LivaNova Recognizes Final Decision from the U.S. Centers for Medicare & Medicaid Services Regarding National Coverage Determination for VNS Therapy for Treatment-Resistant Depression

Company plans to submit clinical study protocol for CMS consideration

LONDON–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24LIVN&src=ctag” target=”_blank”gt;$LIVNlt;/agt;–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company,
today recognized that the U.S. Centers for Medicare & Medicaid Services
(CMS) finalized its National Coverage Determination (NCD) for the
LivaNova Vagus Nerve Stimulation Therapy® (VNS Therapy)
System for Treatment-Resistant Depression (TRD). Per its final decision,
CMS has modified the NCD for VNS Therapy for TRD to include feedback
received during the comment period in a manner that aligns the Coverage
with Evidence Development (CED) framework with current indications and
standard of practice for clinical study design in this disease state.
This final decision initiates coverage for Medicare beneficiaries
through CED when offered in a CMS-approved, double-blind, randomized,
placebo-controlled trial with a follow-up duration of at least one year,
as well as the coverage of VNS Therapy device replacement. The CED also
includes the possibility to extend the study to a prospective
longitudinal study.

“As part of our commitment to improving the lives of patients around the
world, LivaNova requested that CMS formally reconsider coverage for VNS
Therapy for Treatment-Resistant Depression,” said Damien McDonald, Chief
Executive Officer of LivaNova. “We applaud CMS for taking this
considerable step to provide increased access to treatment through
Coverage with Evidence Development. We are pleased that CMS has expanded
the potential beneficiaries of this therapy by including patients with
bipolar disorder, an important and underserved patient population.
Further, CMS expanded its research questions to include response to
treatment, providing a much better gauge of benefit in this very ill
patient population. Overall, this decision will help the large number of
people who suffer from TRD receive access to an affordable, potentially
life-altering treatment option.”

In October 2017, LivaNova submitted a letter to CMS requesting a formal
reconsideration of the NCD for VNS Therapy for TRD. In May 2018, CMS
accepted the request and published a tracking sheet to initiate a
national coverage analysis and opened a public comment period, marking
the first time CMS had opened the NCD in 10 years. In November 2018, CMS
released a Proposed Decision Memo proposing to cover VNS devices that
are approved by the U.S. Food and Drug Administration for TRD through
CED. After another public comment period, CMS issued its Final Decision
Memo today.

“Not only does the science support that VNS for TRD works, but we have
seen first-hand the profound impact it has on the lives of patients,”
said Dr. Charles R. Conway, Director of the Washington University Center
for Advancement of Research in Resistant Mood and Affective Disorders.
“We have implanted more than 80 TRD patients with VNS devices, many of
whom were on Medicare disability and completely incapacitated by their
depressive illness, oftentimes for years or decades. With VNS treatment,
we have seen them go on to lead productive lives, in most cases, the
effects of the treatment are sustained—unlike most antidepressant
treatments in TRD. This treatment is highly effective and significantly
changes, and may even save, lives.”

LivaNova intends to submit a clinical study protocol to CMS for
consideration and to be conducted in accordance with the agency’s NCD.
Dr. Conway will serve as Principal Investigator for the study.
Enrollment will likely begin in third quarter 2019, and could take as
long as 18 months to enroll approximately 500 patients at a minimum of
40 sites.

“Medicare coverage for TRD patients is critical. Depression is the
leading cause of disability in the U.S. Patients with TRD are often
younger than the typical Medicare beneficiary and will likely become
eligible for Medicare as a result of disability, not age,” said Edward
Andrle, General Manager of Neuromodulation at LivaNova. “We believe that
TRD is an area of high unmet medical need and an area where LivaNova can
make a difference and improve the lives of patients.”

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five
decades of experience and a relentless commitment to improve the lives
of patients around the world. LivaNova’s advanced technologies and
breakthrough treatments provide meaningful solutions for the benefit of
patients, healthcare professionals and healthcare systems. Headquartered
in London, LivaNova has a presence in more than 100 countries worldwide.
The Company currently employs approximately 4,000 employees.
LivaNova operates as two businesses: Cardiovascular and Neuromodulation,
with operating headquarters in Mirandola (Italy) and Houston (U.S.),
respectively.

For more information, please visit www.livanova.com.

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Contacts

LivaNova PLC Investor Relations and Media

Melissa Farina, +1 (281) 228-7262
Vice President, Investor
Relations
[email protected]

Deanna Wilke, +1 (281) 727-2764
Director, Corporate
Communications
[email protected]

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