Uptake Medical has received CE mark approval for its InterVapor System to treat severe emphysema.
The InterVapor System is an endoscopic lung volume reduction system that uses the body’s natural healing processes without leaving foreign materials behind and is designed to directly target the hyperinflation in the lungs.
In addition, the company has released the positive six-month clinical study results of the InterVapor System.
The multi-center, single-arm, open label Vapor study was conducted in patients with upper lobe predominant emphysema.
Primary endpoints measuring lung function improvement (FEV1) and health-related quality of life achieved both statistical and clinical significance at six months.
Additionally, 83 percent of patients met a combined endpoint for clinical improvement.
Secondary endpoints demonstrated that patients treated with the InterVapor procedure have significant physiologic improvements (including decreased hyperinflation and gas trapping) as well as clinical improvements (reduced breathlessness and improved exercise capacity).
Uptake Medical president and CEO King Nelson said they have an opportunity to help patients with severe emphysema and they look forward to have the InterVapor System available to physicians and their patients.