US company PneumRx has completed patient enrolment in the REVOLENS study, a cost-effectiveness research programme of the PneumRx RePneu lung volume reduction coil (RePneu LVRC) in France.
RePneu LVRC system is a minimally invasive, which features Nitinol coils, is bronchoscopically implanted into the lungs to improve lung function in emphysema patients, compress diseased tissue (lung volume reduction), restore elastic recoil and adjust lung compliance.
The CE-marked LVRC system also reduces lung volume and restores elastic recoil to improve lung function, exercise capacity and quality of life for patients with emphysema.
In 2012, professors Gaetan Deslee of the University Hospital of Reims and Charles-Hugo Marquette of the University Hospital of Nice submitted the REVOLENS study to the French Ministry of Health, which was accepted and funded by the Ministry of Health under the soutien aux techniques innovantes couteuses (STIC) programme.
The REVOLENS study was one of only two STIC projects selected by the Ministry of Health for funding in 2012.
It is reportedly the first in the field of emphysema treatment since 2006. The French Government has committed to paying $1.8m to support the research programme.
The study began enrolling subjects in March 2013 and was expected to take 12 months to enrol all 100 subjects.
However, enrolment was completed in less than seven months stressing the need for minimally invasive treatment options for patients with severe emphysema.
Professor Marquette said 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," Prof Marquette said.
The CE-Marked RePneu LVRC demonstrated impressive results 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.
PneumRx president and CEO Erin McGurk said: "We look forward to bringing the benefits of the RePneu LVRC to growing numbers of emphysema patients in France and throughout the world."
The RePneu LVRC has been successfully used in more than 1,500 procedures worldwide and is currently undergoing a clinical pivotal trial in the US.