Navigation Links
FDA Approves New Device for Adults with Severe and Persistent Asthma
Date:4/27/2010

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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov

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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Dublin ... the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global market ... its applications in various applications. The report deals with ... main industries: pharmaceutical and biotechnology, food and beverage, and ...
(Date:6/24/2016)... , June 24, 2016 Research ... World Market for Companion Diagnostic Tests" report to their ... Market for Companion Diagnostics The World Market ... and personalized medicine diagnostics. Market analysis in the report includes ... Test Market (In Vitro Diagnostic Kits) by Region (N. America, ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):