Japan approves Inspire Medical ’ s obstructive sleep apnea neurostim device

Inspire Medical Systems said this week it won approval from Japan’s Ministry of Health, Labour and Welfare for its Inspire therapy system, now cleared to treat moderate to severe obstructive sleep apnea. The Inspire system is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea. Inspire Medical Systems said that it will pursue reimbursement in the country, with plans to launch the device in the second half of next year. “With this approval for our Inspire therapy, we are able to provide patients and physicians in Japan with a new alternative for the treatment of moderate to severe OSA. Our Inspire therapy is supported by a strong body of evidence with more than five years of clinical experience demonstrating the efficacy and safety of our therapy for patients and physicians. We look forward to commercializing our Inspire therapy in Japan. We would like to thank Cobridge Co., Ltd., a leading regulatory affairs consulting firm that provides comprehensive product registration services for medical products in Japan, for their outstanding efforts and expertise in assisting us to gain approval in Japan,” prez &CEO Tim Herbert said in a press release. Last month, Inspire Medical Systems up-sized its initial public offering to $108 million, or some $124 million if the underwriters option is exercised in full. The post Japan approves Inspire Medical’s obstructive sleep apnea neu...
Source: Mass Device - Category: Medical Devices Authors: Tags: Neuromodulation/Neurostimulation Regulatory/Compliance Respiratory Inspire Medical Systems Inc. Source Type: news

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In this study, it was aimed to analyze the relationship between the severity of OSAS and vitamin-D levels among the participants whose features affecting serum vit-D levels were minimised. Serum 25-OH vitamin-D levels in 121 OSAS Male patients diagnosed by polysomnography without any systemic disease or vitamin-D supplement that may effect the vitamin-D metabolism were measured. The study was conducted in winter (latitude: 41°). Anthropometric measures and biochemical tests were also performed. The distribution of vitamin-D levels was determined as severe deficiency, deficiency, insufficiency and sufficiency. Apne...
Source: International Journal for Vitamin and Nutrition Research - Category: Nutrition Tags: Int J Vitam Nutr Res Source Type: research
Inflammatory cytokines tumor necrosis factor-α, interleukin-8 and sleep monitoring in patients with obstructive sleep apnea syndrome. Exp Ther Med. 2019 Mar;17(3):1766-1770 Authors: Ming H, Tian A, Liu B, Hu Y, Liu C, Chen R, Cheng L Abstract The present study investigated the changes of tumor necrosis factor-α (TNF-α), interleukin-8 (IL-8) and sleep ability in patients with obstructive sleep apnea hypopnea syndrome (OSAHS). A total of 684 patients who were admitted to Xuzhou Central Hospital between June 2012 and June 2016 were enrolled to serve as the experimental group and 192 heal...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
FRIDAY, Feb. 22, 2019 -- Obstructive sleep apnea (OSA) patients with excessive daytime sleepiness are at a substantially increased risk for cardiovascular disease (CVD) compared with individuals with other OSA subtypes, according to a study...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
Authors: Kirac D, Yagcioglu Yassa O, Gezmis H, Mayda Domac SF, Altunok EC, Genc E Abstract Obstructive sleep apnea syndrome (OSAS) is a highly prevalent disorder which results in markedly reduced (hypopnea) or absent (apnea) airflow at the nose/mouth. Since vitamin D deficiency has found in an association with some disorders it is thought to be related with OSAS progression. The aim of this study is to investigate the association between VDR, VDBP mutations, vitamin D level and some environmental risk factors with OSAS. Fifty individuals who were diagnosed as OSAS were selected as patients, 50 healthy volunteers wi...
Source: Cellular and Molecular Biology - Category: Molecular Biology Tags: Cell Mol Biol (Noisy-le-grand) Source Type: research
Since reports on surgical results for pediatric obstructive sleep apnea (OSA) in Japan are insufficient for debate, this study aimed to evaluate the feature of Japanese OSA children and surgical result and document whether is obesity and affecting factor similar to non-Asian countries.
Source: Auris, Nasus, Larynx - Category: ENT & OMF Authors: Source Type: research
Conditions:   Sleep Apnea Syndromes, Obstructive;   Dizziness;   Eustachian Tube Dysfunction Intervention:   Sponsor:   Tel-Aviv Sourasky Medical Center Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Obstructive Sleep Apnea Intervention:   Sponsors:   University Health Network, Toronto;   Canadian Lung Association Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Sleep Apnea Syndromes, Obstructive;   Dizziness;   Eustachian Tube Dysfunction Intervention:   Sponsor:   Tel-Aviv Sourasky Medical Center Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Obstructive Sleep Apnea Intervention:   Sponsors:   University Health Network, Toronto;   Canadian Lung Association Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Sleep Apnea Syndromes, Obstructive;   Dizziness;   Eustachian Tube Dysfunction Intervention:   Sponsor:   Tel-Aviv Sourasky Medical Center Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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