Ministère en charge de la santé French Government Agrees to Fund Study of the PneumRx RePneu Lung Volume Reduction Coil. 2012 The REVOLENS project.
The French Ministry of Health has approved a cost-effectiveness study of the RePneu Lung Volume Reduction Coil (RePneu LVRC) in France. The Ministry of Health agreed to fund the study under the soutien aux techniques innovantes couteuses (STIC) program, which provides government funding for innovative medical technologies that have been validated by prior clinical studies, with a view toward establishing reimbursement for new devices.
The PneumRx study is one of only two STIC projects selected by the Ministry of Health for funding in 2012, and the first in the field of emphysema treatment since 2006. The protocol, entitled "Evaluation Medico-Economique de la Reduction Volumique par Voie Endobronchique au Moyen de Spirales (REVOLENS)" (Medico-Economic Evaluation of Endobronchial Volume Reduction Using Coils), was submitted by Professors Gaetan Deslee of the University Hospital of Reims and Charles-Hugo Marquette of the University Hospital of Nice and is scheduled to begin enrolling patients in France in January, 2013.
The RePneu LVRC System is a minimally invasive device intended to improve lung function in emphysema patients by bronchoscopically implanting Nitinol coils into the lungs to compress diseased tissue (lung volume reduction), restore elastic recoil, and adjust lung compliance. This treatment offers a minimally invasive alternative to lung volume reduction surgery to a broad range of emphysema patients.
The RePneu LVRC has already undergone extensive clinical studies in Europe, with impressive results in over 250 treatments. The majority of subjects who underwent RePneu LVRC treatment in PneumRx's European clinical trials experienced significant improvement in lung function, exercise capacity and quality of life at both 6 months and one year after treatment, with minimal risk. 74% of all clinical subjects maintained a clinically significant improvement in exercise capacity at 12 months post-treatment and 96% experienced significant improvement in quality of life. The RePneu LVRC received the CE Mark in October 2010 and is commercially available in select countries in Europe. PneumRx has also received approval from the FDA to commence a 315-subject pivotal trial in the United States.