PneumRx has treated the first US patient in a FDA-approved RENEW clinical study of its RePneu lung volume reduction coil (LVRC), designed to treat severe emphysema.
Made from shape-memory Nitinol, the CE-marked minimally invasive medical implant works by compressing the hyperinflated lung tissue to reduce volume, while helping to restore the lung’s natural elastic recoil in patients with severe emphysema, including those with heterogeneous and homogeneous disease in both upper and lower lobes.
In addition, the device improves lung function, exercise capacity and quality of life for patients with emphysema, according to the company.
The study, which began enrolling patients at European sites in late 2012, will recruit 315 patients in over 25 medical centers across North America.
PneumRx president and CEO Erin McGurk said; "We look forward to submitting the pivotal trial results in support of a PMA application and eventually offering the benefits of LVRC treatment to patients throughout the US."
In addition, the French Ministry of Health has chosen PneumRx’s RePneu to initiate a multi-center cost-effectiveness study in France.
The company said that the RePneu LVRC is an investigational device in the US and is not yet approved for commercial use by the FDA.