Frequent visitor to our pages, interventional pulmonology company, Pulmonx® tells us it has completed enrollment in the IMPACT prospective, randomized, multi-center study that is the first to examine the benefits of the Zephyr® Endobronchial Valve (EBV) specifically in patients with homogeneous emphysema.
The Zephyr EBV is a tiny, one-way valve placed in the lungs to block airflow to diseased regions in order to achieve lung volume reduction. Zephyr EBVs have been implanted globally in more than 10,000 patients.
It was previously thought that only patients with heterogeneous emphysema, where the disease is isolated to specific areas of the lungs, could benefit from lung volume reduction with endobronchial valves. The IMPACT study was launched based on the promising results of a retrospective analysis of the VENT trial, which indicated that patients with homogeneous disease, where emphysema is diffusely distributed, and little or no collateral ventilation can also benefit from endobronchial lung volume reduction with the Zephyr valve.
The study, which has been taking place in Austria, Germany and the Netherlands, enrolled 93 patients with homogeneous severe emphysema to compare the safety and effectiveness of Zephyr EBV treatment versus medical management. The study uses the company’s proprietary Chartis® System to select patients with little or no collateral ventilation, and advanced imaging technology to select a target lobe for treatment.
“An ever-growing body of evidence supports the benefits of the Zephyr EBV in improving lung function and quality of life for patients,” said Dr. Arschang Valipour, co-principal investigator for the IMPACT study. “Retrospective studies have demonstrated the benefits of the EBV in patients with homogeneous emphysema. The IMPACT study is breaking new ground by prospectively evaluating the benefits of EBV treatment specifically in this homogeneous emphysema patient population, who clearly need additional treatment options.”
“Zephyr valves offer the greatest level of improvement of any minimally invasive procedure for emphysema, and valves are the only removable option,” said Pulmonx Chief Executive Officer Glen French. “Completing enrollment in the IMPACT study is an important milestone as we accumulate scientific evidence for the patient populations that can benefit the most from our treatment.”
Source: Business Wire