Study results show the sustained clinical benefits of Spiration Valve System at 24 months

Researchers found ‘statistically significant improvements’ in lung function, respiratory symptoms, and quality of life measures for COPD patients

CENTER VALLEY, Pa., (November 20, 2023) – Olympus announced today study results showing the sustained clinical benefits of the Spiration™ Valve System (SVS) in treating patients suffering from the symptoms of severe emphysema, a form of chronic obstructive pulmonary disease (COPD). Patients treated with the Spiration Valve System experienced a significant improvement in lung function, respiratory symptoms and quality-of-life scores at 24 months, according to published study results.¹

The EMPROVE study is the first randomized controlled trial to present a rigorous comparison of bronchoscopic lung volume reduction (BLVR) using endobronchial valve (EBVs) with standard-of-care controls for up to 24 months in severe emphysema patients.

Researchers measured lung function (using forced expiratory volume in 1 second; FEV1), respiratory symptoms (using the modified Medical Research Council dyspnea scale) and quality-of-life measures using the St. George’s Respiratory Questionnaire, COPD Assessment Test and the Short Form Health Survey. The study results in this longer follow-up time found statistically significant improvements in lung function, dyspnea or shortness of breath, and quality of life in patients treated with the Spiration Valve System, according to the published data.¹

“The results from the EMPROVE trial demonstrate the positive impact the Spiration Valve can have on emphysema patients,” said Dr. Gerard Criner, 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, who is lead investigator of the EMPROVE trial. “SVS treatment offers an important opportunity to improve a patient’s lung function and quality of life. The benefits compared to the control group at 24 months are long lasting, statistically significant and clinically meaningful.”

EMPROVE, a prospective, multicenter, randomized controlled trial, included 172 patients from 31 sites in the United States and Canada. Patients with severe heterogeneous emphysema were randomly assigned treatment with the Spiration™ Valve System or to the control group.^1,4

Researchers found no difference in adverse events between the SVS treatment and control groups, and there were no reported cases of migration or erosion in the SVS treatment group at 24 months.¹

“This study points to the significant and positive long-term impact SVS treatment can have on the day-to-day functions of emphysema patients,” said Dr. John de Csepel, Chief Medical Officer at Olympus Corporation. “Meaningful improvement in breathing can mean fuller lives for patients for activities as simple as the ability to go on daily walks or enjoying time with grandchildren.”

“The data emanating from the EMPROVE trial underscore the clinical advantages that the Spiration Valve holds for patients and illustrate that this BLVR treatment significantly enhances the daily lives of patients,” said Dr. Stephanie Nsiah-Dosu, Respiratory Global Medical Manager for Medical and Scientific Affairs at Olympus Corporation. “As a human biologist, I am excited about the increasing wealth of knowledge we're gaining concerning EBV treatment.”

With 3.23 million deaths in 2019, COPD maintains its rank as the third leading cause of death worldwide.² Emphysema, a progressive type of COPD, affected about two million adults in the U.S. in 2018, as reported by the American Lung Association.³ Emphysema is characterized by a loss of elasticity and enlargement of the air sacs of the lung. The diseased lobes of the lungs become hyperinflated causing significant challenges with breathing.

The Spiration Valve is an umbrella-shaped device that is placed in the most diseased parts of the lung during a short bronchoscopic procedure. Treatment with endobronchial valves such as the Spiration Valve can improve lung function by redirecting air away from hyperinflated portions of the lung to healthier portions.^1,4

Potential adverse events which may be associated with the use of the Spiration Valve System may include, but are not limited to, pneumothorax, worsening of COPD symptoms, pneumonia, and dyspnea. A full list of prescriptive information and additional information on indications, contraindications, warnings, precautions and potential complications is available here.

For more information about the Spiration Valve System, visit the patient and family website.

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About Olympus
As a leading medical technology company, Olympus delivers innovative medical technology, therapeutic intervention, and precision manufacturing used in diagnostic, therapeutic, and minimally invasive procedures. For more information, visit medical.olympusamerica.com.

¹ Criner GJ, Mallea JM, Abu-Hijleh M, et al. Sustained Clinical Benefits of Spiration Valve System in Severe Emphysema Patients: 24-Month Follow-Up of EMPROVE [published online ahead of print, 2023 Nov 10] Ann Am Thorac Soc. 2023;10.1513/AnnalsATS.202306-520OC.

² Chronic obstructive pulmonary disease (COPD.) WHO.int. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd). Updated March 16, 2023. Accessed: November 16, 2023.

³ COPD trends brief - prevalence, COPD Trends Brief. Lung.org. https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-prevalence. Accessed: 16 November 2023.

⁴ Criner GJ, Delage A, Voelker K, et al. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019;200(11):1354-1362.