PneumRx has treated the first US patient in a clinical study of its minimally invasive medical implant for the treatment of patients with severe emphysema, including those with heterogeneous and homogeneous disease in both upper and lower lobes.
The CE-marked implant, RePneu lung volume reduction coil (LVRC), is made from shape-memory Nitinol and is designed to compress hyperinflated tissue and tether small airways to prevent airway collapse without blocking or inducing fibrosis.
The implant also reduces lung volume and restores elastic recoil to improve lung function, exercise capacity and quality of life for patients with emphysema, according to the company.
The FDA-approved RENEW study, which began enrolling patients at European sites in late 2012, will enrol 315 patients in over 25 medical centres across North America.
Medical University of South Carolina LAM clinic co-director and trial principal investigator Dr Charlie Strange said; "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."
PneumRx president and CEO Erin McGurk said; "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 US."
In addition, the French Ministry of Health has selected RePneu to commence a multi-centre cost-effectiveness study in France.
The company said that the RePneu LVRC is investigational device in the US and is not yet approved for commercial use by the FDA.