View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
October 24, 2013

Boston Scientific obtains regulatory clearance for bronchial thermoplasty system in China

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

By admin-demo

alair

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

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

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.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network