This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Spiration® Valve System
PMA Applicant: Spiration, Inc.
Address: 6675 185th Avenue, Redmond, Washington 98052
Approval Date: December 3, 2018
Approval Letter: Approval Letter
What is it? The Spiration Valve System is an implantable bronchial valve and delivery system used to reduce over inflation of the lungs due to severe emphysema in adults. The umbrella shaped one -way valve is placed in the targeted airway using a minimally invasive procedure. The valve is comprised of a flexible nickel-titanium (Nitinol) frame that supports a polymer membrane, with anchors to hold the valve in place. The Spiration Valve is designed to be a permanent implant, but can be removed if necessary using the removal rod.
How does it work? Using a flexible bronchoscope, a doctor implants the Spiration Valve into diseased areas of the lung. The valve is a one-way device, which means that when a patient breathes in the valve closes and blocks airflow to areas of the lung with emphysema. Breathing out allows trapped air to flow around the valves and out of the lungs. These valve effects may redirect airflow to healthier areas of the lungs, and reduce shortness of breath.
When is it used? The Spiration Valve System is indicated for the treatment of adult patients whose lungs are overinflated by trapped air due to severe emphysema and who are not feeling better despite drugs, pulmonary rehabilitation, and oxygen therapy.
What will it accomplish? In a clinical study of 172 patients with severe emphysema, 113 patients received the Spiration Valve System and 59 patients received medical management only. Results of the study showed that the patients who received the SpirationValve demonstrated improvements in in pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation).
When should it not be used? The Spiration Valve System should not be used in patients who:
- have not quit smoking,
- have a known or suspected sensitivity or allergy to nickel,
- have an active pulmonary infection,
- have a large bullae (air pocket) encompassing greater than 30% of either lung,
- have diffuse homogeneous emphysema,
- are unable to tolerate bronchoscopy procedures.
Additional information (including warnings, precautions, and adverse events):