FDA: Zephyr Endobronchial Valve Approved for Severe Emphysema
FRIDAY, July 6, 2018 -- A new device, the Zephyr Endobronchial Valve (Zephyr Valve), has been approved by the U.S. Food and Drug Administration for the treatment of breathing difficulties associated with severe emphysema. During a procedure in a... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 6, 2018 Category: Pharmaceuticals Source Type: news
Redwood City company wins FDA approval for emphysema-treating medical device
For patients with severe emphysema, the new technology allows for treatment of the chronic disease without major invasive surgery. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - July 5, 2018 Category: Pharmaceuticals Authors: Kevin Truong Source Type: news
Redwood City company wins FDA approval for emphysema-treating medical device
For patients with severe emphysema, the new technology allows for treatment of the chronic disease without major invasive surgery. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 5, 2018 Category: Biotechnology Authors: Kevin Truong Source Type: news
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 app...
Source: MDDI - July 2, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
FDA Clears Zephyr Endobronchial Valve to Treat Severe Emphysema FDA Clears Zephyr Endobronchial Valve to Treat Severe Emphysema
The Zephyr valve is the first minimally invasive device approved in the US for treating patients with severe emphysema.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 29, 2018 Category: Consumer Health News Tags: Pulmonary Medicine News Alert Source Type: news
FDA Approves Novel Device for Treating Breathing Difficulty from Severe Emphysema
June 29, 2018 -- The U.S. Food and Drug Administration today approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema. “Treatment options are limited for... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 29, 2018 Category: Pharmaceuticals Source Type: news
FDA approves novel device for treating breathing difficulties associated with severe emphysema- https://go.usa.gov/xUYXd #FDA #MedicalDevice #COPDpic.twitter.com/do1EG38wMM
FDA approves novel device for treating breathing difficulties associated with severe emphysema- https://go.usa.gov/xUYXd #FDA #MedicalDevice #COPD pic.twitter.com/do1EG38wMM (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - June 29, 2018 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news
Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from ent...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Pulmonx Source Type: news
FDA approves novel device for treating breathing difficulty from severe emphysema
(Source: Food and Drug Administration)
Source: Food and Drug Administration - June 29, 2018 Category: American Health Source Type: news
FDA Panel Shoots Down Endobronchial Coil System – Is the Device Doomed?
BTG plc (LSE: BTG), the global specialist healthcare company, notes that the US Food & Drug Administration’s (FDA’s) Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee yesterday voted against the approval of the Elevair™ Endobronchial Coil System for the treatment of people with severe emphysema. The Panel voted as follows: that there is reasonable assurance that Elevair™ is safe for use in patients who meet the criteria specified in the proposed indication, while considering the additional procedures needed to maintain effectiv...
Source: MDDI - June 18, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Business Source Type: news
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 clin...
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
Say what? Smoking found to increase risk of hearing loss, according to study
(Natural News) Still dying for a smoke? Besides, emphysema, diabetes, rheumatoid arthritis, blindness and of course cancer, here’s one more reason to stop smoking — hearing loss. A recently-published study published by Oxford University Press showed that the more than 50,000 participants of the over eight year-study showed that “smoking is an independent risk factor... (Source: NaturalNews.com)
Source: NaturalNews.com - April 10, 2018 Category: Consumer Health News 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 f...
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
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 t...
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
Reports Confirm Petty Died of Accidental Drug Overdose
NEW YORK (AP) — Tom Petty died last year because of an accidental drug overdose that his family said occurred on the same day he found out his hip was broken after performing dozens of shows with a less serious injury. His wife and daughter released the results of Petty's autopsy via a statement Friday on his Facebook page, moments before coroner's officials in Los Angeles released their findings and the rocker's full autopsy report. Dana and Adria Petty say they got the results from the coroner's office earlier in the day that the overdose was due to a variety of medications. The coroner's findings showed Petty had ...
Source: JEMS: Journal of Emergency Medical Services News - January 19, 2018 Category: Emergency Medicine Authors: Nekesa Mumby Moody, Associated Press Tags: News Source Type: news
Genetic variation in lung airways elevates risk of COPD
CT scans show that a quarter of the adult population has nonstandard airway...Read more on AuntMinnie.comRelated Reading: AI algorithm predicts lung disease, adverse events on CT COPD severity mirrors lung cancer incidence AJR: Ultralow-dose CT can evaluate COPD Group issues call for best lung cancer, COPD protocols Emphysema-related COPD on CT signals higher malignancy risk (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 17, 2018 Category: Radiology Source Type: news
Regular Aspirin Use May Slow COPD Progression (CME/CE)
(MedPage Today) -- Analysis showed 50% reduction in emphysema progression (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - December 23, 2017 Category: Allergy & Immunology Source Type: news
British health agency backs endobronchial valves from Pulmonx, OIympus
Pulmonx and Olympus (TYO:7733) won a nod from a British health agency for the endobronchial valves they sell to treat severe emphysema. The U.K.’s National Institute for Health & Care Excellence updated its guidance for the valves, saying it considers the clinical evidence behind them sufficient to support routine use. The one-way valves, Pulmonx’s Zephyr and the Spiration device made by Olympus, are designed to partition diseased lung tissue from healthy tissue to improve respiratory efficiency. Redwood City, Calif.-based Pulmonx said the decision was based on data from a quartet of studies ...
Source: Mass Device - December 21, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Respiratory Olympus Pulmonx U.K. National Institute for Health & Care Excellence (NICE) Source Type: news
Rheumatoid arthritis: Symptoms could be signs of THESE lung diseases
Rheumatoid arthritis symptoms could cause some lung conditions, including emphysema and chronic bronchitis, researchers have warned. (Source: Daily Express - Health)
Source: Daily Express - Health - October 20, 2017 Category: Consumer Health News Source Type: news
These foods fight deadly lung disease
Your lungs are under constant assault. That’s why COPD is the third leading cause of death according to the U.S. Centers for Disease Control and Prevention. About 15 million Americans have it. COPD is short for chronic obstructive pulmonary disease. It’s a group of lung diseases like emphysema and chronic bronchitis. They constrict your airways. They make breathing difficult and can cause wheezing or coughing. Most doctors will tell you that smoking is the major culprit. But even if you never smoked you are still at risk of COPD. You see, our modern world is a big factor. Our air is full of chemicals. Bad air i...
Source: Al Sears, MD Natural Remedies - October 4, 2017 Category: Complementary Medicine Authors: Cathy Card Tags: Health Nutrition chronic obstructive pulmonary disease COPD lung disease lungs Source Type: news
FDA OKs Glaxo's inhaler, first one to combine 3 medicines
The FDA approves the first inhaler that combines three medicines to ease breathing in patients with emphysema or chronic bronchitis (Source: ABC News: Health)
Source: ABC News: Health - September 19, 2017 Category: Consumer Health News Tags: Health Source Type: news
Conventional household cleaners can kill you with increased risk of fatal lung disease
(Natural News) Chronic obstructive pulmonary disease (COPD) is a life-threatening condition that results in obstructed airflow and difficulty breathing. There are two main illnesses associated with COPD: Chronic bronchitis, which affects more than 10 million Americans, and emphysema, which over 4.7 million Americans have been diagnosed with. While the most common cause of COPD is... (Source: NaturalNews.com)
Source: NaturalNews.com - September 19, 2017 Category: Consumer Health News Source Type: news
Lung disease warning: This common household product could be linked to COPD risk
COPD - Chronic Obstructive Pulmonary Disease – is a common form of lung disease that includes emphysema and chronic bronchitis. (Source: Daily Express - Health)
Source: Daily Express - Health - September 11, 2017 Category: Consumer Health News Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 8, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters. 5. Resilience Capital Partners creates Innovatus Imaging Private equity firm Resilience Capital Partners recently announced that one of its funds has acquired three medical device service and manufacturing units, allowing the firm...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Broncus Medical affiliate acquires Uptake Medical
Uptake Medical said yesterday that its InterVapor device for treating emphysema is back on the market in Europe after its acquisition for an undisclosed amount by an affiliate of Broncus Medical. Broncus set its purchase up under a new entity based in Seattle, Uptake Medical Technology, and plans to add markets in Australia and Asia to its commercial footprint in Europe by the end of the year. The InterVapor device uses heated water vapor to reduce lung volume in emphysema patients. Uptake won an expanded CE Mark in the European Union for InterVapor in August 2015. “2018 promises to be an exciting year for ...
Source: Mass Device - September 8, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Respiratory Wall Street Beat Broncus Medical Uptake Medical Source Type: news
Endobronchial valve treatment appears to improve lung function in patients with severe emphysema
(American Thoracic Society) People with severe emphysema may breathe better after a minimally invasive procedure that places valves in the airways leading to diseased portions of their lungs, according to a randomized, controlled trial published online in the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - September 8, 2017 Category: International Medicine & Public Health Source Type: news
Relief for victims of lung disease found in a ketchup
The alloy and silicone device is being offered to NHS patients with emphysema and other incurable respiratory problems, collectively known as COPD. (Source: the Mail online | Health)
Source: the Mail online | Health - September 2, 2017 Category: Consumer Health News Source Type: news
Pulmonary Oxygen Uptake During Exercise in Emphysema and IPF Pulmonary Oxygen Uptake During Exercise in Emphysema and IPF
Gain a better understanding of the pulmonary oxygen uptake response during exercise in patients with emphysema and IPF.BMC Pulmonary Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 23, 2017 Category: Consumer Health News Tags: Pulmonary Medicine Journal Article Source Type: news
Title: EmphysemaCategory: Diseases and ConditionsCreated: 3/24/2008 12:00:00 AMLast Editorial Review: 8/22/2017 12:00:00 AM (Source: MedicineNet Lungs General)
Source: MedicineNet Lungs General - August 22, 2017 Category: Respiratory Medicine Source Type: news
COPD vs. Emphysema (Differences Similarities)
Title: COPD vs. Emphysema (Differences Similarities)Category: Diseases and ConditionsCreated: 7/27/2017 12:00:00 AMLast Editorial Review: 7/27/2017 12:00:00 AM (Source: MedicineNet Lungs General)
Source: MedicineNet Lungs General - July 27, 2017 Category: Respiratory Medicine Source Type: news
Could your ’smoker’s cough’ be a sign of this potentially life-threatening lung condition?
EMPHYSEMA is a type of lung condition that causes problems breathing, and it could turn dangerous. Here are the symptoms to look out for. (Source: Daily Express - Health)
Source: Daily Express - Health - May 23, 2017 Category: Consumer Health News Source Type: news
Psychological therapies for the treatment of anxiety disorders in chronic obstructive pulmonary disease.
Chronic obstructive pulmonary disease (COPD) (commonly referred to as chronic bronchitis and emphysema) is a chronic lung condition characterised by the inflammation of airways and irreversible destruction of pulmonary tissue leading to progressively worsening dyspnoea. It is a leading international cause of disability and death in adults. Evidence suggests that there is an increased prevalence of anxiety disorders in people with COPD. The severity of anxiety has been shown to correlate with the severity of COPD, however anxiety can occur with all stages of COPD severity. Coexisting anxiety and COPD contribute to poor heal...
Source: Current Awareness Service for Health (CASH) - May 22, 2017 Category: Consumer Health News Source Type: news
Research Supports Pulmonary Benefits for ACEIs, ARBs
Higher doses independently linked to slower change in emphysema, especially among former smokers (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - May 8, 2017 Category: Respiratory Medicine Tags: Cardiology, Family Medicine, Geriatrics, Internal Medicine, Nursing, Pharmacy, Pulmonology, Radiology, Journal, Source Type: news
How Common is α -1-Antitrypsin Deficiency?
Discussion α-1-Antitrypsin Deficiency (A1AT) is a common single-gene mutation disease that is homozygous recessive. The normal allele is called M and the most common abnormal allele is Z. There are other alleles though. The gene codes for one of the primary protease inhibitors in the serum, thus those who are homozygous for the Z gene are sometimes referred to as “PIZZ” or “PIZ.” α-1-Antitrypsin is found in all body tissues but is especially important in the serum and lung. As noted it is one of the primary neutrophil protease inhibitors in the serum, and acts to neutralize these enzymes...
Source: PediatricEducation.org - April 24, 2017 Category: Pediatrics Authors: pediatriceducationmin Tags: Uncategorized Source Type: news
What you need to know to make connected medical devices
Bill Welch, Phillips-Medisize [Image courtesy of Phillips-Medisize]The estimated number of connected medical devices – devices connected to the Internet –is expected to increase from 10 billion to 50 billion over the next decade, according to the IBM Institute for Business Value. This is due to the ability for machine-to-machine communication through cloud computing and networks of data-gathering sensors, also known as the Internet of Things (IoT) IT market, to add efficiency and cost savings to a wide range of enterprise tasks. It is a market that is anticipated to grow from $8.2 billion to over $12.4 billion ...
Source: Mass Device - April 12, 2017 Category: Medical Equipment Authors: Chris Newmarker Tags: Drug-Device Combinations mHealth (Mobile Health) Software / IT connected medical devices Phillips-Medisize Source Type: news
For Over 30 Years, A Son Chronicled His Mother's Life, Death And Love Of Cigarettes
James Friedman was 9 years old when he began photographing his mother, Dorothy. She was 11 years old when she smoked her first cigarette. They both continued with their respective fixations until the day Dorothy died. Friedman’s series “1,029,398 Cigarettes” chronicles his mother’s life over the course of 30 years and over a million cigarettes. The photos show the corrosive effects of chain-smoking in real time, spanning from before Dorothy was diagnosed with emphysema to her final days in the hospital. But more aptly, the images capture a son’s perspective of his imperfect but exce...
Source: Healthy Living - The Huffington Post - April 5, 2017 Category: Consumer Health News Source Type: news