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acufex t-fix delivery system
Acufex Microsurgical
Summary: The Acufex T-Fix Delivery System is a medical device used for uterine fibroid embolization procedures. It is primarily utilized by interventional radiologists to treat patients with symptomatic uterine fibroids.
FDA Clearance Information
Pathway
510K
Number
K942442 ↗
Decision Date
December 5, 1994
Product Code
MIA
Device Class
Class 2
Evidence
0 studies
The Acufex T-Fix Delivery System was cleared through the FDA 510(k) pathway on December 5, 1994. It is manufactured by Acufex Microsurgical and classified as a Class 2 medical device under product code MIA.
What It Is
The Acufex T-Fix Delivery System is a specialized device designed to facilitate the delivery of embolic agents during uterine fibroid embolization procedures. It consists of a catheter system that allows precise placement of embolic materials to occlude blood supply to uterine fibroids, thereby reducing their size and alleviating symptoms. The device is engineered to provide controlled delivery and is compatible with various embolic agents.
Clinical Applications
This device is commonly used in interventional radiology settings for the treatment of symptomatic uterine fibroids, which can cause heavy menstrual bleeding and pelvic pain. It is typically employed in outpatient or hospital settings where minimally invasive procedures are performed. The primary patient population includes women of reproductive age experiencing significant symptoms from fibroids.
Indications for Use
The FDA-cleared indication for the Acufex T-Fix Delivery System is for use in uterine fibroid embolization, a procedure aimed at reducing the size of fibroids by cutting off their blood supply. It is intended for patients who have symptomatic fibroids causing issues such as heavy bleeding or pain.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural requirements. It is important for clinicians to ensure compatibility with the chosen embolic agents and to be familiar with the catheter's handling characteristics for optimal performance during the procedure.
Frequently Asked Questions
What is the Acufex T-Fix Delivery System used for?
It is used for uterine fibroid embolization to treat symptomatic fibroids.
What specialties typically use this device?
Interventional radiologists primarily use this device in procedures involving uterine fibroids.
What are the FDA-cleared indications?
The device is indicated for uterine fibroid embolization, targeting fibroids causing symptoms like heavy bleeding or pain.
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.