Asthmatx, Inc. Alair Bronchial Thermoplasty System - P080032
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Alair Bronchial Thermoplasty System
PMA Applicant: Asthmatx, Inc.
Address: 888 Ross Drive, Suite 100 Sunnyvale, CA 94089
Approval Date: April 27, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032a.pdf
What is it? The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy.
How does it work? The Alair Bronchial Thermoplasty System treats severe persistent asthma by delivering thermal radiofrequency energy to the airway wall to heat the tissue in a controlled manner in order to reduce airway smooth muscle mass (muscle thickness). Patients are treated in multiple sessions, each targeting a different area of the lungs.
When is it used? The Alair Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well-controlled with inhaled corticosteroids and long-acting beta-agonist medicines.
What will it accomplish? The Alair Bronchial Thermoplasty System reduces the number of severe asthma attacks that require systemic corticosteroid medicines in patients with severe, persistent asthma. Possible side-effects over the course of the treatments include asthma attacks, wheezing, chest discomfort, chest pain, partial collapse of the lungs (atelectasis), lower airway bleeding (hemoptysis), anxiety, headaches, and nausea.
When should it not be used? Patients with the following conditions should not be treated:
- Presence of a pacemaker, defibrillator, or other implantable electronic devices.
- Known sensitivity to medicines required to perform an internal examination of the airways (bronchoscopy), including lidocaine, atropine, and benzodiazepines.
- Patients previously treated with the Alair System should not be retreated in the same area(s). No clinical data are available studying the safety and/or effectiveness of repeat treatments.
Patients should not be treated while the following conditions are present:
- Active respiratory infection.
- Severe asthma attacks or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days.
- Known problems with blood coagulation (coagulopathy).
- As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin and non-steroidal anti-inflammatory drugs (NSAIDS) before the procedure with physician guidance.
Additional information: Summary of Safety and Effectiveness and labeling are available online.