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...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Authors: Oshagbemi OA, Franssen FME, van Kraaij S, Braeken DCW, Wouters EFM, Maitland-van der Zee AH, Driessen JHM, de Vries F Abstract Although recently introduced in the pharmacological treatment algorithm of chronic obstructive pulmonary disease (COPD), there is a need for more data supporting the use of blood eosinophil counts as a biomarker to guide inhaled corticosteroids (ICS) therapy. The aim of this study was to evaluate the risk of moderate and/or severe exacerbations and all-cause mortality in a large primary care population after withdrawal of ICS compared to continued users stratified by elevated blood...
Source: COPD: Journal of Chronic Obstructive Pulmonary Disease - Category: Respiratory Medicine Tags: COPD Source Type: research
Publication date: September 2019Source: Journal of Trace Elements in Medicine and Biology, Volume 55Author(s): Nasim Zamani, Hossein Hassanian-Moghaddam, Hooman Bahrami-Motlagh, Sara Ahmadi, Scott PhillipsAbstractObjectivesOur study attempts to determine if for patients following ingestion of lead-contaminated opium, radiographs [plain X-ray (KUB)] or unenhanced computed tomography (CT scan) of the abdomen may be predictive of lead poisoning.MethodsOur study is concerned with patients of>21 years with elevated lead concentrations, who had undergone KUB or CT. Patients with other toxicities who had undergone similar imag...
Source: Journal of Trace Elements in Medicine and Biology - Category: Biochemistry Source Type: research
ConclusionsThe comparison of different DBDs provided insight into the mechanism of DBD-induced SC permeabilization. It also illustrated the need to tailor electrical characteristics of a DBD to optimize it for a particular treatment modality. For future applications in drug delivery it would be beneficial to monitor the permeabilization during a plasma treatment.General significanceOur results provide mechanistic insight into the potential of an emerging interdisciplinary technology – plasma medicine – as a prospective tool or treatment option. While it might become a safe and pain-free method to enhance skin p...
Source: Biochimica et Biophysica Acta (BBA) General Subjects - Category: Biochemistry Source Type: research
CRNAs will continue to push to replace anesthesiologists as evident by the recent ridiculous AANA statement. Frankly, what AANA claims disgusts me, but at the same time, I am very disappointed to see that ASA is not responding in any meaningful way. This gives me very little hope regarding the future of the specialty, and makes me think that I chose the wrong field. I chose Anesthesiology because I loved the clinical aspect of it. I always knew the issues regarding CRNA, but did not know it... To young attendings: Do you regret choosing anesthesiology?
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Anesthesiology Source Type: forums
Publication date: Available online 23 May 2019Source: Best Practice &Research Clinical RheumatologyAuthor(s): Lindsay Lally, Robert SpieraAbstractPolymyalgia rheumatica (PMR) and giant cell arteritis (GCA) represent a family of systemic inflammatory diseases occurring in adults aged 50 years and above. Clinical presentation of PMR/GCA can be variable, making diagnosis at times challenging. There has been an increased appreciation of the role of various large-vessel imaging modalities to help confirm a diagnosis of GCA. Systemic corticosteroids (CS) remain the mainstay of treatment for both PMR and GCA, yet both relapse...
Source: Best Practice and Research Clinical Rheumatology - Category: Rheumatology Source Type: research
I'm in this position now making changes to my 4th yearschedule and would like any suggestions. I currently have my home anesthesia, 1 away, medicine AI, ICU elective, cardiology elective, and emergency med (all required). I already have sleep med (planning to change, heard from 4th years it's not that good), ICU procedures (essentially night shift, 4th years said it's ok), and online anatomy. I'm thinking of adding online radiology but I still need some more stuff. I'm currently looking at... 4th year electives for anesthesia
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Medical Students - MD Source Type: forums
Authors: Yuan S, Ma F, Wang Y, Gong P Abstract Introduction: Pyogenic spondylodiscitis is a bacterial infection affecting the intervertebral disc and its adjacent vertebrae. Although relatively rare, it is a challenging medical disease with a poor prognosis that requires immediate diagnosis and treatment with suitable antibiotics. Aim: To evaluate the clinical outcome of minimally invasive spine surgery (MIS) for pyogenic spondylodiscitis. Material and methods: The retrospective study cohort consisted of 10 consecutive patients who had undergone MIS decompression and/or discectomy for thoracic or lumbar pyo...
Source: Videosurgery and Other Miniinvasive Techniques - Category: Surgery Tags: Wideochir Inne Tech Maloinwazyjne Source Type: research
Conclusions: We believe that uniportal VATS is a safe, feasible, and effective technique for selected bronchiectasis patients. PMID: 31118998 [PubMed]
Source: Videosurgery and Other Miniinvasive Techniques - Category: Surgery Tags: Wideochir Inne Tech Maloinwazyjne Source Type: research
Authors: Onuk Ö Abstract Introduction: Mid-urethral slings, including transobturator tape (TOT), tension-free vaginal tape (TVT), tension-free vaginal tape-obturator (TVT-O), and a single incision sling, are the most popular procedures for the treatment of stress urinary incontinence (SUI). Although the classical TOT procedure is a minimally invasive technique, we believe that this technique can be further improved. Aim: To determine whether there was a difference in success and complication rates between the classical TOT technique and a novel technique called "modified transobturator tape" (mTO...
Source: Videosurgery and Other Miniinvasive Techniques - Category: Surgery Tags: Wideochir Inne Tech Maloinwazyjne Source Type: research
Conclusions: The conversion rate to CLA was 15.9%. Serum C-reactive protein level and complicated appendicitis were strong predictive factors for conversion from SPLA in acute appendicitis. PMID: 31118987 [PubMed]
Source: Videosurgery and Other Miniinvasive Techniques - Category: Surgery Tags: Wideochir Inne Tech Maloinwazyjne Source Type: research
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