Summary: The StarClose Hex-Hub Dilator by Abbott Vascular is a vascular closure device primarily used for femoral artery hemostasis. Key evidence suggests its effectiveness in cardiac catheterization and peripheral vascular disease interventions.
The StarClose Hex-Hub Dilator was cleared by the FDA through the 510(k) pathway on February 6, 2007. It is manufactured by Abbott Vascular and classified as a Class 2 device under product code DRE.
What It Is
The StarClose Hex-Hub Dilator is a vascular closure device designed to achieve hemostasis of the femoral artery following percutaneous interventions. It operates by mechanically closing the arterial puncture site, facilitating rapid and reliable closure.
Clinical Applications
This device is commonly used in clinical settings following cardiac catheterization and peripheral vascular interventions. It is particularly useful in achieving hemostasis in patients undergoing procedures involving the femoral artery.
Evidence Summary
The available literature includes two studies published between 2006 and 2012. These studies encompass a range of methodologies, including retrospective and prospective analyses, focusing on the device's application in femoral artery closure.
Reported Outcomes
Published studies report that the StarClose device is effective in achieving femoral artery hemostasis with minimal complications. Its use in cardiac catheterization and peripheral vascular disease interventions has shown promising results in terms of safety and efficacy.
Safety Profile
Reported complications include minimal adverse events associated with the use of the StarClose device. The studies indicate a low incidence of complications, supporting its safety profile in clinical applications.
Evidence Limitations
The evidence is limited by the small number of studies and the specific patient populations examined. Further research is needed to explore its efficacy and safety in a broader range of clinical scenarios and larger patient cohorts.
Linked Studies (2)
PubMed • 2012
The use of the StarClose device for obtaining femoral artery hemostasis.
What are the clinical indications for StarClose Hex-Hub Dilator?
The device is indicated for achieving femoral artery hemostasis following percutaneous interventions, particularly in cardiac catheterization and peripheral vascular procedures.
What outcomes have been reported in clinical studies?
Studies report effective femoral artery closure with minimal complications, demonstrating the device's efficacy in both cardiac and peripheral vascular interventions.
What complications have been reported?
Safety data from evidence indicate minimal adverse events, with a low incidence of complications associated with the device's use.
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.
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