LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today commented on the U.S. Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo regarding its National Coverage Determination (NCD) for the LivaNova Vagus Nerve Stimulation Therapy® (VNS Therapy) System for Treatment-Resistant Depression (TRD).
Within the Proposed Decision Memo, CMS proposes to change the NCD for VNS Therapy for TRD to expand Medicare coverage. CMS could initiate coverage for Medicare beneficiaries through Coverage with Evidence Development (CED) when offered in a CMS-approved, double-blind, randomized, placebo-controlled trial with a follow-up duration of at least one year, with the possibility of extending the study to a prospective longitudinal study.
LivaNova intends to commence a clinical study that meets these requirements, once the NCD decision is finalized by CMS on or before Feb. 17, 2019.
LivaNova remains committed to providing additional treatment options for patients with depression and finds the Proposed Decision Memo from CMS to be a positive step toward increased access to important therapies for these patients. Over the last decade, a significant body of new evidence has emerged showing that the addition of VNS Therapy is effective in reducing symptoms in patients with chronic or recurrent depression.
With the release of its Proposed Decision Memo, CMS opened a 30-day public comment period. LivaNova encourages interested parties to comment on the proposed decision memo by Dec. 19, 2018 to be considered by CMS. All relevant information related to this process is available on the CMS website.
LivaNova looks forward to the final decision from CMS regarding Medicare coverage of VNS Therapy for TRD. This would be a positive outcome for patients and physicians.
Conference Call Instructions
The Company will host a conference call for interested parties commencing at 2 p.m. London time (9 a.m. Eastern Standard Time) on Tuesday, Nov. 20, 2018. To listen to the conference call, dial (844) 601-5111 (if dialing from within the U.S.) or (647) 253-8650 (if dialing from outside the U.S.). The conference ID is 7786437.
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.
Safe Harbor Statement
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All information in this news release is as of the date of its release. LivaNova does not undertake or assume any obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this news release.