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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Conclusions:Unrecognized severe OSA was common in patients with difficult-to-control hypertension, and OSA severity was associated with myocardial injury, independent of BP control with medications.Clinical Trial Registration:Registry: ClinicalTrials.gov, Title: A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension, Identifier: NCT00843583, URL:https://clinicaltrials.gov/ct2/show/NCT00843583Citation:Lui MM, Tse HF, Mak JC, Lam DC, Chan CW, Chong PW, Ip MS. Untreated obstructive sleep apnea is associated with myocardial injury independent of blood pressure co...
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
Study Objectives:An oral appliance (OA) is a validated treatment for obstructive sleep apnea (OSA). However, therapeutic response is not certain in any individual and is a clinical barrier to implementing this form of therapy. Therefore, accurate and clinically applicable prediction methods are needed. The goal of this study was to derive prediction models based on multiple awake assessments capturing different aspects of the pharyngeal response to mandibular advancement. We hypothesized that a multimodal model would provide robust prediction.Methods:Patients with OSA (apnea-hypopnea index [AHI]> 10 events/h) were recru...
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
Conclusions:This retrospective study illustrates that there are patients for whom PSG gave a false-negative study. Patients who had negative PSG and positive HSAT are more likely to be older and have the diagnosis of hypertension. Sleep physicians may consider repeat testing with HSAT in patients with a negative PSG and clinical symptoms of OSA.Commentary:A commentary on this article appears in this issue on page 1839.Citation:Lipatov K, Hayek A, Ghamande S, Boethel C, Chen W, Jones S. Predictors of obstructive sleep apnea on home sleep apnea test after a negative attended polysomnography.J Clin Sleep Med. 2018;14(11):1889–1894.
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
We present the case of a middle-aged man with SDB and persistent AF who exhibited improvement in SDB metrics, as characterized by data downloaded from his auto-titrating continuous positive airway pressure (AutoCPAP) machine, very shortly following procedures that restored sinus rhythm. Between procedures, when his rhythm reverted to AF, the downloaded parameters suggested more SDB events. After catheter ablation, the patient maintained sinus rhythm and the improvement in SDB metrics was sustained as well. This case provides support in favor of a bidirectional relationship between SDB and AF and suggests that data availabl...
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
Source: Journal of Clinical Sleep Medicine : JCSM - Category: Sleep Medicine Source Type: research
Conclusion: Our results demonstrated the highest AHI during REM sleep stage in total participants after control of posture. However, there were 16.2% of patients showed NREM-dominant pattern (AHINREM/AHIREM>2) and 6.8% of patients showed higher AHISWS than AHIN1N2. Therefore, each group might have a different pathophysiology of obstructive sleep apnea (OSA), and we need to consider this point when we treat the patients with OSA. PMID: 30415523 [PubMed - as supplied by publisher]
Source: Clinical and Experimental Otorhinolaryngology - Category: ENT & OMF Tags: Clin Exp Otorhinolaryngol Source Type: research
AbstractPurposeOur study aims to compare the difference in clinical efficacy between auto-trilevel positive airway pressure (auto-trilevel PAP) ventilator and conventional fixed bilevel positive airway pressure (BiPAP) ventilator for obesity hypoventilation syndrome (OHS) patients with coexisting moderate or severe obstructive sleep apnea hypopnea syndrome (OSAHS).MethodsTwenty-three OHS patients with moderate or severe OSAHS enrolled between January 2015 and September 2017 underwent ventilation by three different modes of positive airway pressure (PAP) for 8  h per night. A single variable mode was applied at the fir...
Source: Sleep and Breathing - Category: Respiratory Medicine Source Type: research
Abstract Recent studies have demonstrated that obstructive sleep apnea (OSA) is associated with the development and evolution of nonalcoholic fatty liver disease (NAFLD), independent of obesity or other shared risk factors. Like OSA, NAFLD is a prevalent disorder associated with major adverse health outcomes: Patients with NAFLD may develop cirrhosis, liver failure, and hepatocellular carcinoma. One major finding that has emerged from these studies is that the OSA/NAFLD association is related to the degree of nocturnal hypoxemia in OSA. Animal models have therefore largely focused on intermittent hypoxia, a key ma...
Source: American Journal of Respiratory and Critical Care Medicine - Category: Respiratory Medicine Authors: Tags: Am J Respir Crit Care Med Source Type: research
The Clinical Global Impression scale (CGI) reflects the clinician ’s assessment of the disease impact on patient's global functioning. We assessed predictors of CGI scale rating in patients with obstructive sleep apnea (OSA).
Source: Sleep Medicine - Category: Sleep Medicine Authors: Tags: Original Article Source Type: research
AbstractPatients with both heart failure and obstructive sleep apnea often have poor, repeatedly disrupted sleep, and yet they frequently do not complain of excessive daytime sleepiness. Understanding this lack of perceived sleepiness is crucial for the case identification and treatment of obstructive sleep apnea in the heart failure population at high risk of this disease, especially given the association between untreated obstructive sleep apnea and mortality among patients with heart failure. In this review, we present epidemiologic evidence concerning the lack of sleepiness symptoms in heart failure and obstructive sle...
Source: Journal of Sleep Research - Category: Neurology Authors: Tags: REVIEW PAPER Source Type: research
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