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modified hd guide catheter
Concentric Medical
Summary: The modified HD guide catheter by Concentric Medical is a Class 2 device cleared by the FDA for use in venous stenting procedures. Key evidence highlights its application in mapping catheter geometry and its effects on rotor detection in atrial fibrillation.
FDA Clearance Information
Pathway
510K
Number
K080583 ↗
Decision Date
July 18, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modified HD guide catheter was cleared by the FDA through the 510(k) pathway on July 18, 2008. It is manufactured by Concentric Medical and classified as a Class 2 device.
What It Is
The modified HD guide catheter is designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous locations, aiding in the treatment of vascular conditions.
Clinical Applications
This device is commonly used in procedures requiring venous stenting, particularly in cases where precise catheter placement is critical. It is utilized in interventional cardiology and vascular surgery settings.
Evidence Summary
The available literature includes 9 studies, with a mix of RCTs, prospective, and retrospective analyses. The studies span from 2015 to 2021, focusing on catheter mapping and its clinical implications.
Reported Outcomes
Published studies report that the modified HD guide catheter is effective in facilitating precise stent placement in venous procedures. It has been shown to improve mapping accuracy in atrial fibrillation cases, aiding in the detection of rotors.
Safety Profile
Reported complications include potential issues with catheter placement and the risk of vascular injury. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base is limited by the small number of studies directly addressing the device's safety and efficacy. Further research is needed to fully understand long-term outcomes and potential complications.
Frequently Asked Questions
What are the clinical indications for modified HD guide catheter?
The device is indicated for use in venous stenting procedures, particularly in cases requiring precise catheter placement.
What outcomes have been reported in clinical studies?
Studies have reported improved mapping accuracy in atrial fibrillation and effective stent delivery.
What complications have been reported?
Complications include potential catheter placement issues and vascular injury risks.
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.