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 public health problem. For many patients with severe asthma, even high doses of standard of care medications taken daily do not prevent frequent asthma attacks, which can be life-threatening," said Mario Castro, MD, Professor of Medicine at the Washington University School of Medicine, who presented data on the AIR2 Trial as the principal investigator. "We are hopeful that the FDA will concur with the recommendation made by the Panel today to make this procedure available to patients with severe asthma who have an enormous unmet medical need."

In the period immediately following bronchial thermoplasty, there is an expected transient increase and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within seven days with standard care. In the long term, fewer bronchial thermoplasty treated patients reported respiratory adverse events and there was a significant decrease in patients reporting asthma (multiple symptoms) adverse events in the Alair-treated group compared to the sham control group.

About Bronchial Thermoplasty Delivered by the Alair System

Bronchial thermoplasty is a non-drug procedure for asthma. The treatment is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient's nose or mouth and into their lungs. The tip of the small diameter Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.

CAUTION: The Alair System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.

Alair is a registered trademark of Asthmatx Inc.

About Asthmatx

Asthmatx is developing catheter-based medical devices for the treatment of asthma. Asthmatx has developed the Alair System to perform an investigational outpatient procedure called bronchial thermoplasty. The Alair System has received a CE Mark for use in the European Union. For more information on Asthmatx visit www.asthmatx.com.

SOURCE Asthmatx Inc.


'/>"/>
SOURCE Asthmatx Inc.
Copyright©2009 PR Newswire.
All rights reserved

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:2/10/2016)... , February 10, 2016 Puerto ... --> Puerto Rico Healthcare and Life Sciences Report 2016 ... 61 page Puerto Rico Healthcare and Life Sciences Report ... insights into the fifth largest territory in the world for ... medical device and diagnostics manufacturing, and more universities per square ...
(Date:2/10/2016)... 10, 2016 CERS ), Medivation, Inc. ... ) and Celldex Therapeutics, Inc. (NASDAQ: CLDX ). ... Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS ) and Celldex Therapeutics, ... Orphan Drug Designations become vitally important in the development of ... drugs and biologics which are defined as those intended for ...
(Date:2/10/2016)... ALBANY, New York , February 10, 2016 ... Share, Growth, Trends and Forecast 2015 - 2023 ", reveals ... a rather slow growth from 2015 to 2023 owing to ... register a meager CAGR of 1.30% during the forecast period, ... 2014 to US$38.9 bn in 2023. --> Antibacterial ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... ... LaserShip, a regional parcel carrier that services the eastern U.S., donated and delivered ... order to aid in the Flint water crisis. In 2014, LaserShip acquired Prestige Delivery ... only 15 miles away from Flint. , “We have deep roots in the local ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... unveiling its revolutionary new 2.0 version at the International Roofing Expo in Orlando, ... power of the world's most advanced weather technology in the hands of consumers, ...
(Date:2/10/2016)... NASHVILLE, Tenn. (PRWEB) , ... February 10, 2016 ... ... by the American Academy of Emergency Medicine , an emergency medicine ... of practice management services . , The American Academy of Emergency Medicine, ...
(Date:2/10/2016)... ... 2016 , ... Emergency rooms provide emergency care to stabilize critical health issues, ... with dental emergencies at risk of losing a tooth or their smiles. Dr. Marine ... Common dental emergencies include:, , Avulsed or knocked-out teeth , ...
(Date:2/10/2016)... CO (PRWEB) , ... February 10, 2016 , ... Dr. ... announce the practice is now accepting new dental patients and families in the North ... exceptional dental care services from cleanings to cosmetic dentistry, and all in the most ...
Breaking Medicine News(10 mins):