Lung biopsies naturally puncture the organ, sometime leading to a pneumothorax (collapsed lung) – a potentially life-threatening complication.
The FDA has just cleared the Bio-Seal Lung Biopsy Tract Plug System from Angiotech, which allows physicians to apply a special hydrogel plug to the needle entrance site and block air from exiting through the hole. The hydrogel expands after coming in contact with body liquids after imlantation. After some time it is slowly resorbed by the body and so does not have to be removed in a follow up procedure.
Features from the product page:
- Bio-Seal™ is a single use disposable system intended for the prevention of pneumothorax following percutaneous lung biopsy.
- The patented hydrogel plug resorbs into the patient’s body after healing of the puncture site has occurred.
- Each Bio-Seal™ system features two sets of plugs and co-axial adaptors to accommodate multiple lung biopsy sites.
- Angiotech™ offers a broad range of 19G introducers designed for compatibility with the Bio-Seal™plug adaptor. These introducers maybe used in conjunction with any 20G or 22G biopsy device.
Link to animation showing how the Bio-Seal plug is inserted…
FDA news release: FDA permits marketing of device to seal lung punctures
Product page: Bio-Seal
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