Starclose Se R Vascular Surgical System
Abbott Vascular Devices
FDA Clearance Information
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
FDA-Cleared Indications
- The FDA record identifies approval for a manufacturing site to perform sterilization of the StarClose SE R Vascular Surgical System.
- The device is associated with closure of femoral artery access sites following catheterization procedures, according to the product description and device classification.
Clinical Applications
- Closure of a femoral artery puncture site after diagnostic catheterization.
- Closure of a femoral artery access site after an interventional cardiology procedure.
- Closure of a femoral artery access site after a peripheral vascular intervention.
Practical Considerations
- The system is intended for use at femoral arterial access sites; vessel anatomy and puncture location should be evaluated before deployment.
- Use requires appropriate imaging or procedural assessment to confirm access-site anatomy and suitability for a vascular closure device.
- Clinicians should follow the current FDA-approved labeling for access-site requirements, compatible sheath sizes, deployment technique, and contraindications.
- Potential complications include bleeding, hematoma, infection, arterial stenosis or occlusion, pseudoaneurysm, and failure of hemostasis.
- MRI safety depends on the implanted nitinol clip and the current product labeling; confirm the device's MR conditions before an MRI examination.
Linked Studies (2)
The use of the StarClose device for obtaining femoral artery hemostasis.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source →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.