Back in September, Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center, announced 12-month results of the EMPROVE multicenter, randomized and controlled study for the Spiration® Valve System (SVS), a device used during bronchoscopic lung volume reduction (BLVR), a minimally invasive treatment for severe emphysema, at the European Respiratory Society International Congress (ERS) in Paris, France.
Now, thanks to those positive results, which indicated statistical and clinically meaningful improvements in lung function, target lobe volume reduction, shortness of breath and quality-of-life parameters, the U.S. Food and Drug Administration (FDA) has granted the Spiration® Valve System approval under its breakthrough medical devices designation along with priority review status.
The action marks the second time this year that Temple was the lead enroller for a study that enabled nationwide access to a new and minimally invasive treatment option for emphysema patients.
“This milestone is outstanding news for patients with severe emphysema,” said Dr. Criner, a principal investigator for the EMPROVE study. “It is a wonderful testament to everyone’s hard work and dedication, including those at Temple, that the FDA has approved another minimally invasive option, and in such a short period of time. Patients who have this condition will be able to access yet another new clinical therapy to address their symptoms.”
The EMPROVE trial enrolled 172 patients across 31 centers in the U.S. and Canada and evaluated the safety and effectiveness of the Spiration® Valve System compared to optimal medical care in patients with severe emphysema in a 2-to-1 randomization. Patients eligible for the EMPROVE trial were those with severe airflow obstruction, dyspnea (shortness of breath) and hyperinflation, which occurs when air becomes trapped in the lungs and makes breathing difficult.
The Temple Lung Center was the EMPROVE study’s lead enroller. Dr. Criner presented initial positive results based on a six-month primary endpoint earlier in the year at the American Thoracic Society Annual Conference in San Diegoii The subsequent presentation on Sept. 18 at ERS, one of the largest respiratory meetings of the year, reported on the longer-term 12-month results of the study.
Spiration® Valve System treatment, designed to isolate and reduce volume in the targeted emphysematous lobe, resulted in a mean reduction of 974 milliliters (52.8 percent reduction). As a result of the target lobe volume reduction, the SVS-treated group had a 100 milliliter (12 percent) improvement in FEV1 at six months compared to the control group, an effect that was durable through 12 months. These changes represented statistically significant and clinically meaningful improvement in lung function. FEV1 stands for forced expiratory volume, is a measure of the amount of air a person can forcefully exhale from their lungs in one second and is part of a pulmonary function test.
Additionally, patients treated with the Spiration® Valve showed a statistically significant 33 percent relative improvement in shortness of breath (measured by the mMRC score) in the SVS-treated group compared to the control group.
“The improvement in dyspnea (shortness of breath) reflected by the reduction in the mMRC score is a crucial development for patients with severe emphysema and severe hyperinflation, as it is their most common symptom,” Dr. Criner said. “It marks a key step in treating this long-term, progressive disease.”
The Spiration® Valve is an umbrella-shaped, one-way valve that is placed in the lungs through a flexible bronchoscope during a short procedure and provides surgeons and pulmonologists with a novel method for limiting distal airflow to the damaged or diseased lung.
The system is approved in Europe for the treatment of air leaks and severe, heterogeneous emphysema with evidence of low collateral ventilation such as complete fissures.
The most common procedure-related serious adverse event was pneumothorax (lasting more than seven days) in 12.4 percent of the SVS-treated patients, a complication that is a consequence of effective bronchoscopic lung volume reduction that has previously been demonstrated in patients undergoing endobronchial valve insertion for severe emphysema. COPD exacerbations, pneumonia and death were also observed, but these events were not statistically different between the study groups.
The EMPROVE study was sponsored by Olympus Respiratory America, a part of Olympus Corporation and the developer of the Spiration® Valve System.
“Research like that conducted for the EMPROVE study is invaluable,” Dr. Criner said. “It enables us to find and implement new solutions so that patients can continue to lead lives that are as fulfilling as possible.”
Editor’s Note: Neither Dr. Criner nor any member of his immediate family has financial interest in Olympus Respiratory America or Olympus Corporation.
[i] Criner GJ, Delage A, Voelker KG, for the EMPROVE Trial Investigator Group. Late Breaking Abstract - Endobronchial Valves for Severe Emphysema – 12-month Results of the EMPROVE Trial. European Respiratory Journal, Sep 2018, 52 (suppl 62) OA4928; DOI: 10.1183/13993003.congress-2018.OA4928.
[ii] Criner GJ, Delage A, Voelker KG, for the EMPROVE Trial Investigator Group. The EMPROVE Trial - a Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration® Valve System for Single Lobe Treatment of Severe Emphysema. American Thoracic Society International Conference Abstracts. 2018:A7753-A7753. doi:10.1164/ajrccm-conference.2018.197.1_ MeetingAbstracts.A7753.