Teleport Microcatheter
Orbusneich Medical Trading
FDA Clearance Information
The Teleport Microcatheter was cleared through the FDA 510(k) pathway on November 9, 2018. It is manufactured by Orbusneich Medical and is classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- To facilitate the placement and exchange of guidewires during percutaneous coronary intervention.
- For use in the coronary vasculature when additional guidewire support or access is needed.
- For use by trained physicians during catheter-based coronary procedures.
Clinical Applications
- Guidewire support during percutaneous coronary intervention.
- Guidewire exchange during coronary catheterization.
- Navigation through tortuous or otherwise challenging coronary anatomy.
- Support during treatment of difficult coronary lesions, including chronic total occlusions, when consistent with the device labeling and procedural plan.
Reported off-label uses
- Use in selected peripheral vascular interventions as a general-purpose support or exchange microcatheter.
- Delivery or exchange of devices in noncoronary vessels.
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 sizes and configurations should be matched to the target vessel, guide catheter, guidewire, and planned intervention.
- Use is performed under fluoroscopic imaging, generally through arterial access such as the radial or femoral artery, with local anesthesia and possible moderate sedation.
- The catheter is intended to work with compatible guidewires and interventional equipment; users should verify compatibility before the procedure.
- Potential complications include vessel injury, dissection, perforation, spasm, thrombosis, embolization, bleeding, infection, and contrast-related adverse events.
- MRI safety depends on the exact device configuration and manufacturer labeling. The device should not be considered MRI safe or MRI conditional without confirming the current instructions for use.
Related Literature
Frequently Asked Questions
What is the Teleport Microcatheter used for?
The Teleport Microcatheter is used to facilitate guidewire navigation and support during complex coronary interventions, particularly in chronic total occlusions.
What specialties typically use this device?
Interventional cardiologists primarily use the Teleport Microcatheter in hospital catheterization labs for coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring enhanced guidewire support, especially in chronic total occlusions during percutaneous coronary interventions.