PneumRx gain FDA approval to begin RePneu LVRC system pivotal trial
PneumRx has received US Food and Drug Administration approval to initiate a 30-site pivotal clinical trial to support a premarket approval (PMA) application for the RePneu lung volume reduction coil (LVRC) system.
The RePneu LVRC system is a minimally invasive device designed to improve lung function in emphysema patients by bronchoscopically implanting Nitinol coils into the lungs to compress diseased tissue, restore elastic recoil and adjust lung compliance.
Patients treated with RePneu LVRC system in the European clinical trials demonstrated considerable improvement in lung function, exercise capacity and quality of life at both six months and one year after treatment, with minimal risk.
In the studies, 74% of the subjects maintained a clinically significant improvement in exercise capacity at 12 months post-treatment and 96% showed improvement in quality of life.
The subjects treated with RePneu LVRC also reported a mean improvement in the six-minute walk test of 62 metres, a 12% increase in FEV1, a 10% decrease in residual volume and a decrease of 12 points in the St. George's Respiratory Questionnaire, at 12 months.
The RePneu LVRC has also been proven effective in patients with both heterogeneous and homogeneous disease, in both the upper and lower lobes.
PneumRx president and CEO Erin McGurk said the company plans to treat over 300 subjects in the pivotal trial and expects to start enrolling clinical subjects in the coming months.
"We look forward to submitting the pivotal trial results in support of a PMA application to sell the RePneu LVRC system in the United States," McGurk added.
In October 2010, the European Commission approved PneumRx's RePneu LVRC system.
PneumRx is focused on the development and commercialisation of innovative products to treat emphysema using minimally invasive techniques.