Asthmatx and Virginia Hospital Center Treat First Patient with Bronchial Thermoplasty Following FDA Approval
SUNNYVALE, Calif., May 10 Asthmatx, Inc. reported today that doctors at Virginia Hospital Center in Arlington, Va., recently treated the first U.S. patient with bronchial thermoplasty (BT) delivered by the AlairŪ System, the first device-based asthma treatment approved by the U.S. Food and Drug Administration (FDA).
The novel outpatient procedure delivers controlled thermal energy to reduce excess airway smooth muscle that is associated with airway constriction in patients with asthma. By decreasing the ability of the airways to constrict, this new treatment has been shown to help patients with severe asthma gain substantially better control over their disease.
"We are honored to be the first hospital offering this new procedure to adults suffering with severe asthma in the DC metro area," said David R. Duhamel, M.D., Director of Pulmonary Special Procedures and the Lung Cancer Center at Virginia Hospital Center. "Bronchial thermoplasty is a promising new tool in the limited arsenal of physicians treating patients with severe asthma that has the potential to reduce hospital visits, out-of-pocket healthcare costs, and days missed from work due to asthma symptoms."
"This definitive intervention provides a long-term benefit to adult asthma patients and improves the quality of life for those suffering from this chronic condition," said Jeff B. Hales, M.D., Chief, Division of Pulmonary Critical Care and Sleep Medicine at Virginia Hospital Center. Dr. Hales and Dr. Duhamel were investigators in the Asthma Intervention Research 2 (AIR2) Trial.
The recent FDA approval of the Alair System was largely based on the positive results of the AIR2 Trial, a double-blind, randomized, sham-controlled study. Not only did the trial demonstrate that patients treated with the Alair System experienced improvement in their asthma quality of life after one year over patients who received a sham treatment, but these patients also experienced a reduction in asthma attacks, emergency room visits and hospitalizations for respiratory symptoms and days lost from work/school or other daily activities due to asthma.
The first patient treated with bronchial thermoplasty had hoped to be involved in the AIR2 Trial, however the study enrollment was complete when he first met with Dr. Hales. "I've been waiting for several years to have this procedure performed and am delighted to be the first patient treated after the FDA approval," said Anthony Cook, a lifelong asthma sufferer who testified at the FDA panel hearing in October for the device's approval. "I look forward to joining the rest of the AIR2 Trial participants who have benefited from the treatment as I honestly believe that bronchial thermoplasty is one of the greatest innovations for severe asthma patients."
"The timing of the first patient treated with BT is remarkable in that just last week the Global Initiative for Asthma (GINA) organized World Asthma Day to increase awareness and improve treatment of asthma," stated Glen French, CEO of Asthmatx. "GINA announced a goal of reducing hospitalizations from asthma by 50 percent over the next 5 years, and the appropriate use of BT is expected to contribute substantially to the realization of this goal."
Patients in the Washington DC metro area that are interested in learning more about BT should call the BT Hotline at (703) 236-7173.
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the Asthma and Allergy Foundation of America (AAFA), more than 20 million Americans have asthma, and managing asthma consumes over $18 billion of healthcare resources each year. In the U.S. each year, asthma attacks result in approximately 10 million outpatient visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 4,000 deaths.
For more information about the Global Initiative for Asthma, visit www.ginasthma.com.
About Bronchial Thermoplasty Delivered by the Alair System
Bronchial thermoplasty is a bronchoscopic procedure 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 agonists. Bronchial thermoplasty 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 excess airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under moderate sedation, and the patient returns home the same day.
In the period immediately following bronchial thermoplasty, the most common side effect is an expected transient increase in the frequency 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.
For more information on bronchial thermoplasty and the procedure's availability, visit www.BTforAsthma.com.
Based in Sunnyvale, Calif., Asthmatx is a privately-held medical device company that designs, develops and manufactures catheter-based medical devices incorporating thermal energy for patients with severe asthma. Asthmatx's first offering, bronchial thermoplasty delivered by the Alair System, is a novel device-based treatment option for patients with severe asthma. The Alair System has been approved for use in the U.S. by the FDA and has received a CE Mark for use in the European Union. For more information on Asthmatx visit www.asthmatx.com.
Alair, Asthmatx and the Asthmatx logo are registered trademarks of Asthmatx, Inc.
About Virginia Hospital Center
For over 60 years, Virginia Hospital Center has provided exceptional medical services to the Washington metropolitan area. Virginia Hospital Center's $150 million state-of-the-art facility offers comprehensive healthcare and multiple Centers of Excellence including Cardiology & Cardiovascular Surgery, the first NAPBC-accredited Center for Breast Health in Virginia, Neuroscience, Oncology, Total Joint Replacement (hip and knee), Women & Infant Health and Urology. Growing service lines include Executive Health and the only Lung Cancer Center in northern Virginia. Virginia Hospital Center is a teaching hospital, long-associated with Georgetown University's School of Medicine, and accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Licensed by the Commonwealth of Virginia Department of Health. For additional information, please visit www.virginiahospitalcenter.com.
SOURCE Asthmatx, Inc.
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