How a New Emphysema Device Won FDA Approval in Six Months
FDA has approved a new device intended to treat breathing difficulty associated with severe emphysema. The approval comes just two weeks after an FDA advisory panel shot down a competing technology targeting the same patient population. The agency approved Pulmonx Inc.'s Zephyr endobronchial valve through the breakthrough device designation, a pathway reserved for devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. Devices also must meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives, or the availability of the device is in the best interest of patients. "I can really only sing the praises of FDA in this case," Beran Rose, vice president of marketing and business development at Pulmonx, told MD+DI. Not only did the agency grant the company a breakthrough device designation for the Zyphyr, but the product was approved in less than six months, Rose said. One of the advantages of qualifying for the breakthrough device designation is that FDA provides intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency's review of the product. FDA also did not require an advisory panel prior to making its decision. BTG wasn't so lucky. In Ju...
Conclusions: Our study shows that risk factors for new-onset atrial fibrillation during sepsis are mainly factors that are associated with the acute sepsis event and are not synonymous with risk factors for community-associated atrial fibrillation. Our results provide targets for future studies focused on atrial fibrillation prevention and have implications for several key areas in the management of patients with sepsis such as glucocorticoid administration, vasopressor selection, and blood pressure targets.
Conclusions: Percutaneous dilatational tracheostomy is associated with a considerable complication rate in veno-venous extracorporeal membrane oxygenation patients. Preprocedure circuit performance as indicated by extracorporeal membrane oxygenation postoxygenator PO2 is an independent predictor of major complications following percutaneous dilatational tracheostomy.
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No abstract available
ConclusionsThe application of rose oil aromatherapy by inhalation reduced the scores of preoperative anxiety of patients undergoing septorhinoplasty/rhinoplasty.
VITAMIN D is an essential vitamin needed to keep bones, teeth and muscles healthy, and a deficiency can cause problems with these body parts. Vitamin D deficiency can be common in the winter, but how do you know if you are deficient? Lower back pain could be one of the symptoms.
This article will review how physiological, pathological and pharmacological processes can influence all of these factors.
Natalie K öhler, Robert Zeiser
BLOATED stomach pain is usually brought on by eating foods and drinks which cause trapped wind and excess gas. Fizzy drinks are a common culprit - replace them with this soothing juice to relieve a bloated belly and stomach cramps.
Conclusion: Both lidocaine and bupivacaine caused postoperative cognitive impairment. Lidocaine was found to have a worse effect on cognitive function than bupivacaine, but the difference was not statistically significant. PMID: 30643450 [PubMed]
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