LivaNova Recognizes Final Decision from the U.S. Centers for Medicare & Medicaid Services Regarding National Coverage Determination for VNS Therapy for Treatment-Resistant Depression - Seite 2

“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.