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teleport microcatheter
Orbusneich Medical Trading
Summary: The Teleport Microcatheter is a device used in interventional cardiology for chronic total occlusion (CTO) procedures. It is primarily used by cardiologists to improve guidewire support during percutaneous coronary interventions.
FDA Clearance Information
Pathway
510K
Number
K182360 ↗
Decision Date
November 9, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
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
The Teleport Microcatheter is a specialized catheter designed to facilitate the delivery of guidewires and other interventional devices during complex coronary procedures. It is engineered to enhance deliverability and resistance to deformation, making it particularly useful in navigating challenging vascular anatomy. The device is part of a new generation of microcatheters that offer improved performance characteristics for interventional cardiologists.
Clinical Applications
The Teleport Microcatheter is commonly used in the treatment of chronic total occlusions (CTOs) during percutaneous coronary interventions (PCI). It is particularly valuable in interventional cardiology settings where precise guidewire control is essential. The device is used in hospital catheterization labs by cardiologists who specialize in complex coronary interventions, often involving patients with advanced coronary artery disease.
Indications for Use
The FDA indications for the Teleport Microcatheter include its use in procedures requiring enhanced guidewire support, particularly in the context of chronic total occlusions. It is intended for patients undergoing PCI where traditional guidewire navigation is challenging.
Practical Considerations
The Teleport Microcatheter is available in various sizes to accommodate different vessel anatomies. It is compatible with standard guidewires and is designed for use with existing interventional equipment. Clinicians should be familiar with its handling characteristics to optimize performance during procedures.
Related Literature
The linked study, published in 2019, reviews advancements in microcatheter technology, including the Teleport Microcatheter, for treating chronic total occlusions. It highlights the improved deliverability and deformation resistance of new microcatheters compared to older models. The study suggests that while these devices offer enhanced options for guidewire support, further clinical experience and comparative studies are needed to fully understand their role in contemporary CTO PCI.
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.
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.