Uptake Medical has received Australian Therapeutic Goods Administration (TGA) approval for its InterVapor system, designed for endoscopic lung volume reduction as a treatment for patients with severe emphysema.
The InterVapor system is a non-surgical procedure that uses the body's natural healing processes without leaving foreign materials behind to directly target the hyperinflation in the lungs.
The approval is backed by the multi-centre open label single-arm VAPOR trial, which showed a reduction in lung volume as well as improvement in lung function and health-related quality of life at six months.
A six-month study conducted in patients with upper lobe predominant emphysema demonstrated that the InterVapor system demonstrated improvements in breathing capacity, shortness of breath, exercise capacity and quality of life.
In the VAPOR study, patients achieved the primary endpoints related to measuring lung function improvement and health-related quality of life.
Secondary endpoints for physiologic improvements (including decreased hyperinflation and gas trapping) and clinical improvements (including reduced breathlessness and improved exercise capacity) were also achieved.
Gregory Snell, head of lung transplant services at Alfred Hospital in Melbourne, Australia, said that the InterVapor system has continued to demonstrate clinical efficacy and safety, and that he looked forward to offering InterVapor to the patients.
"Our involvement with Uptake Medical and InterVapor goes back to the first usage in patients, and we are delighted to see the TGA approval," Snell said.
VAPOR trial investigator Peter Hopkins said that being able to provide InterVapor to patients represents an important step in further enhancing the standard of care for the treatment of severe emphysema.
Uptake Medical president and CEO King Nelson said that the company looks forward to working with its distributor partner, Aurora BioScience, to introduce InterVapor in Australia 2012.
The InterVapor system has also received CE mark approval in September 2011.
Uptake Medical is focused on the development and commercialisation of innovative, non-surgical treatments for lung diseases.