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triclip steerable guide catheter
Abbott Medical
Summary: The TriClip steerable guide catheter by Abbott Medical is used for transcatheter edge-to-edge repair of tricuspid regurgitation. Key evidence suggests it offers a minimally invasive alternative to surgery with promising outcomes.
FDA Clearance Information
Pathway
510K
Number
K241538 ↗
Decision Date
August 26, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The TriClip steerable guide catheter received FDA clearance via the 510(k) pathway on August 26, 2024. It is manufactured by Abbott Medical and classified as a Class 2 device.
What It Is
The TriClip steerable guide catheter is a medical device designed for transcatheter edge-to-edge repair of tricuspid regurgitation. It allows for precise navigation and positioning of the TriClip system, facilitating minimally invasive cardiac procedures.
Clinical Applications
This device is commonly used in patients with symptomatic severe tricuspid regurgitation who are at high risk for surgical repair. It provides a less invasive option for managing tricuspid valve dysfunction.
Evidence Summary
The available literature includes five studies, with publication years ranging from 2019 to 2025. These studies encompass various designs, including RCTs and case series, evaluating the safety and efficacy of the TriClip system.
Reported Outcomes
Published studies report that the TriClip steerable guide catheter is effective in reducing tricuspid regurgitation severity. The device has been associated with improved clinical outcomes and reduced procedural risks compared to traditional surgical approaches.
Safety Profile
Reported complications include procedural risks inherent to transcatheter interventions, such as vascular access complications and device malposition. However, the overall safety profile is favorable compared to surgical alternatives.
Evidence Limitations
Current evidence is limited by the relatively small sample sizes and short follow-up durations in available studies. Further research is needed to assess long-term outcomes and to expand the evidence base for diverse patient populations.
Frequently Asked Questions
What are the clinical indications for TriClip steerable guide catheter?
The device is indicated for use in patients with symptomatic severe tricuspid regurgitation who are at high surgical risk.
What outcomes have been reported in clinical studies?
Clinical studies have reported reductions in tricuspid regurgitation severity and improved patient outcomes with the use of the TriClip system.
What complications have been reported?
Safety data from studies indicate potential complications such as vascular access issues and device malposition, though these are less frequent compared to surgical 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.