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telescope guide extension catheter
Medtronic
Summary: The telescope guide extension catheter by Medtronic is used primarily in percutaneous coronary interventions to facilitate stent placement. Key evidence highlights its utility in complex coronary anatomies.
FDA Clearance Information
Pathway
510K
Number
K183353 ↗
Decision Date
March 22, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The telescope guide extension catheter was cleared by the FDA via the 510(k) pathway on March 22, 2019. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The telescope guide extension catheter is a device designed to provide additional support and reach during percutaneous coronary interventions. It assists in the precise placement of stents, particularly in challenging coronary anatomies.
Clinical Applications
Commonly used in scenarios involving complex coronary lesions, such as those near the ostium of the left anterior descending artery, where precise stent placement is critical. It is also utilized in cases with severe vessel tortuosity.
Evidence Summary
The literature includes 7 studies, comprising case series and other observational designs, published between 2018 and 2025. These studies explore the device's application in coronary and neuroendovascular interventions.
Reported Outcomes
Published studies report that the telescope guide extension catheter facilitates successful stent placement in complex coronary anatomies. It is noted for its ability to provide additional support in tortuous vessels, improving procedural outcomes.
Safety Profile
Reported complications include stent damage and resistance during insertion, as noted in specific case reports. These issues highlight the need for careful handling and technique during use.
Evidence Limitations
The evidence is primarily observational, with limited randomized controlled trials. Further research is needed to quantify long-term outcomes and compare efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for telescope guide extension catheter?
The device is indicated for use in percutaneous coronary interventions, particularly in complex coronary anatomies requiring precise stent placement.
What outcomes have been reported in clinical studies?
Studies report improved procedural success in challenging coronary interventions, with the device providing necessary support for stent delivery.
What complications have been reported?
Safety data indicate potential complications such as stent damage and resistance during insertion, necessitating careful procedural technique.
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.