LivaNova Provides Update on RECOVER Clinical Study Evaluating VNS Therapy for Treatment-Resistant Depression in Unipolar Patients
06 6월 2024 - 10:00PM
Business Wire
Primary endpoint did not achieve statistical
significance in unipolar patient cohort
Statistically significant and clinically
meaningful benefits seen in select secondary endpoints; no safety
concerns identified
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology
company, today announced the preliminary results for the unipolar
patient cohort of the RECOVER clinical study, assessing the use of
VNS Therapy™ in treatment-resistant depression. The study did not
meet its primary endpoint (PE) for the unipolar cohort; however,
statistical significance was achieved in select secondary
endpoints.
The PE measured the difference between active and sham VNS
Therapy on the rate of Montgomery–Åsberg Depression Rating Scale
(MADRS) response for the unipolar patient cohort with a
predetermined p-value of p<0.023. Over the course of 12 months,
the active treatment arm demonstrated statistically significant and
clinically meaningful improvement from the treatment arm’s
baseline. Due to a strong response in the sham group, which was
unforeseen in the study design, statistical separation between the
treatment and sham arms for the PE was not achieved by the end of
the study. Despite this, the totality of data supports a meaningful
treatment effect for those who received active VNS Therapy
particularly given that the RECOVER unipolar patient population has
a significant unmet need after having failed numerous other
treatment modalities.
“We would like to thank the patients and physicians who
participated in RECOVER to date, as well as the U.S. Centers for
Medicare and Medicaid Services, who we partnered with to design
this study,” said Vladimir Makatsaria, Chief Executive Officer of
LivaNova. “Despite not achieving statistical significance for the
primary endpoint for the unipolar cohort in the RECOVER study, the
effect of active VNS Therapy was within our expectations and
resulted in clinically meaningful benefits in select secondary
endpoints. We are conducting an in-depth analysis of the data with
key stakeholders and will determine the path forward in the coming
weeks."
The Company expects to publish the unipolar cohort data,
including details on the PE and secondary endpoints, in
peer-reviewed journals in the fourth quarter of 2024. Importantly,
no safety issues were reported.
“I am encouraged by the clinically meaningful outcomes for the
RECOVER unipolar patient population that is markedly treatment
resistant,” said Dr. Charles R. Conway, Director of the Washington
University in St. Louis Resistant Mood Disorders Center and
Principal Investigator for RECOVER. “As we have previously
published, the unipolar patients who entered the RECOVER study were
of a greater severity than we had anticipated in the study design
and have very few treatment options remaining. We now have a large
body of data to evaluate, and I look forward to better
understanding it in totality.”
The bipolar patient cohort continues for RECOVER and LivaNova
will continue its discussions with the U.S. Centers for Medicare
and Medicaid Services (CMS) regarding reconsideration of coverage
for VNS Therapy for treatment-resistant depression.
About RECOVER
LivaNova’s VNS Therapy 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 – which 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 – is a clinical study
initiated in September 2019 as part of a Coverage with Evidence
Development framework per the U.S. Centers for Medicare and
Medicaid (CMS) National Coverage Determination process.
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. For more information on
the RECOVER clinical study, please visit www.RECOVERVNS.com.
About VNS Therapy for Depression
The VNS Therapy™ System, Symmetry™, is FDA 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. Commonly reported side effects are hoarseness,
shortness of breath, sore throat and coughing. Side effects
typically occur during stimulation and are less noticeable over
time. Safety information is available here.
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 progress
relating to 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 Zachary Glazier Manager, Investor
Relations InvestorRelations@livanova.com Deanna Wilke VP,
Corporate Communications Corporate.Communications@livanova.com
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