Unipearls R Embolic Microspheres
Suzhou Haowei Medical Technology
FDA Clearance Information
The unipearls r embolic microspheres were cleared through the FDA 510k pathway on November 14, 2023. Manufactured by Suzhou Haowei Medical Technology, this device is classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Embolization procedures to occlude blood vessels.
Clinical Applications
- Catheter-based occlusion of selected blood vessels.
- Reduction or interruption of blood flow to a targeted vascular territory.
- Embolization performed by trained clinicians for conditions requiring therapeutic vessel blockage.
Reported off-label uses
- Embolization of hypervascular tumors.
- Uterine fibroid embolization.
- Treatment of selected gastrointestinal bleeding.
- Embolization of selected arteriovenous malformations.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Microsphere size should be selected according to the target vessel diameter, vascular anatomy, desired level of embolization and risk of nontarget embolization.
- The microspheres must be compatible with the selected microcatheter, delivery system and embolization technique; preparation and suspension should follow the product instructions for use.
- Angiography is used to define the target vessels, monitor particle delivery and confirm the final embolization result.
- Contraindications, warnings and handling requirements should be reviewed in the current manufacturer labeling. The supplied record does not establish MRI safety or MRI conditional conditions.
- Potential complications are related to embolization and the treated anatomy, including nontarget embolization, ischemia, pain, bleeding, infection and vessel injury.
Frequently Asked Questions
What is unipearls r embolic microspheres used for?
Unipearls r embolic microspheres are used for embolization procedures to occlude blood vessels, often in the treatment of tumors or vascular malformations.
What specialties typically use this device?
Interventional radiologists typically use this device in hospital settings for minimally invasive vascular procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in embolization procedures to occlude blood vessels, particularly for conditions that benefit from reduced blood flow.