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U.S. Department of Health and Human Services

Product Classification

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Device lung tissue sealant for lung volume reduction
Definition The system is intended to reduce lung volume irreversibly by employing a synthetic polymer to seal airways in order to improve lung function and quality of life in patients with advanced emphysema. It functions by physically occluding both small airways and collateral air channels through sealing lung tissue, causing the treated area to collapse via absorption atelectasis. It is a single use device intended to be used by pulmonologists and thoracic surgeons in a bronchoscopy suite or operating room.
Physical State The foam is prepared immediately prior to administration using a standard accessory (stopcock) and mixing together the following: • Solution A (4.5 mL of solution containing 2.1% (w/v) of aminated polyvinyl alcohol [aPVA]) • Solution B (0.5 mL of solution containing 1.25% (w/v) of glutaraldehyde [GA]) • 15 mL of air Polymerization is initiated as the two solutions are mixed in the 20 mL Syringe. The GA molecules covalently bond to the aPVA molecules. Room air is introduced via a standard accessory (30 mL syringe) and the mixture is foamed by pushing the solutions and air through a stopcock between the 20 mL Syringe and the 30 mL syringe for 10 cycles.
Technical Method The AeriSeal System is designed to produce lung volume reduction by physically occluding airways, leading to reduced gas trapping in order to improve lung function and quality of life in patients with advanced emphysema. A single subsegmental treatment consists of an injection of up to 20 mL of foam administered through a standard fiberoptic bronchoscope via a standard accessory (20 mL Syringe) and the catheter, followed by administration of up to 30 mL of air through the instrument channel of the scope, into the treated area of damaged lung.
Target Area Small airways and collateral air channels of the lung
Review Panel Anesthesiology
Product CodePOI
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible