The RENEW study — a pivotal US randomized controlled clinical trial analyzing the safety and efficacy of the PneumRx endobronchial coil implant (EBCI) for patients with severe emphysema — met all primary and secondary endpoints, according to BTG.
The PneumRx Endobronchial Coil Implant is a shape-memory nitinol coil implanted in the sub-segmental airways of the lung in patients with severe emphysema via a minimally invasive bronchoscopic procedure.
Patients treated with the PneumRx EBCI showed a statistically significant 33-foot (10.2 m) benefit compared to control patients in the six minute walk test (6MWT) at 12 months, which was the study primary endpoint.
Importantly, patients treated with the PneumRx EBCI exhibited statistically significant and clinically meaningful improvements versus control patients at 12 months in Quality of Life measured by Saint George Respiratory Questionnaire and lung function measured by FEV1.
Serious adverse events in the treatment and control groups were as expected in a patient population of mostly GOLD IV patients. Events associated with bronchoscopy and EBCI placement such as pneumothorax, lower respiratory tract infections, respiratory failure, haemoptysis, COPD exacerbation, and dyspnoea occurred, as anticipated, at a higher rate in the treatment arm.
“We are delighted with the successful outcome of RENEW, showing significant benefit in patients treated with the PneumRx Coils in one of the largest randomised controlled clinical trials of a medical device in patients with severe emphysema to date incorporating both patient reported and objective outcomes,” said Louise Makin, CEO of BTG. “We will now progress our regulatory application in the US, which we anticipate submitting around mid-2016.”