Open AccessTransvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes
Author(s) -
María Rosa Costanzo,
Shahrokh Javaheri,
Piotr Ponikowski,
Olaf Oldenburg,
Ralph Augostini,
Lee R. Goldberg,
Christoph Stellbrink,
Henrik Fox,
Alan R. Schwartz,
Sanjaya Gupta,
Scott McKane,
Timothy E. Meyer,
William T. Abraham
Publication year - 2021
Publication title -
nature and science of sleep
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.715
H-Index - 34
ISSN - 1179-1608
DOI - 10.2147/nss.s300713
Subject(s) - medicine , epworth sleepiness scale , central sleep apnea , apnea , sleep apnea , randomized controlled trial , clinical trial , apnea–hypopnea index , adverse effect , anesthesia , polysomnography , physical therapy , surgery
The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remedē System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant.