PneumRx performs over 1500 RePneu LVRC treatments for patients with severe emphysema

Sep 26 2013

PneumRx, Inc., a leader in interventional pulmonology, announced that over 1500 procedures have been performed using the RePneu Lung Volume Reduction Coil (LVRC) System for patients with severe emphysema.

The RePneu LVRC is a minimally invasive device intended to improve lung function, exercise capacity and quality of life in emphysema patients by bronchoscopically implanting Nitinol coils into the lung to compress diseased tissue, restore elastic recoil, and re-tension the airway network. This treatment is a minimally invasive treatment that is effective for a broad range of emphysema patients.

The RePneu LVRC's impressive market adoption is evidenced by the fact that over 1500 RePneu LVRC treatments have been performed, involving over 15,000 Coils, even though the LVRC has been commercially available for just over 2 years.  In addition to being commercially available in Germany, Italy, Switzerland and Turkey, the RePneu LVRC was selected by the French Ministry of Health for, and is currently undergoing, a multi-center cost-effectiveness study in France (STIC), supported by the French Ministry of Health.  Over 75 subjects have been enrolled in the French study, the REVOLENS, since March 2013, and enrollment is expected to be completed, ahead of schedule, before the end of the year.

The RePneu LVRC is rapidly becoming the therapy of choice for emphysema patients in European markets because of its ability to treat a broad range of emphysema patients without requiring any complex diagnostic evaluation. The RePneu Coil does not block airways, prevent distal access, or destroy lung tissue, but instead provides a simple mechanical solution designed both to treat the key physiologic effects of emphysema and to overcome the key challenges of emphysema treatment. As evidenced by the data presented at the recent European Respiratory Society (ERS) meeting in Barcelona, Spain, the RePneu Coil is unique in its ability to treat patients with both heterogeneous and homogeneous emphysema, in both upper and lower lobes, in patients with Residual Volume of 175% predicted and above. In addition, the RePneu LVRC works independently of collateral ventilation, and is performed in a gentle, well-tolerated procedure with a rapid recovery period.

The RePneu Coil is also used extensively in the Netherlands and the UK.  Dr. Dirk-Jan Slebos, of the University Medical Center, Groningen, the Netherlands, has implanted over 1,000 Coils in emphysema patients and is expected to treat 40 subjects this year in the  315-subject, multicenter pivotal study, RENEW, the results of which will be submitted for commercial approval of the RePneu LVRC in the US. Also participating in the RENEW Study is Dr. Pallav Shah of the Royal Brompton and Hareford National Hospital Trust and the Chelsea and Westminster National Hospital Trust in London, U.K. Dr. Shah previously participated in a multi-center, randomized, controlled study of the LVRC in the UK (the RESET Study), the results of which were published this year in The Lancet Respiratory. Among the findings in that study, subjects treated with the RePneu LVRC showed statistically and clinically significant improvements in exercise capacity (6MWT), lung function (FEV1, Residual Volume), and quality of life (SGRQ) as compared to subjects who received best medical care, but no LVRC procedures. In particular, subjects who received treatment with the RePneu LVRC improved an average of over 63 meters in 6MWT as compared to subjects who received best medical care.

This rapid adoption of the RePneu LVRC technology is generating a growing body of data that shows that the RePneu Coil consistently provides safe and effective treatment to a broad range of emphysema patients. Much of this data was presented earlier this month at the ERS. Seven interventional pulmonologists from Germany, France, Italy, the UK and the Netherlands presented study data demonstrating the safety and effectiveness of the RePneu LVRC. In addition, a symposium on the RePneu LVRC technology, featuring presentations by interventional pulmonologists from Germany, France, the Netherlands and Switzerland, generated a significant amount of interest.