Pulmonx recently announced that its StratX Lung Analysis Platform is commercially available in countries requiring CE mark (Conformité Européne, a mark that proves a product complies with the essential requirements of European legislation).
The StratX Platform was created to help physicians quickly and accurately identify patients eligible for treatment with Zephyr Endobronchial Valves (EBV) – a small, one-way valve placed in the lungs to block airflow to ailing regions to reduce lung volume. EBV is a minimally invasive treatment for severe emphysema.
The Zephyr EBV procedure uses the Chartis System to identify patients with low or no collateral ventilation who are most likely to respond to treatment. According to the company, Zephyr EBV is proven to improve patients’ breathing function, exercise capacity, and quality of life.
With StratX, a physician can securely upload an anonymized computer tomography (CT) scan to a cloud-based platform. StratX then uses validated algorithms to produce a user-friendly report identifying patients as likely responders of EBV treatment — patients with complete fissures (divisions between the lobes above 95 percent complete) and non-responders (patients with incomplete fissures below 80 percent). For patients with partially complete fissures (between 80 and 95 percent), a screening procedure using the Chartis System is recommended.
Until now, the decision to include patients in EBV treatment was subjective and based on CT scans. Pulmonx believes that up to 50 percent of emphysema patients who are eligible for some form of intervention may potentially benefit from EBV treatment.
“Emphysema patients with few therapeutic options who could benefit from EBV are unnecessarily excluded from treatment due to the imprecision of visual CT review or QCT-only screening,” Pulmonx CEO Glen French said in a press release. “A combined approach using StratX and Chartis will enable more patients to benefit from what has been shown to be the best minimally invasive treatment available today.”
A recent study titled “Predicting Lung Volume Reduction after Endobronchial Valve Therapy Is Maximized Using a Combination of Diagnostic Tools,” published in the journal Respiration, showed that StratX showed a 90 percent accuracy rate in determining likely responders and non-responders, as well as in selectively using Chartis for patients with partially complete fissures. This study of 217 U.S. and European EBV-treated patients is the largest to date using quantitative CT analysis to estimate the expected outcomes of EBV treatment.
“The Zephyr EBV should be considered a first-line treatment for properly selected patients with severe emphysema based on its robust clinical evidence, minimally invasive approach and reversibility. However, despite its proven effectiveness, it has been time intensive to identify the right patients for treatment,” said Prof. Felix Herth, MD, of the Thoraxklinik at the University of Heidelberg. “The StratX service provides measurements that will make it easier to identify the patients most likely to benefit from EBV treatment.”
Pulmonx is an interventional pulmonology company that develops technologies to improve the lives of lung disease patients worldwide. It is based in Redwood City, California, and Neuchâtel, Switzerland.