FDA panel votes against BTG ’ s PneumRX Elevair
An FDA advisory committee panel yesterday voted against approving BTG‘s PneumRX’s Elevair endobronchial coil system intended for treating patients with severe emphysema.
The panel voted 7 to 5 in favor of the device’s safety, but 8 to 3 that the benefits do not outweigh the risks, and 5 to 7 that the device was effective for use with patients in its proposed indications.
The Elevair device is a nitinol endobronchial coil intended to be deployed bronchoscopically to reduce lung volume in patients with severe emphysema. The company submitted an application for premarket approval with the FDA, backed by clinical...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Respiratory BTG Source Type: news
Emphysema from Crack Cocaine?
Title: Emphysema from Crack Cocaine?Category: Doctor's& Expert's views on SymptomsCreated: 6/24/2008 12:00:00 AMLast Editorial Review: 6/13/2018 2:55:06 PM (Source: MedicineNet Lungs General)
Source: MedicineNet Lungs General - June 13, 2018 Category: Respiratory Medicine Source Type: news
Endobronchial-Valve Treatment Improves Lung Function in Emphysema Endobronchial-Valve Treatment Improves Lung Function in Emphysema
Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - May 29, 2018 Category: Surgery Tags: Pulmonary Medicine News Source Type: news
Pulmonx Closing in On Approval for Valve to Treat Emphysema
Pulmonx has some additional ammunition in its bid to get its severe emphysema treatment valve FDA approval. The Redwood City, CA-based company released positive one-year-results from the LIBERATE pivotal trial of the Zephyr Endobronchial Valve, which shows the study met all primary and secondary endpoints in treating emphysema patients.
Emphysema falls under the umbrella of chronic obstructive pulmonary disease (COPD) and is characterized by damage to the walls of the lungs between the air sacs, according to the National Emphysema Foundation. This damage causes the sacs to lose their shape and often, the destruction of tho...
Source: MDDI - May 25, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Source Type: news
Pulmonx touts quality of life, lung function improvements in 1-year Zephyr endobronchial valve IDE study
This study was the largest, longest study to use a less-invasive or minimally-invasive technique using these one-way valves,” Dr. Criner said.
Dr. Criner said that after one year, patients treated with the Zephyr valves were significnatly more likely to show improvements in lung function, measured as forced expiratory volume in one second, or FEV1.
“Patients that were treated had about a three times greater likelihood of having significant improvement in FEV1, more than 15% in 45% of the treated group compared to 11% of the control,” Dr. Criner said.
Additionally, patients treated with the Zephyr reported...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Respiratory Pulmonx Source Type: news
Medical News Today: What to know about centrilobular emphysema
Centrilobular emphysema is a form of emphysema where the damage begins in the central lobes of the lungs and spreads outward. This is distinct from panlobular emphysema. In this article, we discuss centrilobular emphysema including symptoms, causes, complications, and possible treatments. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - May 22, 2018 Category: Consumer Health News Tags: COPD Source Type: news
What Are Complications of Oropharyngeal Trauma?
Discussion
Oropharyngeal trauma is common and ranges from minor contusions to severe trauma of the head and neck. Sudden movement while having a foreign object in the mouth is a very common scenario with falls or collisions being common mechanisms. Common objects include toys, sticks, pens/pencils, chopsticks, toothbrushes, and popsicle sticks. Many of these injuries cause minimal problems such as a contusion to lips (i.e. “fat lip”).
In general, the more anterior the location the more common the injury and the less likely to have a severe injury (i.e. lips). Whereas posterior structures are more protected, bu...
Source: PediatricEducation.org - April 16, 2018 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
5 Key Takeaways from Mesothelioma Expert Teleconference
If you have been diagnosed with mesothelioma, you’re likely seeking information and resources to learn more about the disease.
A free one-hour mesothelioma teleconference is a great place to start.
CancerCare recently hosted the “Advancements in the Treatment of Mesothelioma” workshop.
The session featured five mesothelioma experts, including Dr. Hedy Kindler, director of the mesothelioma program at the University of Chicago Comprehensive Cancer Center.
The Mesothelioma Applied Research Foundation co-sponsored the teleconference, which is available online for free.
All mesothelioma patients can benefit from the topi...
Source: Asbestos and Mesothelioma News - April 9, 2018 Category: Environmental Health Authors: Matt Mauney Source Type: news
Ask Have Emphysema Without Being a Smoker
Can You Have Emphysema Without Being a Smoker? (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - April 3, 2018 Category: General Medicine Source Type: news
EBV treatment cost effective for severe emphysema
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - April 1, 2018 Category: Drugs & Pharmacology Source Type: news
Pulmonary Edema vs Emphysema
Pulmonary Edema vs. Emphysema (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - March 8, 2018 Category: General Medicine Source Type: news
Zebra Medical wins CE Mark for brain-bleed detection algorithm
Israeli machine-learning radiology firm Zebra Medical Vision said today it won CE Mark approval in the European Union for an algorithm for detecting intracranial hemorrhages as part of its deep learning imaging analytics platform.
Zebra Medical said that its algorithm is designed to identify brain bleeds to provide extra support for physicians in acute care settings, and that it plans to use the algorithm for point-of-care detection to identify bleeds accurately and with reduced delay.
“This new algorithm is an important addition to Zebra’s Analytics Engine. The ability to alert radiologists and surgeons to the pr...
Source: Mass Device - March 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Neurological Regulatory/Compliance Software / IT Zebra Medical Vision Source Type: news
Widely Used COPD Meds Tied to Higher Fracture Risk
COPD -- often linked to smoking -- is a combination of emphysema and chronic bronchitis. It is a progressive, debilitating illness that currently has no cure. (Source: WebMD Health)
Source: WebMD Health - February 13, 2018 Category: Consumer Health News Source Type: news
Former S.D. dentist pleads guilty to $17m medtech fraud scheme
A former dentist from South Dakota plead guilty last week to a $16.6 million scheme to defraud consumers through the sale of a sham laser device and associated treatments, promising it would cure more than 200 different conditions, according to a US Department of Justice report.
The plea was the finale to a three-year effort from the DoJ to halt the distribution of the device, known as the “QLaser System”, according to the report.
The defendant, 82-year-old Robert Lytle of Rapid City, S.D., plead guilty to a single count of conspiracy to introduce misbranded medical devices into interstate commerce with the int...
Source: Mass Device - January 30, 2018 Category: Medical Devices Authors: Fink Densford Tags: Legal News Regulatory/Compliance U.S. Justice Dept. (DOJ) Source Type: news
Tom Petty Died Of Accidental Overdose: Coroner
Musician Tom Petty died of an accidental drug overdose, according to a statement from his wife and daughter that was posted online.Petty had been suffering from a fractured hip that got worse during his recent tour, along with emphysema and knee pain. (Source: WebMD Health)
Source: WebMD Health - January 20, 2018 Category: Consumer Health News Source Type: news
