Navigation Links
FDA Approves New Device for Adults with Severe and Persistent Asthma

SILVER SPRING, Md., April 27 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.


The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

The device is composed of a catheter with an electrode tip that delivers a form of electromagnetic energy, called radiofrequency energy, directly to the airways. A controller unit generates and controls the energy.

Inflammation causes the airways of people who have asthma to swell and narrow, making breathing difficult. The Alair system treats asthma symptoms by using radiofrequency energy to heat the lung tissue in a controlled manner, reducing the thickness of smooth muscle in the airways and improving a patient's ability to breathe. To benefit, patients will require multiple sessions targeting different areas in the lungs.

"The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The trial showed a reduction of severe asthma attacks with use of the Alair system.

The FDA is requiring a five-year post-approval study of the device to study its long-term safety and effectiveness. The device manufacturer, Asthmatx, will follow many of the patients who were enrolled in the clinical trial and enroll 300 new patients at several medical centers across the United States.

Possible side effects during the course of treatment may include asthma attacks, wheezing, chest tightness or pain, partially collapsed lung (atelectasis), coughing up blood (hemoptysis), anxiety, headaches, and nausea. The Alair system is designed to reduce the number of severe asthma attacks on a long-term basis. However, there is a risk of immediate asthma attacks during the course of the treatment.

The Alair system is not for use in asthma patients with a pacemaker, internal defibrillator, or other implantable electronic device. Also, those patients with known sensitivities to lidocaine, atropine, or benzodiazepines should not use the device.  Alair has not been studied for success in retreatment of the same area of the lung. Currently, patients should not be retreated with the Alair system in the same area of the lung.  

Asthma patients considering the Alair system should not be treated while the following conditions are present: an active respiratory infection, coagulopathy (bleeding disorder), asthma exacerbations, or if they have had changes to their corticosteroid regimen 14 days before the proposed treatment.

Asthmatx Inc. is based in Sunnyvale, Calif.

For more information:

Medical Device Approvals at FDA

Media Inquiries: Dick Thompson, 301-796-7566,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels
2. FDA Approves First of Its Kind, Fully Implantable (Surgically), Invisible, Prosthetic Hearing Restoration Device
3. FDA Approves First Totally Implanted Hearing System
4. FDA Approves Watsons TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
5. FDA Approves Name Change for Heartburn Drug Kapidex
6. FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
7. FDA Approves First New Inhaled Antibiotic for CF in More Than a Decade
8. FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinsons Disease
9. FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
10. FDA Approves Xiaflex for Debilitating Hand Condition
11. FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
Post Your Comments:
(Date:11/25/2015)... LYON , Frankreich, November 25, 2015 ... hat heute bekanntgegeben, dass sie eine Lizenz für das ... Inserm, Poxel, CNRS, UCBL und ENS-Lyon innehaben, an Enyo ... 2009 von FUI AAP8 ins Leben gerufenen und von ... NATHEB-Programms wurde FXR als ein Behandlungsziel für HBV identifiziert, ...
(Date:11/24/2015)... Nov. 24, 2015  Natera, Inc. (Nasdaq: ... genetic testing and the analysis of circulating ... present at the 27 th  Annual Piper ... 2015 at 1:00 p.m. ET.  Matthew Rabinowitz, Ph.D., CEO of ... business activities and financial outlook. ...
(Date:11/24/2015)... , 24. November 2015 Avery ... Pacemaker Systems, ist erfreut, die Berufung von ... bekannt geben zu können. ... --> Foto - ... (Schweden). Von 1984-1986 war er Fellow des ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical Director at the Ageless ... treatment with the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, ... without the need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro ...
(Date:11/25/2015)... ... November 25, 2015 , ... Lakeview Health, ... country to celebrate their sobriety and show through pictures what a positive difference ... photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram ...
(Date:11/25/2015)... , ... November 25, 2015 , ... On November 23rd ... Tri Lite’s personal heating products business. Cozy Products explains what this means ... that fit in well with the Cozy Products business model: to sell personal heaters ...
(Date:11/25/2015)... MI (PRWEB) , ... November 25, 2015 , ... In ... Presence Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy ... medical and surgical intensive care units (totaling 30 beds) from May 2014 through October ...
(Date:11/25/2015)... PA (PRWEB) , ... November 25, 2015 , ... ... treat my cancer, I found that regular bras were incredibly uncomfortable," said an ... developed this specialized bra." , She developed the patent-pending RECOVERY BRA for added ...
Breaking Medicine News(10 mins):