Asthmatx announces first U.S. patient treated with BT delivered by Alair System

May 10 2010

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 Alair® 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."