First Patient Treated for Severe Emphysema with the FDA-Approved Spiration® Valve System

CENTER VALLEY, Pa., March 29, 2019 /PRNewswire/ -- Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the first endobronchial valve treatment of severe emphysema using the FDA-approved Spiration Valve System (SVS). Gerard Criner, MD, Professor and Founding Chair of the Department of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine, Temple University, successfully performed the minimally invasive procedure at Temple University Hospital.

The Spiration Valve is an umbrella-shaped device that is placed in targeted airways of the lung during a short bronchoscopic procedure. Once in place, the SVS redirects air from diseased parts of the lung to healthier parts, allowing the healthier lung tissue to expand and function more effectively.¹ With a potential reduction in lung volume, a patient may be able to breathe more easily and experience improvement in their quality of life.²

"Dyspnea, or shortness of breath, is the most significant limitation that affects an emphysematic patient's quality of life," said Dr. Criner. "When we help alleviate dyspnea, we improve social function and work productivity, not only for patients, but also for their kids, their spouses, and all of those around them."

FDA approval of the SVS was based on results of the EMPROVE clinical trial demonstrating that patients treated with the SVS benefited from statistically significant and clinically meaningful improvements in lung function and quality of life compared to standard of care medical management. The results showed that the SVS offers a favorable risk benefit profile, with a short procedure time.³ Previous clinical study results⁴ have shown that shorter procedure times may reduce the risk of adverse events. Serious adverse events observed in the study included COPD exacerbations, pneumothorax, pneumonia and death.

Emphysema is a progressive form of Chronic Obstructive Pulmonary Disease (COPD) that has affected 3.4 million people in the U.S., according to the Centers for Disease Control and Prevention.⁵  The disease causes a loss of elasticity in lung tissue and enlargement of the alveoli. As a result, emphysematous lobes become hyperinflated, causing shortness of breath. Prominent guidelines^6,7 now recommend bronchoscopic lung volume reduction using endobronchial valves as an alternative treatment option for severe emphysema to more invasive options, such as surgery.

"We are very pleased that doctors are now able to treat patients with the Spiration Valve System," said Lynn Ray, Executive Director of Endotherapy and Respiratory Marketing, Olympus America, Inc. "Emphysema is a very debilitating disease that negatively affects quality of life. Although endobronchial valves are not right for every patient with severe emphysema, the treatment can be life-changing for those who are good candidates."

A decade of clinical studies has shown that patient selection is one of the most important predictive factors of a good response to bronchoscopic lung volume reduction with endobronchial valves.^8,9,10 Patients are selected for this procedure through a screening process that involves a thorough patient evaluation, including examination for any comorbidities, and quantitative CT analysis.

For more information about the SVS, please visit us at http://svs.olympusamerica.com.

About Olympus Medical Systems Group

Olympus is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our nearly 100-year history, Olympus has focused on being true to society and making people's lives healthier, safer and more fulfilling.

Our Medical Business works with health care professionals to combine our innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing with their skills to deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance quality of life for patients. For more information, visit medical.olympusamerica.com. 

¹ Spiration Valve System. 2018. Summary of Safety and Effectiveness.
² Criner GJ, Delage A, Voelker K. Late Breaking Abstract - Endobronchial valves for severe emphysema – 12-month results of the EMPROVE trial. European Respiratory Journal 2018;52: Suppl. 62. doi:10.1183/13993003.congress-2018.OA4928.
³ 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.
⁴ Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014;21(4):288-297.
⁵ Centers for Disease Control. Chronic Obstructive Pulmonary Disease: Basics About COPD. https://www.cdc.gov/nchs/fastats/copd.htm. Accessed March 21, 2019.
⁶ 2019 Global Strategy for the Diagnosis, Management, and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2018. http://goldcopd.org. Accessed January 11, 2019.
⁷ National Institute for Health Care and Excellence. 2017. Endobronchial valve insertion to reduce lung volume in emphysema; Interventional procedures guidance [IPG600]. https://www.nice.org.uk/guidance/ipg600/resources/endobronchial-valve-insertion-to-reduce-lung-volume-in-emphysema-pdf-1899873854992069. Accessed January 11, 2019.
⁸ Sciurba FC, Ernst A, Herth FJF, et al. A randomized study of endobronchial valves for advanced emphysema. New England Journal of Medicine 2010;363(13):1233-1244. doi:10.1056/NEJMoa0900928.
⁹ Schuhmann M, Raffy P, Yi Y, et al. CT predictors of response to endobronchial valve lung reduction treatment: Comparison with Chartis. American Journal of Respiratory and Critical Care Medicine 2015;191(7):767-774. doi:10.1164/rccm.201407-1205OC.
¹⁰ Herth FJF, Slebos DJ, Criner GJ, Shah PL. Endoscopic Lung Volume Reduction: An Expert Panel Recommendation - Update 2017. Respiration 2017;94(4):380-388. doi:10.1159/000479379.

SOURCE Olympus Medical Systems Group

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