US-based Boston Scientific has obtained Chinese Food and Drug Administration (FDA) approval for its Alair bronchial thermoplasty system, designed for patients suffering from severe asthma.
The Alair system uses mild heat to reduce the excessive smooth muscle tissue in the airways of patients with severe asthma which is not well controlled with inhaled corticosteroids and long-acting beta-agonists.
Bronchial Thermoplasty (BT) is a bronchoscopic procedure typically performed under moderate sedation on an outpatient basis.
Delivered by the Alair System, BT uses mild heat to reduce the excessive smooth muscle tissue in the airways. This reduces airway constriction during an asthma attack, making attacks less frequent and less severe.
Boston Scientific vice president and managing director-China Warren Wang said the company is delighted to see that the Boston Scientific Alair Bronchial Thermoplasty System has been officially certified by the China Food and Drug Administration.
"Unlike conventional treatments, Bronchial Thermoplasty offers a viable new option for patients suffering from severe asthma thanks to its breakthrough technology and mechanism of action.
"We believe this device can markedly improve the quality of life of asthma patients here in China," Wang added.
The clinical data from the Asthma Intervention Research 2 (AIR2) trial, a multi-site, double-blind, sham-controlled study, demonstrated that after undergoing BT treatment, patients reported significant improvement in asthma-related quality of life.
According to the company, the device is expected to be available in the China market later this year.