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Starclose Hex-Hub Dilator
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.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K062554 ↗
Decision Date ?
February 6, 2007
Product Code ?
DRE
Device Class ?
Class 2
Evidence ?
2 studies
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.
FDA-Cleared Indications
- Used with the StarClose vascular closure system to assist closure of common femoral artery access sites after catheter-based procedures.
- Intended for femoral artery puncture sites in patients who have undergone percutaneous vascular interventions.
- Used to facilitate hemostasis at the femoral arterial access site.
Clinical Applications
- Preparation of a common femoral artery access tract before deployment of a mechanical vascular closure device.
- Femoral access-site closure after cardiac catheterization.
- Femoral access-site closure after peripheral vascular intervention.
- Achieving hemostasis after removal of a femoral arterial catheter or sheath.
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.
Practical Considerations
- The dilator is used as part of a compatible StarClose closure-system workflow; it is not a stand-alone treatment for arterial bleeding.
- Use requires suitable common femoral artery anatomy and confirmation that the puncture is in an appropriate location, typically with fluoroscopic or ultrasound assessment when clinically indicated.
- It should not be used for venous access, nonfemoral arterial access, or punctures involving the superficial femoral artery, profunda femoris artery, or a high pelvic location unless specifically addressed by the applicable labeling.
- Patients with significant femoral artery calcification, small vessel diameter, infection at the access site, uncontrolled bleeding, or clinically important coagulopathy may have increased risk of complications.
- MRI safety depends on the implanted closure component and its current labeling; the dilator itself is removed, but patients should provide the implant card or procedure information before MRI.
Linked Studies (2)
PubMed • 2012
The use of the StarClose device for obtaining femoral artery hemostasis.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2006
Use of the profunda femoris to facilitate closure of an antegrade puncture with the StarClose device after proximal SFA angioplasty.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
Other View Source →Frequently Asked Questions
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.