The US Food and Drug Administration (FDA) has granted 510(k) approval to Merit Medical Systems' 30-60um QuadraSphere microspheres.
QuadraSphere microspheres measure 30-60um, when packaged in their dry state, but when reconstituted for use, they expand to 120-240um.
Merit chairman and chief executive officer Fred Lampropoulos said the product is an important addition to company’s embolic portfolio and will be featured at the society of interventional radiology (SIR) meeting this week in San Francisco, California, US.
Merit develops, manufactures and distributes proprietary disposable medical devices used in interventional and diagnostic procedures in endoscopy, cardiology and radiology.
Headquartered in US, Merit has facilities in Netherlands, France, Ireland, China, Denmark.