Anesthesiology
Review Panel
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- BSDAnalyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling3Product Code
- LSZVentilator, High Frequency3Product Code
- LYMDevice, Cpr AssistUProduct Code
- MNQStimulator, Hypoglossal Nerve, Implanted, Apnea3Product Code
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- OOYBronchial Thermoplasty System3Product Code
- PDRComputer-Assisted Personalized Sedation System3Product Code
- PNCCatheter IntroducerNProduct Code
- POILung Tissue Sealant For Lung Volume ReductionNProduct Code
- PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea3Product Code
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- SDBTracheal Prosthesis With Cover Material Derived From Human Sources2Product Code
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Lung Tissue Sealant For Lung Volume Reduction
- Page Type
- Product Code
- 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
- Submission Type
- Contact ODE
- Device Classification
- N
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
As product code POI is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.