p17 XR Microcatheter
Wallaby Medical
FDA Clearance Information
FDA-Cleared Indications
- Percutaneous introduction into the neurovasculature for diagnostic or therapeutic procedures.
- Delivery of contrast media or other compatible agents through the catheter during image-guided vascular procedures.
- Use by trained clinicians when the device is selected and used according to its FDA-cleared labeling and instructions for use.
Clinical Applications
- Selective catheterization of intracranial or other neurovascular vessels for angiography.
- Delivery of compatible embolic materials during image-guided treatment of selected neurovascular conditions.
- Support of minimally invasive neurointerventional procedures requiring distal vascular access.
Reported off-label uses
- Use in selected extracranial or non-neurovascular embolization procedures when clinicians determine that the catheter's specifications are appropriate.
- Delivery of embolic agents in some peripheral vascular procedures, subject to institutional review and the treating physician's judgment.
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.
Practical Considerations
- The available catheter lengths, distal tip configuration, inner diameter, and compatible guidewire sizes should be verified in the current product specifications and instructions for use.
- It is generally used through a compatible guide catheter or sheath under fluoroscopic or other appropriate imaging guidance.
- The catheter must be flushed and handled according to the manufacturer’s instructions; excessive force, sharp bends, or injection pressure above the labeled limit can cause device damage or vessel injury.
- MRI safety and conditions should be confirmed from the current labeling. Do not assume that a catheter left in the body is safe for MRI simply because it is used during an MRI-compatible procedure.
- Potential contraindications and risks include unsuitable vessel anatomy, vasospasm, dissection, perforation, thromboembolism, bleeding, infection, allergic reaction to contrast, and complications related to the access site.
Procedures that use this device
Frequently Asked Questions
What is the p17 XR Microcatheter used for?
It is used to access blood vessels, particularly in the neurovasculature, and to deliver contrast or compatible therapeutic materials during image-guided procedures. The exact cleared uses depend on the current FDA labeling and instructions for use.
Is the p17 XR Microcatheter MRI safe?
MRI safety cannot be determined from the device name alone. Check the current Wallaby Medical labeling for the exact MR Safe, MR Conditional, or MR Unsafe designation and any required scanning conditions.
What sizes does the p17 XR Microcatheter come in?
Catheter length, inner diameter, distal tip design, and guidewire compatibility can vary by configuration. Clinicians should verify the current product catalog and instructions for use before selecting a specific size.
How long does the p17 XR Microcatheter last?
It is generally a single-use device intended for one procedure, not a permanent implant. It is removed at the end of the procedure unless the labeling and clinical plan specifically state otherwise.
How much does the p17 XR Microcatheter cost?
The device price is not the same as the total procedure cost. Hospital charges, physician fees, imaging, anesthesia or sedation, embolic materials, facility location, and insurance coverage all affect the final amount.