The first US patients were treated for severe emphysema using PneumRx’s Link no longer available, according to the company. The treatments were part of the FDA-approved RENEW Pivotal Study.
The LVRC is an implantable device intended to improve lung function in patients with emphysema by achieving a lung volume reduction using minimally invasive means. It is intended to treat a broad range of emphysema patients, including those with heterogeneous and homogeneous disease, in both upper and lower lobes, and it performs independently of collateral ventilation, a common condition in emphysema patients.
The RENEW Study enrolled up to 315 patients in over 25 medical centers across North America, plus centers in the Netherlands, UK and Germany. Qualifying patients must have been clinically diagnosed with severe emphysema and be experiencing increasing difficulty with simple daily tasks. Patients must have stopped smoking for at least eight weeks and must have completed a pulmonary rehabilitation program prior to enrollment.
“There is no cure for severe emphysema, and patients have very few options available to relieve their symptoms,” said Frank Sciurba, MD, of the University of Pittsburgh and UPMC. “I believe the LVRC is a potentially life-changing treatment option for many patients with severe emphysema.”