Boston Scientific obtains regulatory clearance for bronchial thermoplasty system in China

24 October 2013 (Last Updated October 24th, 2013 18:30)

Boston Scientific has obtained China Food and Drug Administration approval for its Alair bronchial thermoplasty system, designed to treat severe asthma.

alair

Boston Scientific has obtained China Food and Drug Administration approval for its Alair bronchial thermoplasty system, designed to treat severe asthma.

The Alair system is unique and effective therapy intended for patients whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications.

Bronchial Thermoplasty (BT) is a bronchoscopic procedure typically performed under moderate sedation on an outpatient basis.

BT is delivered by the Alair system that uses mild heat to reduce the amount of excess airway smooth muscle tissue in the airways.

It is designed to decrease the airway's ability to constrict, thereby reducing asthma attack frequency and severity.

Boston Scientific vice-president and managing director-China Warren Wang said: "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."

BT delivered by the Alair system has been proven in clinical trials to be safe and effective.

"We believe this device can markedly improve the quality of life of asthma patients here in China."

The clinical data from the Asthma Intervention Research 2 (AIR2) trial, a five-year multi-site, double-blind, sham-controlled study reported a significant improvement in asthma-related quality of life in patients.

BT has a long-term safety and effectiveness profile. According to the five-year Asthma Intervention Research (AIR) trial, no clinical complications occurred over a five-year period post-BT in patients with moderate to severe asthma.

No radiological findings of clinical significance were observed in high-resolution CT scan. There was also a reduction in respiratory symptoms, emergency room visits and hospitalisations for respiratory symptoms.

According to GlobalData estimates, the respiratory device market in China was valued at $247m in 2012 and is expected to grow at a CAGR of 9.9% to reach $479m by 2019.


Image: The Alair bronchial thermoplasty system. Photo: courtesy of Boston Scientific Corporation.