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Respicardia wins FDA nod for Remed ē central sleep apnea neurostim device

Respicardia said today that it won FDA approval for its Remedē transvenous implantable neurostimulation system designed to treat patients with central sleep apnea. Central sleep apnea occurs when the brain fails to control breathing during sleep, unlike the more common obstructive sleep apnea which consists of a partially collapsed airway which causes pauses in breathing, Respicardia said. The Remedē system consists of a surgically placed battery packa nd thin wires inserted into the blood vessels in the chest near the phrenic nerve, which it stimulates to engage the diaphragm to restore natural breating during sleep and improve patient quality of life and satisfaction. “This implantable device offers patients another treatment option for central sleep apnea. Patients should speak with their health care providers about the benefits and risks of this new treatment compared to other available treatments,” FDA CDRH anesthesiology, general hospital, respiratory, infection control and dental devices acting director Tina Kiang said in a prepared FDA release. Approval of the device came based off data from the Minnetonka, Minn.-based company’s pivotal trial of the device, which had results published in the Lancet last September. The 151-patient, 31-hospital study aimed to explore the safety and effectiveness of a transvenous phrenic nerve stimulator which is designed to send regular signals to get the diaphragm to breathe during sleep. At 6-months, the number of ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance Respiratory Respicardia Source Type: news

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CONCLUSIONS: Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians, noncooperation in care by patients, and poor clinical documentation. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and documenting compliance and improvement with the treatment plan. Medical comorbidities such as obstructive sleep apnea and the use of long-acting opioids may be particularly dangerous. Continuing physician education on the safest and most effective approaches to manage thes...
Source: Anesthesia and Analgesia - Category: Anesthesiology Authors: Tags: Anesth Analg Source Type: research
CONCLUSIONS: Our meta-analysis demonstrates that after cardiac surgery, MACCEs and newly documented POAF were 33.3% and 18.1% higher odds in OSA versus non-OSA patients, respectively.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. PMID: 29049073 [PubMed - as supplied by publisher]
Source: Anesthesia and Analgesia - Category: Anesthesiology Authors: Tags: Anesth Analg Source Type: research
Abstract The number of operations carried out on an outpatient basis is increasing in Germany. This trend has been observed for years. The prerequisite is an infrastructure that is in line with guidelines. The competence of the anesthetist must not be restricted to that of a standard specialist anesthetist, but the physician should have experience in ambulatory anesthesia. Well-adjusted comorbidities of the patient are generally not a contraindication for an outpatient procedure. The heavily overweight patient can also be operated on an outpatient basis if he is compliant, comorbidities are well adjusted and inten...
Source: Anasthesiologie, Intensivmedizin, Notfallmedizin, Schmerztherapie : AINS - Category: Intensive Care Authors: Tags: Anasthesiol Intensivmed Notfallmed Schmerzther Source Type: research
A 51-year-old, 85-kg, 170-cm man with coronary artery disease, essential hypertension, hyperlipidemia, tobacco abuse, and obstructive sleep apnea was transferred to the authors ’ institution for evaluation of a 2-month history of recurrent fevers, chills, malaise, weakness, myalgia, and generalized arthralgias. The patient denied chest pain, dyspnea at rest or during exercise, palpitations, nausea, vomiting, and urinary symptoms. Two sets of blood cultures were positive for Streptococcus anginosus, but transthoracic echocardiography did not show vegetations.
Source: Journal of Cardiothoracic and Vascular Anesthesia - Category: Anesthesiology Authors: Tags: Diagnostic Dilemma Source Type: research
The purpose of this study was to evaluate and correlate long term subjective neurosensory recovery and oral function following maxillomandibular advancement in adult obstructive sleep apnea.
Source: Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Authors: Tags: Oral Abstract Track Two: Anesthesia, Infection, OSA, Orthognathic Source Type: research
There is a paucity of information on the long term subjective effect of maxillomandibular advancement (MMA) on obstructive sleep apnea (OSA). The purpose of this study was to investigate the effect of MMA on long term patient perceived quality of life (QOL) in OSA.
Source: Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Authors: Tags: Oral Abstract Track Two: Anesthesia, Infection, OSA, Orthognathic Source Type: research
Distinct comorbidity profiles have not been well defined for obstructive sleep apnea (OSA) patients treated with maxillomandibular advancement (MMA) compared to those managed medically. Surgical OSA patients commonly have contributing anatomic findings such as mandibular retrognathia, constricted posterior airway space, and increased upper airway length (1). Body mass index (BMI) may be less of a factor in the development of OSA in patients that undergo MMA. It was therefore hypothesized that surgical patients have fewer medical comorbidities compared to nonsurgical OSA patients.
Source: Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Authors: Tags: Oral Abstract Track Two: Anesthesia, Infection, OSA, Orthognathic Source Type: research
Maxillomandibular advancement is an effective surgical treatment for medically refractory moderate to severe obstructive sleep apnea. Different degrees and vectors of bony advancements increase upper airway dimensions as a result of their soft tissue attachments. Previous studies have analyzed clinical efficacy by demonstrating increased airway dimension on pre and post-operative imaging, sleep study results, and drug induced sleep endoscopy (DISE). These studies are limited to analyzing the effects of single movements.
Source: Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Authors: Tags: Oral Abstract Track Two: Anesthesia, Infection, OSA, Orthognathic Source Type: research
Condition:   Obstructive Sleep Apnea Interventions:   Other: Pre-operative: OSA Risk Identification;   Procedure: Intra-operative: Regional Anesthetic Techniques;   Drug: Intra-operative: Sedation Techniques;   Other: Post-operative: Intensified Monitoring and Care Sponsors:   University of British Columbia;   Vancouver Coastal Health Research Institute Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
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