Tiny Valves that Help Patients with Severe Emphysema
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.
Spiration valves are indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
“Performing the first procedure post-FDA approval is a critical moment in our continual efforts to expand the treatment options available to Temple Lung Center patients,” said Dr. Criner. “We are pleased to be able to offer this minimally invasive endobronchial treatment to patients with severe emphysema and severe hyperinflation.”
The Clinical Trial that Paved the Way to this New Treatment
Last September, Dr. Criner announced 12-month results of the EMPROVE multicenter, randomized and controlled study for the Spiration Valve System (SVS)i at the European Respiratory Society International Congress (ERS) in Paris, France. Thanks to those positive results, which indicated statistically significant and clinically meaningful improvements in lung function, target lobe volume reduction, shortness of breath and quality-of-life parameters, the FDA granted the Spiration Valve System approval in December 2018 under its breakthrough medical devices designation along with priority review status.
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 2018 at the American Thoracic Society Annual Conference in San Diego.ii 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.
Study Results Mean Patients Breathe Better
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, an abbreviation 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 an important part of a pulmonary function test.