University Medical Centre Groningen (UMCG) has treated the first patient in an IDE pivotal trial of a minimally invasive lung volume reduction coil designed to relieve breathing difficulty in patients with severe emphysema.
Developed by PneumRx, the RePneu lung volume reduction coil (LVRC) is an implant made from shape-memory Nitinol and works by compressing hyperinflated tissue to reduce volume and restore the lung's natural elastic recoil to improve lung function.
RePneu, which is available in Europe, treats emphysema patients with heterogeneous and homogeneous disease in both upper and lower lobes, while improving exercise ability and quality of life.
The FDA-approved trial, named RENEW, will enrol 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 Centre 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 said.
"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 to support an FDA premarket approval application of the RePneu LVRC.
In addition, the French Ministry of Health is planning to initiate a multi-centre cost-effectiveness study of RePneu in France in early 2013.
Image: Main Entrance of the University Medical Center Groningen. Photo: Courtesy of University Medical Center Groningen.