Pulmonx Inc. engages in designing, developing, manufacturing, and marketing minimally-invasive medical devices and technologies for the diagnosis and treatment of pulmonary disorders. It offers Chartis Pulmonary Assessment System, which helps pulmonologists with lobe-specific information about a patient’s lung, and enables them to plan valve treatments to account for anatomical variations in the lungs of individual patients; and Zephyr Endobronchial Valve (EBV), a diagnostic and therapeutic solution to predict and achieve reduction of volume in the diseased portion of the lung without the risks and complications of surgery. The company’s products are used to deliver endoscopic lung volume re...
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Founded in 1998
Pulmonx Corporation Announces One-Year Results from the STELVIO Trial
May 18 16
Pulmonx Corporation announced positive one-year results from the groundbreaking STELVIO trial. The STELVIO trial is the first randomized controlled study of Zephyr® Endobronchial Valves (EBV) in severe emphysema patients selected using the Chartis® System. EBV-treated patients showed durable improvements in lung function, exercise capacity and quality of life at one year. The results were presented at the American Thoracic Society (ATS) Annual Meeting by the lead author, Karin Klooster, PhD of the University Medical Center Groningen, The Netherlands. Of the EBV-treated patients in the STELVIO trial evaluated at one year, 65% showed a clinically meaningful improvement in lung function (FEV1) at 12 months compared with 72% at six months. Similarly, at 12 months, 75% of EBV-treated patients showed a clinically meaningful improvement in distance on the Six Minute Walk Test compared to 77 % at six months. The improvement in FEV1 was +17% and in distance on the Six Minute Walk Test was +61 meters. No late pneumothoraces occurred. The one-year analysis of the STELVIO trial included 40 severe emphysema patients previously confirmed with the Chartis System to be likely responders to Zephyr EBV therapy due to the absence of interlobar collateral ventilation, who volunteered to be evaluated at one year. Tiny one-way valves were placed in select airways of patients to block airflow to diseased regions of the lung, with the goal of improving their breathing. The study also included patients that were crossed over from the medical management arm to the EBV treatment arm. The STELVIO trial was led by Dirk-Jan Slebos, MD, PhD, pulmonologist, and Dr. Klooster, study coordinator, of the Department of Pulmonary Diseases and the Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, The Netherlands. The trial was funded by a Dutch government grant from ZonMW and the University Medical Center Groningen, The Netherlands, and was performed independently of Pulmonx. The STELVIO trial is the first randomized, controlled trial of Zephyr EBV therapy using the Chartis System to identify patients most likely to benefit. It is also the first prospective trial to demonstrate that Zephyr EBV therapy can benefit patients regardless of heterogeneous or homogeneous distribution of the disease. The Zephyr EBV is a minimally-invasive treatment for severe emphysema that has been proven in over a decade of clinical experience to significantly improve the lung function, exercise tolerance and quality of life for patients receiving treatment. The Chartis System is utilized prior to the procedure to identify likely responders. In the procedure, tiny, one-way valves are placed in the lungs to block airflow to diseased regions to achieve lung volume reduction. As a result, the remaining healthy regions may function more efficiently, enabling better breathing and an improved quality of life for patients who can then perform more activities of daily life. Zephyr EBVs have been implanted globally in more than 10,000 patients.
Pulmonx Announces the Launch of Tablet Version of Chartis Pulmonary Assessment System
Sep 28 15
Pulmonx announced the launch of a tablet version of its Chartis Pulmonary Assessment System, a diagnostic tool designed to identify optimal patients for Zephyr® Endobronchial Valve (EBV) therapy. The Chartis Tablet is portable, has a small footprint and is designed to be easier for physicians to use during pre-procedural evaluation. The new tablet will be showcased at the European Respiratory Society International Congress (ERS) this week in Amsterdam. It will also be commercially available immediately in Europe, where the Zephyr EBV and Chartis System have received the CE Mark. The Chartis System is a proprietary endoscopic, catheter-based diagnostic system that identifies collateral ventilation by enabling precise and real-time assessment of flow and pressure readings for specific lobes in the lungs. This critical information allows physicians to select those patients with no or low collateral ventilation for Zephyr EBV treatment, and helps them predict with high accuracy those patients that are most likely to benefit from the therapy. Multiple randomized controlled trials have demonstrated that patients selected using the Chartis System and treated with the Zephyr EBV have experienced statistically significant improvements in lung function, exercise capacity and quality of life. More than 65% of severe emphysema patients have been shown to have low collateral ventilation in one or more target lobes of the lung, demonstrating a large potential market for the Zephyr EBV treatment. 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. With Chartis capabilities in a tablet, physicians can now place the system in a convenient location that allows them to visually focus on the procedure, ensuring the diagnostic is run as intended and that patient selection for the EBV procedure is as accurate as possible. The tablet has a high resolution touch screen and is Bluetooth-enabled for ease of use. It also includes an HDMI-out that enables picture-in-picture capabilities. The Chartis assessment can be performed during spontaneous breathing or mechanical ventilation (including jet ventilation) under general anesthesia.