MOUNTAIN VIEW, Calif., Oct. 28, 2013 /PRNewswire/ -- PneumRx, Inc. (www.pneumrx.com), a leader in the field of interventional pulmonology, today announced that enrollment in the REVOLENS Study, a cost-effectiveness study of the PneumRx RePneu Lung Volume Reduction Coil (RePneu LVRC) in France, has been completed. The REVOLENS study was submitted last year to the French Ministry of Health by Professors Gaetan Deslee of the University Hospital of Reims and Charles-Hugo Marquette of the University Hospital of Nice and was accepted and funded by the Ministry of Health under the soutien aux techniques innovantes couteuses (STIC) program. The STIC program provides government funding for innovative medical technologies that have been validated by prior clinical studies, with a view toward establishing reimbursement for new devices.
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It was anticipated that the study, which began enrolling subjects in March 2013, would take 12 months to enroll all 100 subjects. Instead, enrollment was completed in less than 7 months. This rapid enrollment, which is rare among STIC trials, underscores the need for, and interest in, innovative, minimally invasive treatment options for patients with severe emphysema.
"Having seen the improvements in lung function, exercise capacity and quality of life experienced by the patients we treated in previous trials with the RePneu Coil, we were excited to bring this innovative technology to additional patients via the STIC program. The patient interest in this trial has been overwhelming," said Professor Gaetan Deslee, Principal Investigator for the study. "Such a quick enrolment was possible only because of a large commitment of all French teams involved in the treatment of severe COPD patients. The RePneu LVRC represents an important advancement in the treatment of patients with severe COPD and emphysema, and we look forward to being able to offer the RePneu Lung Volume Reduction as a therapeutic option in the future," said Professor Charles-Hugo Marquette.
The REVOLENS study was 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 French Government committed to pay 1.3 Million Euros ($1.8 Million) to support this study.
The RePneu LVRC System 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 lungs to compress diseased tissue, restore elastic recoil, and re-tension the airway network. The RePneu LVRC treatment has proven to be effective for 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. The RePneu LVRC has proven effective in treating patients with both heterogeneous and homogeneous emphysema, in both upper and lower lobes, and 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 LVRC, which is undergoing a clinical pivotal trial in the United States, has a CE Mark and has been used in over 1500 procedures worldwide, even though the device has been commercially available in Europe for just over 2 years.
"We are thrilled that the French government recognized the benefits of the RePneu Coil and agreed to support this important study," noted Erin McGurk, PneumRx's President and CEO. "We look forward to bringing the benefits of the RePneu LVRC to growing numbers of emphysema patients in France and throughout the world."
