New study demonstrates benefits of Olympus Spiration® Valve System in severe emphysema
REACH Study assesses the safety and effectiveness of the Spiration Valve System endobronchial therapy for severe emphysema
The first multicentre study from Olympus comparing endobronchial valve therapy to a medical arm control has met its primary effectiveness end point. The study has also demonstrated sustained clinically meaningful benefits showing acceptable adverse events in patients with severe emphysema selected by high resolution computed tomography (HRCT).
Announced as a late breaking abstract, the results of this study were presented at the 26th International Congress of the European Respiratory Society (ERS) in London in September 2016.
What is the Spiration Valve System?
The Spiration Valve is an umbrella-shaped device introduced in the lungs through the working channel of a flexible bronchoscope. It was developed to achieve lobar volume reduction and relieve hyperinflation in patients with severe emphysema without the risks of mortality and morbidity associated with surgical procedures. Its unique design minimises contact with the bronchial wall, maintains position with zero percent expectoration, and facilitates removal when needed.
As one of the Australian pioneers in the use of endobronchial valves in patients with emphysema, Alvin Ing, Clinical Professor Faculty of Medicine and Health Sciences at Macquarie University highlighted the importance of this study by saying, “It is the first randomised controlled trial involving Spiration valves and it shows clinically significant benefit, not just statistically significant results.”
This multicentre study enrolled 101 subjects, 66 randomised to treatment and 35 to the control. The patients enrolled in the study had to meet careful selection criteria including lung function, degree of hyperinflation and exercise capacity. Their lungs were further assessed using HRCT scans to evaluate emphysema severity and identify a target lobe suitable for treatment with Spiration Valves.
Treatment comprised complete occlusion of a target lobe utilising the Spiration Valve System from Olympus, while the control group received optimal medical management. Compared to control, the treatment group achieved a significant and clinically meaningful improvement in lung function test as measured by FEV1 at the one, three, and six month visits.
The study also showed that responder rate, as evidenced by target lobe volume reduction, was 66.7 percent at six months in the treatment group. Significant improvements were also observed for quality of life measures and exercise capacity.
Professor Felix Herth, Chairman and Head of Department of Pulmonology and Critical Care Medicine at Thoraxklinik, Heidelberg University Hospital, is a global authority on this treatment and also emphasised the significance of this study.
“The REACH trial confirmed clearly that proper patient selection is the key for a successful endoscopic lung volume procedure with valves. In this RCT, multiple endpoints were reached with a low complication rate,” he said.
About the Spiration Valve System
The Spiration Valve System is intended to treat severely diseased lung in patients with emphysema or damaged lung resulting in air leaks by limiting airflow to selected areas. In Australia, the Spiration Valve System is TGA approved for these indications.
In the United States, it is the only device that is authorised by Federal law for use in the control of prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or Lung Volume Reduction Surgery (LVRS). The effectiveness of this device for this use has not been demonstrated. Federal law restricts this device to sale by or on the order of a physician.