đź“Š Evidence-Based Reference
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Abbott Medical
Summary: The peel-away introducer by Abbott Medical is a device used for minimally invasive procedures, primarily in neurosurgery and pleuroscopy. Key evidence highlights its utility in reducing procedural trauma and facilitating access in complex anatomical areas.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K230283 ↗
Decision Date ?
March 1, 2023
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The peel-away introducer received FDA clearance through the 510(k) pathway on March 1, 2023. It is manufactured by Abbott Medical and classified as a Class 2 device under product code DYB.
What It Is
The peel-away introducer is a medical device designed to facilitate the insertion of catheters or other instruments into the body with minimal trauma. It is commonly used in procedures requiring access to deep-seated anatomical structures, such as neurosurgical and pleural interventions.
FDA-Cleared Indications
- For percutaneous introduction of catheters and other compatible interventional devices.
- For providing temporary vascular or other anatomical access during diagnostic or therapeutic procedures.
- For use with compatible devices when the introducer sheath must be split and removed after device placement.
Clinical Applications
- Percutaneous access for catheter-based embolization procedures.
- Access for neurointerventional procedures involving compatible catheters and instruments.
- Access for vascular, visceral, pelvic, or other interventional procedures requiring a peel-away sheath.
- Temporary access during procedures in which a catheter or device is advanced through the introducer and the sheath is subsequently peeled away.
Reported off-label uses
- Use as a temporary access sheath for selected nonvascular or specialty procedures when the operator confirms that the device size, materials, and mechanical characteristics are appropriate.
- Use in pleural or other confined anatomical access procedures with compatible instruments; this should be based on operator judgment and is not established by the supplied FDA indication text.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, retrospective, and case series designs, published between 2020 and 2025. These studies explore the device's application in various clinical settings, including neurosurgery and pleuroscopy.
Reported Outcomes
Published studies report that the peel-away introducer facilitates minimally invasive access to deep-seated lesions, reduces procedural trauma, and is cost-effective. It has been shown to be effective in enhancing the safety and efficiency of neurosurgical and pleural procedures.
Safety Profile
Reported complications include potential obstruction of the introducer by thrombus during procedures, which can be managed with alternative techniques. Overall, the device is associated with a low incidence of adverse events when used appropriately.
Evidence Limitations
Current evidence is limited by small sample sizes and the need for further large-scale studies to validate findings. There is also a need for more comprehensive data on long-term outcomes and safety across diverse patient populations.
Practical Considerations
- The listed model numbers represent multiple sizes; the sheath inner diameter, usable length, and dilator compatibility should be confirmed against the current Abbott Medical labeling before use.
- Select a size that accommodates the planned catheter or instrument while maintaining controlled access and minimizing tissue trauma.
- The device is peel-away: stabilize the catheter or instrument, split the sheath according to the instructions for use, and remove it carefully to avoid catheter displacement or tissue injury.
- It is a single-use device and should not be resterilized or reused. Inspect packaging and components before use, and do not use a damaged or expired device.
- MRI safety should be determined from the current device-specific labeling. A peel-away introducer left in the patient, or used with another device, may require MRI-conditional assessment of the complete system.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the peel-away introducer?
The device is indicated for use in minimally invasive procedures requiring access to deep-seated anatomical structures, such as neurosurgery and pleuroscopy.
What outcomes have been reported in clinical studies?
Studies have reported that the device reduces procedural trauma and facilitates efficient access to complex anatomical areas, with positive outcomes in neurosurgical and pleural procedures.
What complications have been reported?
Safety data indicate potential complications such as thrombus obstruction during procedures, which can be managed with specific techniques. Overall, the device is associated with a low incidence of adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.