📊 Evidence-Based Reference
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 ?
510(k)
Number ?
K241538 ↗
Decision Date ?
August 26, 2024
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used to provide vascular access and steerable guidance for transcatheter procedures involving the tricuspid valve.
- Used with the TriClip system for transcatheter edge-to-edge repair of tricuspid regurgitation, according to the system's labeling.
Clinical Applications
- Steerable delivery and positioning of the TriClip system during transcatheter tricuspid valve repair.
- Catheter-based treatment of appropriately selected tricuspid regurgitation patients when the TriClip system is indicated.
- Femoral venous catheter access and guidance to the right atrium and tricuspid valve during the procedure.
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.
Practical Considerations
- The catheter is intended to be used with compatible TriClip system components; compatibility should be confirmed in the current manufacturer instructions for use.
- The procedure generally requires femoral venous access, fluoroscopy, and transesophageal echocardiographic guidance, with conscious sedation or general anesthesia depending on the case.
- Patient selection depends on tricuspid valve anatomy, severity and cause of regurgitation, symptoms, comorbidities, and surgical risk.
- Potential catheterization risks include bleeding or hematoma at the access site, vascular injury, infection, arrhythmia, thromboembolism, cardiac injury, and complications related to anesthesia or imaging.
- MRI safety and conditions are device- and component-specific. The current labeling should be checked before MRI; do not assume the catheter or retained components are MR safe or MR conditional.
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.