PneumRx initiates RePneu LVRC pivotal study in severe emphysema

PneumRx, Inc., a leader in interventional pulmonology, announced  the first U.S. patients treated with PneumRx's Lung Volume Reduction Coils (LVRCs) for severe emphysema.  Dr. Charlie Strange , of the Medical University of South Carolina, and Dr. Frank Sciurba , of the University of Pittsburgh and UPMC, treated the first US patients in the FDA-approved RENEW Study.  The RePneu® LVRC, a minimally invasive medical implant designed to treat the symptoms of severe emphysema, is intended to improve lung function, exercise ability and quality of life for this underserved patient population.

Dr. Sciurba stated that "There is no cure for severe emphysema, and patients have very few options available to relieve their symptoms.  I believe the LVRC is a potentially life-changing treatment option for many patients with severe emphysema."  Dr. Strange, the Principal Investigator for the RENEW Study, added "Having attended LVRC procedures in Europe and seen the benefits of this innovative treatment for emphysema patients, I am thrilled to be able to offer our patients the option of participating in the RENEW Study." 

Although the LVRC is undergoing clinical evaluation in the United States, it has been used in Europe since 2008.  The technology is routinely available to treat patients in Germany, and was the only emphysema treatment method selected in 2012 by the French Ministry of Health to undergo a multi-center cost-effectiveness study in France.  Unlike Lung Volume Reduction Surgery or other minimally invasive devices designed to treat emphysema, the RePneu LVRC 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 began enrolling patients in the European sites, which are experienced in the technique, late last year.  Up to 315 patients in over 25 medical centers across North America, plus centers in the Netherlands, UK and Germany, will participate in the RENEW Study.  "Bringing relief to the millions of emphysema sufferers was a significant motivation in founding PneumRx, so it is particularly meaningful to me that we have begun treating people with this debilitating disease here at home.  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 U.S." stated Erin McGurk , President and CEO of PneumRx.

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.

Although the RePneu LVRC is investigational in the United States and not yet approved for commercial use by the FDA, the device has a CE Mark and has been used in Europe for the treatment of severe emphysema since 2008.