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BioSentry® Tract Sealant System

PLUG. PREVENT. PROTECT.

BioSentry Tract Sealant System is the first biopsy sealant system of its kind designed specifically to address the issues of biopsy-related pneumothorax.

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    Feature & Benefits

    The BioSentry Tract Sealant System deploys a self-expanding hydrogel plug into the pleural space following a percutaneous lung biopsy. This creates an airtight seal that closes the pleural puncture and provides accuracy in marking a biopsy location for visualization during surgical resection.

    • Hydrogel plug fully resorbs†
    • During this time it is visible and marks the biopsy location for surgery
    • The applicator standardizes the method how the plug is placed1
    • Usable with 17 G & 19 G coaxial introducer needles
    • No clinically significant complications associated with use²

     

    Image of dehydrated plug inserted into pleural space

    Dehydrated plug is deployed with 0.5 cm
    extending into the pleural space

    Image of hydrogel plug swelling, creating airtight seal

    Plug swells, creating an airtight seal
    that closes the pleural puncture

    CLINICAL STUDIES

     

    MD Anderson Cancer Center denotes a 61% reduction in chest tubes1

    Image shows a bar chart with BioSentry in red at 8.2% and Standard of Care in charcoal at 20.8% of patients needing chest tubesHIGHLIGHTS

    • 37% reduction of pneumothorax and 61% reduction of chest tube placement
    • Although the BioSentry System was more frequently used in high-risk patients in the unmatched group, it still demonstrated reduced risk of pneumothorax
    • Use of BioSentry System presents a standardized method for mitigating complications post CT-guided lung biopsy for clinicians

    ARR = Absolute Risk Reduction; RRR = Relative Risk Reduction

    STUDY DESIGN

    Retrospective study, comparing patients receiving BioSentry device (318) vs. control arm (1956) during percutaneous lung biopsy. To adjust for potential selection bias, patients in the treated group were matched 1:1 to patients in the control group using propensity score matching.

     

    All-comers study demonstrates 80% reduction in chest tube insertion rates when using the BioSentry System2

    Image shows a bar chart with BioSentry in red at 2.0% and Standard of Care in charcoal at 10.0% of patients needing chest tubesHIGHLIGHTS

    • The treatment group demonstrated a significant reduction in chest tube placements
    • With the BioSentry System, patients experienced an 83% reduction in average time of hospital stay post CT-guided percutaneous transthoracic needle biopsy

    STUDY DESIGN

    Retrospective review of 200 consecutive patients (100 consecutive biopsies were done without any intervention and the next 100 consecutive biopsies done with the BioSentry System).

    † Data on File

    REFERENCES
    1 Ahrar JU, Gupta S, Ensor JE et al. Efficacy of a Self-expanding Tract Sealant Device in the Reduction of Pneumothorax and Chest Tube Placement Rates After Percutaneous Lung Biopsy: A Matched Controlled Study Using Propensity Score Analysis. Cardiovasc Intervent Radiol. 2017; Feb 40(2):270-276. doi: 10.1007/s00270-016-1489-9.
    2 Grage RA, Naveed MA, MD, Keogh S, Wang D. Efficacy of a Dehydrated Hydrogel Plug to Reduce Complications Associated With Computed Tomography–guided Percutaneous Transthoracic Needle Biopsy. J Thorac Imaging. 2017; Jan 32(1):57-62, doi: 10.1097/RTI.0000000000000247.

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    407036001_001 ID 101123