University Medical Center Groningen (UMCG) has treated the first patient using its RePneu lung volume reduction coil (LVRC), designed for relieving breathing difficulty in patients with severe emphysema, in RENEW pivotal trial.
The minimally invasive medical implant developed by PneumRx, is made from shape-memory Nitinol and works by compressing hyperinflated tissue to reduce volume and restore lung's natural elastic recoil for improving lung function.
RePneu, which is available in Europe, treats emphysema patients with heterogeneous and homogeneous disease in both upper and lower lobes as well as improves exercise ability and quality of life.
The FDA-approved IDE trial will enroll 315 patients from the US and Europe to compare the safety and efficacy of RePneu with standard medical care in treating symptoms of severe emphysema.
University Medical Center Groningen principal trial investigator Dr Dirk-Jan Slebos said patients have very few options available to relieve symptoms and cure for severe emphysema.
"The LVRC is a very exciting technology that has shown great promise in European clinical studies," Slebos added.
"We have seen significant clinical improvements in treated patients, and we believe this is an important treatment option for many patients with severe emphysema."
The company will use RENEW trial data for submitting a pre market approval application of the RePneu LVRC to the FDA.
In addition, the French Ministry of Health is planning to initiate a multi-center cost-effectiveness study of RePneu in France in early 2013.
