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telescope guide extension catheter
Medtronic, Ireland
Summary: The telescope guide extension catheter by Medtronic is a device used to facilitate percutaneous coronary interventions. Key evidence highlights its utility in challenging anatomical scenarios, with studies focusing on its application in coronary and neuroendovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K252390 ↗
Decision Date
October 29, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The telescope guide extension catheter received FDA clearance via the 510(k) pathway on October 29, 2025. Manufactured by Medtronic, Ireland, it is classified as a Class 2 device.
What It Is
The telescope guide extension catheter is designed to provide additional support and stability during percutaneous coronary interventions. It is intended to assist in the precise placement of stents in complex coronary anatomies.
Clinical Applications
This device is commonly used in scenarios involving challenging coronary anatomies, such as ostial lesions or tortuous vessels, where additional support is required for stent delivery. It is also utilized in neuroendovascular interventions to navigate severe vessel angulations.
Evidence Summary
The literature includes 7 studies, ranging from case series to retrospective analyses, published between 2018 and 2025. These studies explore the device's application in both coronary and neuroendovascular procedures.
Reported Outcomes
Published studies report that the telescope guide extension catheter enhances the precision of stent placement in complex coronary interventions. It is noted for its ability to provide additional support in challenging anatomical scenarios, improving procedural success rates.
Safety Profile
Reported complications include stent damage during insertion and challenges in navigating tortuous vessels. These issues highlight the need for careful handling and consideration of anatomical complexities during use.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and to explore its efficacy in a broader range of clinical scenarios.
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 challenging anatomical scenarios such as ostial lesions and tortuous vessels.
What outcomes have been reported in clinical studies?
Studies report improved precision in stent placement and enhanced procedural success in complex interventions.
What complications have been reported?
Safety data indicate potential complications such as stent damage and difficulties in navigating tortuous vessels.
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.