Navigation Links
Asthmatx Receives FDA Advisory Panel Recommendation for Approvable with Conditions for Bronchial Thermoplasty with the Alair(R) System for Severe Asthma
Date:10/28/2009

GAITHERSBURG, Md., Oct. 28 /PRNewswire/ -- Asthmatx Inc., announced today that the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the Alair® System, a device utilized in bronchial thermoplasty for the treatment of severe persistent asthma in patients 18 years and older, be found approvable with conditions.

The Anesthesiology and Respiratory Therapy Devices Panel voted 6 to 1 in favor of approvable with conditions, which were primarily related to labeling and post-approval studies. The final decision regarding the approval of the device is made by the FDA and while the FDA is not required to follow the advice of its advisory committee, it generally does.

"The Advisory Panel's recommendation for approvable with conditions of the Alair System marks a major step in bringing this new and important treatment option to patients with severe asthma," said Glen French, CEO of Asthmatx. "We look forward to working with FDA through the next steps to product approval."

Bronchial thermoplasty is a novel, non-drug procedure developed to treat adults with severe asthma and is designed to provide improved asthma quality of life and control that lasts for at least one year. Bronchial thermoplasty delivered by the Alair System uses thermal energy to reduce the muscle associated with airway constriction in asthma patients. The Committee reviewed the results of the AIR2 Trial, which found that in the year following bronchial thermoplasty, treated patients with severe asthma experienced the following benefits:

  • Significant improvement in quality of life
  • 32 percent reduction in severe asthma attacks
  • 84 percent reduction in emergency room visits for respiratory symptoms
  • 66 percent reduction in days lost from work/school or other activities

"Asthma is a serious
'/>"/>

SOURCE Asthmatx Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)
2. Lumenis Receives 510K Clearance for the PolyScope Disposable Flexible Endoscope
3. Dr. Mark Popovsky Receives Prominent Award for Leadership in Transfusion Medicine
4. Pharmalink AB Receives Patent for Nefecon(R) Principle
5. Solos Endoscopy, Inc. Receives Additional Purchase Orders from National Cancer Institute and National Institute of Health for its MammoView(TM) Product Line
6. Ikaria Receives Award for Excellence by New Jersey Business & Industry Association
7. NASCSA Receives $200,000 Grant From Purdue Pharma L.P. to Support State Prescription Drug Monitoring Programs
8. Jennerex, Inc. Receives EMEA Orphan Drug Designation for JX-594 for the Treatment of Hepatocellular Carcinoma
9. Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C
10. Solos Endoscopy, Inc. Receives Multiple Purchase Orders for its MammoView(TM) Product Line
11. WorldHeart Receives IRB Approval at First Center in the Levacor(TM) VAD BTT Clinical Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... , July 30, 2015 ... research report with market overview, trends, DRO ... porter analysis, recent developments, competitive scenario and ... Industry Insight: Biosensors Market Development and Demand ... http://photos.prnewswire.com/prnh/20150727/756778 ) Explore more ...
(Date:7/30/2015)... , July 30, 2015 Vermillion, ... on gynecologic disease, announced today it will ... after the market close on Thursday, August ... call and webcast at 4:30pm Eastern.Conference Call ... at 4:30pm Eastern/1:30pm Pacific  Domestic: ...
(Date:7/30/2015)... What can be expected from the ... grow at the fastest rates? Visiongain ,s brand ... data, trends, opportunities and prospects there. Our ... graphs. Discover the most lucrative areas in the industry ... you assess forecasted sales at overall world market and ...
Breaking Medicine Technology:Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 2Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 3Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 4Global Biosensors Market (Size of $12,964 Million in 2014) to Witness 10% CAGR During 2015 - 2020 5Ophthalmic Devices Market Forecast 2015-2025 - Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 2Ophthalmic Devices Market Forecast 2015-2025 - Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 3Ophthalmic Devices Market Forecast 2015-2025 - Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 4Ophthalmic Devices Market Forecast 2015-2025 - Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 5Ophthalmic Devices Market Forecast 2015-2025 - Future Prospects for Leading Companies in Vision Care, Surgical, Diagnostic & Monitoring Devices 6
... 2011 The University of California, Los Angeles (UCLA) ... soon become the third oncology research center in the ... a privately held medical device company. ViewRay,s new research ... patented combination of radiotherapy delivery and simultaneous magnetic resonance ...
... Nearly three quarters of the medical ... from developed markets, but the next wave of growth is ... unique needs of the India market, according to preliminary findings ... which were presented today at AdvaMed 2011, the annual MedTech ...
Cached Medicine Technology:UCLA Health System - Jonsson Comprehensive Cancer Center to Acquire ViewRay Radiation Therapy Research System 2Made in India, for India, is Next Wave of Growth for Region's Medical Technology Sector 2Made in India, for India, is Next Wave of Growth for Region's Medical Technology Sector 3
(Date:7/30/2015)... ... 31, 2015 , ... Reduce Human Error on the Drug ... and Ginette M. Collazo, Inc.**, Sept. 16-17, 2015 – Raleigh, NC, http://www.fdanews.com/humanerrordrugdevice ... and device firms reduce manufacturing errors by 50 percent or more, will conduct ...
(Date:7/30/2015)... ... ... On July 22nd the Bradenton Herald reported the Opioid Task ... the heroin outbreak. Ultimately the committee expressed lack of funding, and the absence of ... in North Florida. The task force has proposed to instate counselors to meet with ...
(Date:7/30/2015)... ... July 30, 2015 , ... World Patent Marketing, a vertically ... invention that can help people during emergencies. , "The worldwide mobile health market ... Director of World Patent Marketing. "Currently, there are about 97,000 mobile health apps ...
(Date:7/30/2015)... Texas (PRWEB) , ... July 30, 2015 , ... ... Path Institute (C-Path), and TransCelerate BioPharma, Inc. are pleased to announce that data ... have been published for use on the CDISC website . These three ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... In an ... are hospitalized, Dr. Aggarwal is making a change in his practice. , The decision ... Effective August 14, 2015, Dr. Aggarwal will be transferring his in-patient admissions to the ...
Breaking Medicine News(10 mins):Health News:FDAnews Announces — Reduce Human Error on the Drug and Device Manufacturing Floor: Reduce Errors By 50% or More Workshop, Sept. 16-17, 2015 2Health News:FDAnews Announces — Reduce Human Error on the Drug and Device Manufacturing Floor: Reduce Errors By 50% or More Workshop, Sept. 16-17, 2015 3Health News:FDAnews Announces — Reduce Human Error on the Drug and Device Manufacturing Floor: Reduce Errors By 50% or More Workshop, Sept. 16-17, 2015 4Health News:Manatee County’s Opioid Task Force Calls for More Funding and Face to Face Counseling After Overdose 2Health News:Manatee County’s Opioid Task Force Calls for More Funding and Face to Face Counseling After Overdose 3Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 2Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 3Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 4Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 5Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 2Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 3Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 4Health News:CDISC Releases Clinical Research Data Standards for Schizophrenia, Hepatitis C and Dyslipidemia 5Health News:River Valley Physician Dr. Aggarwal is Making Changes to his Practice 2
... Extension of Medicare Secondary Payer (MSP),for Kidney Dialysis ... for Patients, WASHINGTON, Oct. 22 In ... (CHAMP) Act of 2007,provision to extend Medicare Secondary ... program for patients who rely on dialysis care, ...
... its impressive past,successes, the Midwest Orthopaedic Research Foundation ... propel it forward in the coming decade. This,vision, ... will solidify MORF as a world-class research institution ... will be restructuring the board of directors,and embarking ...
... Care Access for Marylanders, WASHINGTON, Oct. 22 ... special session to resolve a state,budget shortfall, a ... $1 cigarette tax increase would dramatically reduce,youth smoking, ... costs and save thousands of lives., Governor ...
... water, sanitation would make all the difference, report finds ... childrens lives could be saved by a coordinated global ... sanitation and cleaner household fuels in underdeveloped countries, a ... would spare the lives of almost 1.5 million children ...
... Oct. 22 Deep Breeze Ltd., the leader ... its,VRIxp(TM) lung imaging system will now be available ... system that allows healthcare providers to,see and monitor ... or an,invasive procedure. The Company announced the phased ...
... and,other U.S. donors increased their charitable contributions to health ... increase to $7.9,billion was substantially lower than the 16 ... according to a new "Report on Giving" issued today,by ... are being eroded and the health care system is,being ...
Cached Medicine News:Health News:Kidney Care Community Voices Strong Support for Kidney Patients' Right to Choose 2Health News:Kidney Care Community Voices Strong Support for Kidney Patients' Right to Choose 3Health News:New Report: Increasing Maryland's Cigarette Tax Will Reduce Smoking, Save Lives and Save Money 2Health News:Saving Millions of Children's Lives Is Possible 2Health News:Deep Breeze Ltd. Launches Unique Non-Invasive, Radiation-Free Pulmonary Imaging System in the U.S. 2Health News:Deep Breeze Ltd. Launches Unique Non-Invasive, Radiation-Free Pulmonary Imaging System in the U.S. 3Health News:Philanthropic Giving for Health Care Slows in 2006 in both U.S. and Canada, According to Association for Healthcare Philanthropy's Annual 'Report on Giving' 2Health News:Philanthropic Giving for Health Care Slows in 2006 in both U.S. and Canada, According to Association for Healthcare Philanthropy's Annual 'Report on Giving' 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: