Pulmonx® Corporation, purveyor of the Zephyr Endobronchial valve (EBV) for use in emphysema treatment, has now announced the commercial availability of the StratX™ Lung Analysis Platform in countries requiring CE Mark.
It’s a clever idea this. Help the physician to know when to use your product by providing him/her with a diagnostic tool that will predict which patients will respond best, especially if that tool is likely to deliver more patients. It’s a formula that works for the company and for patients who also get to avoid an additional diagnostic procedure. The StratX Platform is designed to help physicians quickly and reliably identify patients for treatment with Zephyr® EBV.
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. The Chartis System is a proprietary assessment system utilized immediately prior to the Zephyr EBV procedure to identify those patients with low or no collateral ventilation, who are the most likely to respond to the treatment. Zephyr EBVs have been implanted globally in more than 12,000 patients and is the most studied minimally-invasive treatment for severe emphysema and is proven to improve patients’ breathing function, exercise capacity and quality of life when patients are properly selected.
Previously, physicians ruled out many patients for EBV treatment based on a subjective review of their lung fissures on computed tomography (CT) scans. This subjectivity left many patients untreated who might have benefitted. In fact, up to 50 percent of emphysema patients who are eligible for some form of intervention may benefit from EBV treatment. Furthermore, before the StratX system, all potential patients had to undergo an additional procedure to evaluate their eligibility.
The StratX service now enables physicians to reliably and efficiently identify patients with complete fissures (above 95 percent complete) who will likely benefit from EBV treatment, and those with incomplete fissures (below 80 percent) who will likely not benefit, reserving additional diagnostic procedures for patients with ambiguous fissure completeness (between 80 to 95 percent complete).
To use the StratX service to pre-screen patients, a physician uses a web browser to securely upload an anonymized CT scan to the cloud. The StratX service then uses validated algorithms to produce a user-friendly report identifying patients as likely responders for EBV treatment and likely non-responders. For patients with partially complete fissures, the CT scan is considered inconclusive and a screening procedure using the Chartis System is recommended.
A study recently published in Respiration showed an accuracy of 90 percent in determining likely responders and non-responders using StratX as a pre-screen and selectively using Chartis for patients with partially complete fissures. This is more accurate than using the StratX technology or Chartis system alone. The retrospective study of 217 US and European EBV-treated patients is the largest study to date using quantitative CT analysis to estimate the expected outcomes of EBV treatment.
StratX™ and the Zephyr® EBV are available for sale in the European Union. The Zephyr® EBV is an investigational device in the United States and limited by U.S. law to investigational use.
“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 Professor 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.”
“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,” said Pulmonx Chief Executive Officer Glen French. “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.”