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starclose se r vascular surgical system
Abbott Vascular Devices
Summary: The StarClose SE R Vascular Surgical System is a device used for vascular closure following catheterization procedures. It is primarily used by interventional cardiologists and radiologists to achieve hemostasis quickly and effectively.
FDA Clearance Information
Pathway
PMA
Number
P050007 ↗
Decision Date
February 10, 2025
Product Code
MGB
Device Class
Class 3
Evidence
2 studies
The StarClose SE R received FDA clearance under PMA P050007 on February 10, 2025. Manufactured by Abbott Vascular Devices, it is classified as a Class 3 medical device.
What It Is
The StarClose SE R Vascular Surgical System is a vascular closure device designed to close femoral artery access sites following catheterization procedures. It works by deploying a small nitinol clip to mechanically close the puncture site, promoting rapid hemostasis. This device is particularly useful in reducing time to ambulation and discharge for patients undergoing diagnostic or interventional procedures.
Clinical Applications
Commonly used in interventional cardiology and radiology, the StarClose SE R is employed in settings where rapid vascular closure is beneficial, such as after coronary angiography or peripheral interventions. It is suitable for use in both inpatient and outpatient settings, and is particularly advantageous for patients who require quick recovery and discharge.
Indications for Use
The FDA indications for the StarClose SE R include its use for closing femoral artery access sites post-catheterization. This device is intended for patients who have undergone procedures requiring arterial access and need rapid hemostasis.
Practical Considerations
The StarClose SE R is compatible with standard femoral artery access sizes and is designed for ease of use with a straightforward deployment technique. Clinicians should be familiar with the femoral anatomy and have experience with vascular closure devices to ensure optimal outcomes.
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 is StarClose SE R used for?
The StarClose SE R is used for closing femoral artery access sites following catheterization procedures to achieve hemostasis.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the StarClose SE R for vascular closure after catheter-based procedures.
What are the FDA-cleared indications?
The device is indicated for use in closing femoral artery access sites post-catheterization to achieve rapid hemostasis.
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.