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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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Purpose of review There is a high prevalence of obstructive sleep apnea (OSA) in the surgical population, however, a significant proportion of patients are undiagnosed. The Society of Anesthesia and Sleep Medicine (SASM) has issued recent guidelines for preoperative assessment and preparation of patients with known or suspected OSA. The purpose of this review is to highlight key points in the new guidelines and explore the possibilities of different strategies in optimizing patients with OSA preoperatively. Recent findings Recent knowledge on phenotypes and endotypes has provided a better understanding of the disease ...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
Purpose of review Increasing numbers of bariatric surgical procedures and the high prevalence of obstructive sleep apnea (OSA) in this population have resulted in a growing interest in the perioperative management of OSA in bariatric surgery. This review provides a summary of the first consensus guideline on this topic as well as an update of the newest literature available. Recent findings All bariatric patients should be screened for OSA and obesity hypoventilation syndrome (OHS) to reduce the risk of perioperative complications. Intraoperative precautions are preoxygenation, induction and intubation in ramped posit...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
Purpose of review The primary objective of this review is to identify the risk factors for opioid-induced respiratory depression (OIRD) in the postoperative period. Recent findings In the postoperative period, OIRD has often been reported resulting in morbidity and mortality. The risk factors which predispose surgical patients to increased risk of OIRD are not clearly defined. A literature search was performed for adult surgical patients who were prescribed opioids during their hospital stay and any available reports on postoperative respiratory depression/respiratory events. Summary Elderly, female sex, presence o...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
Purpose of review Provide a practical update on drug-induced sleep endoscopy (DISE) for anesthesia providers, which can also serve as a reference for those preparing to establish a DISE program. Recent findings New developments in surgical approaches to OSA and the growing global incidence of the condition have stimulated increased interest and demand for drug-induced sleep endoscopy. New techniques include transoral robotic surgery and hypoglossal nerve stimulation. Recent DISE literature has sought to address numerous debates including relevance of DISE findings to those during physiologic sleep and the most appropr...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
CONCLUSIONS: We recommend using a BMI cutoff value (28 kg/m2), and a STOP-Bang score ≥ 4 allows the anesthetist to identify patients with high risk of OSA. PMID: 29322383 [PubMed - as supplied by publisher]
Source: Sleep and Breathing - Category: Sleep Medicine Authors: Tags: Sleep Breath Source Type: research
ConclusionsWe recommend using a BMI cutoff value (28  kg/m2), and a STOP-Bang score ≥ 4 allows the anesthetist to identify patients with high risk of OSA.
Source: Sleep and Breathing - Category: Respiratory Medicine Source Type: research
Delirium is a common problem that occurs in 5 –50% of elderly individuals following surgery. Patients who develop delirium after surgery are at increased risk for serious complications. Recent studies suggest t...
Source: BMC Anesthesiology - Category: Anesthesiology Authors: Tags: Study protocol Source Type: research
Purpose of review There is a high prevalence of obstructive sleep apnea (OSA) in the surgical population, however, a significant proportion of patients are undiagnosed. The Society of Anesthesia and Sleep Medicine (SASM) has issued recent guidelines for preoperative assessment and preparation of patients with known or suspected OSA. The purpose of this review is to highlight key points in the new guidelines and explore the possibilities of different strategies in optimizing patients with OSA preoperatively. Recent findings Recent knowledge on phenotypes and endotypes has provided a better understanding of the disease ...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
Purpose of review Increasing numbers of bariatric surgical procedures and the high prevalence of obstructive sleep apnea (OSA) in this population have resulted in a growing interest in the perioperative management of OSA in bariatric surgery. This review provides a summary of the first consensus guideline on this topic as well as an update of the newest literature available. Recent findings All bariatric patients should be screened for OSA and obesity hypoventilation syndrome (OHS) to reduce the risk of perioperative complications. Intraoperative precautions are preoxygenation, induction and intubation in ramped posit...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
Purpose of review The primary objective of this review is to identify the risk factors for opioid-induced respiratory depression (OIRD) in the postoperative period. Recent findings In the postoperative period, OIRD has often been reported resulting in morbidity and mortality. The risk factors which predispose surgical patients to increased risk of OIRD are not clearly defined. A literature search was performed for adult surgical patients who were prescribed opioids during their hospital stay and any available reports on postoperative respiratory depression/respiratory events. Summary Elderly, female sex, presence o...
Source: Current Opinion in Anaesthesiology - Category: Anesthesiology Tags: MORBID OBESITY AND SLEEP APNEA: Edited by Frances F. Chung Source Type: research
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