Teleport XT Microcatheter
OrbusNeich Medical (ShenZhen) Co., Ltd.
Product: Teleport XT Microcatheter — all models and sizes
FDA Clearance Information
The Teleport XT Microcatheter, manufactured by Orbusneich Medical (Shenzhen), was cleared via the FDA 510(k) pathway on January 7, 2024. It is classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Use as a percutaneous catheter during vascular procedures requiring navigation through the vasculature.
- Use to support delivery and placement of compatible endovascular devices, including venous stents, according to the device labeling.
- Use in adult patients when catheter-based vascular treatment is clinically indicated.
Clinical Applications
- Catheter-based delivery of compatible venous stents in iliac and central venous interventions.
- Image-guided treatment of venous obstruction when an appropriately sized endovascular device is indicated.
- Navigation through challenging vascular anatomy to position a compatible interventional device.
- Use during venous stenting procedures performed by trained interventional specialists.
Practical Considerations
- The catheter is available in multiple configurations and sizes; the selected size must match the target anatomy, guidewire, access system and intended endovascular device.
- Use requires fluoroscopic or other appropriate imaging guidance and trained catheter-navigation technique.
- Compatibility with the guidewire, introducer sheath and stent delivery system should be confirmed before the procedure.
- MRI safety and conditional-use details depend on the specific catheter configuration and manufacturer labeling; consult the current instructions for use rather than assuming it is MRI safe.
- Contraindications, warnings and handling requirements should be reviewed in the current FDA-cleared labeling. Potential concerns include vascular injury, bleeding, thrombosis, infection and device damage or entrapment.
Procedures that use this device
Frequently Asked Questions
What is the Teleport XT Microcatheter used for?
It is used for delivering venous stents in vascular procedures, particularly for treating venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital and catheterization lab settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stenting, particularly in patients with conditions like chronic venous disease.