Uterine Fibroid Embolization
Clinical Overview
| Device | Manufacturer | Pathway | Cleared | Evidence |
|---|---|---|---|---|
| embosphere microspheres and embogold microspheres for use in uterine fibroid embolization Evidence | Biosphere Medical | 510K | 2002 | 16 |
| acufex suretac ixc systems | Acufex Microsurgical | 510K | 1994 | β |
| acufex fixation post | Acufex Microsurgical | 510K | 1992 | β |
| acufex arthroscopic shaver | Acufex Microsurgical | 510K | 1985 | β |
| acufex arthroscope Evidence | Acufex Microsurgical | 510K | 1994 | β |
| acufex comparative surgical keratometer | Acufex Microsurgical | 510K | 1985 | β |
| acufex suretac r pac | Acufex Microsurgical | 510K | 1993 | β |
| acufex magnetic retriever | Acufex Microsurgical | 510K | 1982 | β |
| acufex suture retriever sterile disposable | Acufex Microsurgical | 510K | 1988 | β |
| acufex endobutton tape Evidence | Acufex Microsurgical | 510K | 1996 | β |
| acufex probes | Acufex Microsurgical | 510K | 1980 | β |
| acufex tag delivery system | Acufex Microsurgical | 510K | 1995 | β |
| acufex r endo-femoral aimer | Acufex Microsurgical | 510K | 1994 | β |
| acufex endobutton system | Acufex Microsurgical | 510K | 1994 | β |
| acufex arthroscopic shoulder guide system | Acufex Microsurgical | 510K | 1994 | β |
| acufex endofix button | Acufex Microsurgical | 510K | 1992 | β |
| acufex intra articular measuring device | Acufex Microsurgical | 510K | 1992 | β |
| acufex uni-cut 4 omm carpal tunnel cannula | Acufex Microsurgical | 510K | 1994 | β |
| acufex biofix absorbable fixation rod-modification Evidence | Acufex Microsurgical | 510K | 1993 | β |
| acufex r arthroplasty instruments | Acufex Microsurgical | 510K | 1994 | β |
| acufex mosaicplasty comprehensive system | Smith & Nephew Endoscopy | 510K | 1996 | β |
| acufex meniscal rasps | Acufex Microsurgical | 510K | 1994 | β |
| acufex video system | Acufex Microsurgical | 510K | 1994 | β |
| acufex tag anchor Evidence | Acufex Microsurgical | 510K | 1995 | β |
| acufex rotator cuff fixation button | Acufex Microsurgical | 510K | 1995 | β |
| acufex t-bar | Acufex Microsurgical | 510K | 1993 | β |
| acufex director application anatomic guide system | Smith & Nephew Inc., Endoscopy Div. | 510K | 2011 | β |
| acufex patellar bone block sizer | Acufex Microsurgical | 510K | 1995 | β |
| acufex suture retriever | Acufex Microsurgical | 510K | 1993 | β |
| acufex interference screw and screwdriver | Acufex Microsurgical | 510K | 1988 | β |
| acufex endofix absorbable interference screw | Acufex Microsurgical | 510K | 1996 | β |
| acufex acl sheath for interference screws | Acufex Microsurgical | 510K | 1994 | β |
| acufex sub-acromial space measuring device | Acufex Microsurgical | 510K | 1994 | β |
| acufex spiked washer system acufex suture washer system acufex cancellous screw and spiked washer system | Smith & Nephew | 510K | 2000 | β |
| acufex smooth and threaded pins | Acufex Microsurgical | 510K | 1994 | β |
| acufex tag bioabsorbable anchors | Acufex Microsurgical | 510K | 1996 | β |
| acufex endobutton pack | Acufex Microsurgical | 510K | 1995 | β |
| acufex screw cannula | Smith & Nephew Endoscopy | 510K | 1997 | β |
| surgical kit-acufex mosaicplasty system Evidence | Smith & Nephew Endoscopy | 510K | 1996 | β |
| acufex fixation button Evidence | Acufex Microsurgical | 510K | 1989 | β |
| acufex sterile drills | Acufex Microsurgical | 510K | 1994 | β |
| sime trufeel Evidence | Sime Health | 510K | 1991 | β |
| acufex interference screw sterile | Acufex Microsurgical | 510K | 1990 | β |
| acufex universal leg holder | Acufex Microsurgical | 510K | 1983 | β |
| acufex forceps | Acufex Microsurgical | 510K | 1980 | β |
| acufex arthroscopic discectomy systems | Acufex Microsurgical | 510K | 1995 | β |
| acufex drez communicating drill guide | Acufex Microsurgical | 510K | 1984 | β |
| acufex suretac Evidence | Acufex Microsurgical | 510K | 1994 | β |
| acufex tibial anchor screw spiked washer | Smith & Nephew Endoscopy | 510K | 1996 | β |
| acufex arthroscopic carpal tunnel release kit | Acufex Microsurgical | 510K | 1992 | β |
Evidence Landscape
Device Landscape
Clinical Workflow Considerations
Frequently Asked Questions
What are uterine fibroid embolization used for?
Uterine fibroid embolization is used to treat symptomatic uterine fibroids, addressing issues like heavy menstrual bleeding, pelvic pain, and pressure without the need for invasive surgery.
What clinical evidence is available for uterine fibroid embolization?
The evidence includes RCTs, registries, and case series, focusing on symptom relief and safety. Evidence quality is strong for immediate outcomes but less so for long-term comparisons with surgical interventions.
How do I choose between different uterine fibroid embolization?
Clinicians consider patient-specific factors such as fibroid size and location, anatomical considerations, and institutional resources when selecting embolization devices.
What complications are associated with uterine fibroid embolization?
Common complications include post-embolization syndrome, while serious complications can involve infection or non-target embolization. Overall, the safety profile is favorable.
What training is required for uterine fibroid embolization?
Training typically involves specialized interventional radiology fellowship programs, focusing on angiographic techniques and embolic material handling, with competency assessed through supervised procedures.