have
not benefited from multiple antidepressant treatments,” said A.
John Rush, MD, Professor Emeritus at Duke-National University of
Singapore Medical School and lead author on this article. “For
these patients who are profoundly impaired, largely unemployed, and
markedly treatment-resistant, depressive symptoms alone are an
incomplete gauge of the clinical impact of treatments. Symptoms,
function, and quality of life taken together present a more
complete picture of treatment effectiveness.”
These two articles published in Brain Stimulation are the first
in a series that will detail the RECOVER unipolar cohort data.
Three subsequent, supportive
manuscripts will feature outcomes from in-depth data
analyses on select secondary endpoints. The totality of data
presented in these five complementary articles will serve as the
basis for LivaNova’s formal request to the U.S. Centers for
Medicare and Medicaid Services (CMS) for VNS Therapy coverage.
“Patients in the RECOVER study are some of the most critically
ill among those with treatment-resistant depression and they need
more treatment options when existing therapies fail,” said Vladimir
Makatsaria, Chief Executive Officer of LivaNova. “The data from the
RECOVER study and predecessor studies has shown that VNS Therapy is
a safe and effective treatment option for these patients, providing
hope for patients and families in similar situations who have few
viable options. We look forward to sharing more of the important
outcomes from the unipolar cohort with the intent to offer VNS
Therapy as an important adjunctive treatment for these
patients.”
RECOVER launched in 2019 as part of a Coverage with Evidence
Development framework per the CMS National Coverage Determination
process. For the unipolar cohort of RECOVER, enrollment was
completed in March 2023, and the 12-month follow-up for those
patients was completed in March 2024. No new safety issues were
identified in the study.
About RECOVER
LivaNova’s VNS Therapy™ System has been approved for the
treatment of depression since earning CE Mark in 2001 and 510(k)
from the U.S. Food and Drug Administration in 2005. RECOVER stands
for A Prospective, Multi-center, Randomized
Controlled Blinded Trial Demonstrating the Safety and
Effectiveness of VNS Therapy System as Adjunctive
Therapy Versus a No Stimulation Control in Subjects With
Treatment-Resistant Depression.
The largest randomized clinical study of its kind, RECOVER is
examining up to 1,000 patients ages 18 or older who have unipolar
or bipolar depression that is difficult to treat. The double-blind,
randomized controlled study is assessing how VNS Therapy can offer
patients relief from their depressive symptoms and improve quality
of life. It is being carried out at up to 100 leading hospitals and
medical centers across the United States.
About VNS Therapy for Depression
The VNS Therapy™ System, Symmetry™, is U.S. Food and Drug
Administration-approved and indicated in the U.S. for the
adjunctive long-term treatment of chronic or recurrent depression
for patients 18 years of age or older who are experiencing a major
depressive episode and have not had an adequate response to four or
more adequate antidepressant treatments The most commonly reported
side effects are voice alteration or hoarseness, prickling or
tingling in the skin, increased coughing, shortness of breath, and
sore throat. Infection is the most common complication of the
surgical procedure. Important safety information is available at
www.livanova.com/depression/en-us/safety-information.
References
- Conway CR, et al. Vagus nerve stimulation in
treatment-resistant depression: A one-year, randomized,
sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI:
10.1016/j.brs.2024.12.1191.
- The Sheehan Suicidality Tracking Scale (S-STS)
is a clinician-administered rating scale that tracks
treatment-emergent suicidal ideation and behaviors.
- Rush AJ, et al. Effects of vagus nerve
stimulation on daily function and quality of life in markedly
treatment-resistant major depression: Findings from a one-year,
randomized, sham-controlled trial. Brain Stimulation. Dec. 18,
2024. DOI: 10.1016/j.brs.2024.12.1187.
- Mini-Q-LES-Q (Quality of Life Enjoyment and
Satisfaction Questionnaire – Short Form) is a quality-of-life
measure from a self-report assessing the patient’s degree of
enjoyment and satisfaction across seven domains as a subset of the
Q-LES-Q.
- WPAI item 6 is a function measure from the
Work Productivity and Activity Impairment (WPAI)
Questionnaire.
- Q-LES-Q is a quality-of-life measure from a
self-report assessing the patient’s degree of enjoyment and
satisfaction experienced over the previous seven days across 14
domains.
- WHODAS (World Health Organization Disability
Assessment Schedule) assesses the patient’s ability to perform
activities in the previous month in six domains.
- The EuroQoL Five-Dimension Questionnaire
(EQ-5D) is a generic QoL measure that assesses mobility, self-care,
usual activities, pain/discomfort, and anxiety/depression.
About LivaNova
LivaNova PLC is a global medical technology company built on
nearly five decades of experience and a relentless commitment to
provide hope for patients and their families through medical
technologies, delivering life-changing solutions in select
neurological and cardiac conditions. Headquartered in London,
LivaNova employs approximately 2,900 employees and has a presence
in more than 100 countries for the benefit of patients, healthcare
professionals, and healthcare systems worldwide. For more
information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains “forward-looking statements”
concerning the Company’s goals, beliefs, expectations, strategies,
objectives, plans, underlying assumptions, and other statements
that are not necessarily based on historical facts. These
statements include, but are not limited to, statements regarding
the RECOVER study and the VNS Therapy™ System, Symmetry™. Actual
events may differ materially from those indicated in our
forward-looking statements as a result of various factors,
including those factors set forth in Item 1A of the Company’s most
recent Annual Report on Form 10-K, as supplemented by any risk
factors contained in Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K. LivaNova undertakes no obligation to update
the information contained in this press release to reflect
subsequently occurring events or circumstances.
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LivaNova Investor Relations and Media Contacts +1
281-895-2382 Briana Gotlin VP, Investor Relations
InvestorRelations@livanova.com Deanna Wilke VP, Corporate
Communications Corporate.Communications@livanova.com
LivaNova (NASDAQ:LIVN)
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