đź“‹ FDA Reference
mitraclip g5 steerable guide catheter sgc0801 triclip g5 steerable guide catheter tsgc0801
Abbott Medical
Summary: The MitraClip G5 and TriClip G5 are steerable guide catheters used in minimally invasive procedures to treat mitral and tricuspid valve issues. They are primarily used by interventional cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K243224 ↗
Decision Date
December 31, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The MitraClip G5 and TriClip G5, manufactured by Abbott Medical, received FDA clearance through the 510(k) pathway on December 31, 2024. These devices are classified as Class 2 under product code DQY.
What It Is
The MitraClip G5 and TriClip G5 are advanced steerable guide catheters designed to facilitate the delivery of clip-based devices for mitral and tricuspid valve repair. These devices enable precise navigation and positioning within the heart's venous system, aiding in the treatment of valve regurgitation. Their steerability and compatibility with other valve repair systems make them crucial tools in percutaneous valve interventions.
Clinical Applications
These catheters are commonly used in interventional cardiology, particularly during transcatheter mitral and tricuspid valve repair procedures. They are employed in hospital catheterization labs, where cardiologists perform minimally invasive surgeries on patients with valve regurgitation. The devices are suitable for adult patients with symptomatic mitral or tricuspid valve insufficiency who are at high surgical risk.
Indications for Use
The FDA indications suggest these catheters are intended for use in procedures to repair mitral and tricuspid valve regurgitation. They are suitable for patients who are not ideal candidates for open-heart surgery due to high risk factors.
Practical Considerations
These catheters are designed to be compatible with various clip delivery systems, ensuring flexibility in procedural approach. Clinicians should be familiar with the specific sizing and maneuverability of these devices to optimize procedural outcomes. Proper training in catheter navigation and valve repair techniques is essential.
Frequently Asked Questions
What is MitraClip G5 & TriClip G5 used for?
These devices are used for minimally invasive repair of mitral and tricuspid valve regurgitation.
What specialties typically use this device?
Interventional cardiologists primarily use these devices in hospital catheterization labs.
What are the FDA-cleared indications?
The devices are indicated for use in patients with mitral or tricuspid valve regurgitation who are at high risk for surgical valve repair.
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.