April 3, 2012

Merit Medical Receives FDA Clearance for 30–60-µm QuadraSphere

March 26, 2012—Merit Medical Systems, Inc. (South Jordan, UT) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for their 30–60-µm QuadraSphere microspheres. The microspheres measure 30-60 µm when packaged in their dry state and, when reconstituted for use, they expand to 120-240 µm.

The FDA has cleared QuadraSphere microspheres for the embolization of hypervascular tumors and arteriovenous malformations. They are not available for sale outside the United States.

According to Merit Medical, QuadraSphere microspheres are calibrated, spherical, hydrophilic microspheres made from two monomers (vinyl acetate and methyl acrylate) that combine to form a copolymer (sodium acrylate alcohol copolymer). This design allows for more complete and targeted occlusion of the blood vessels feeding a hypervascular tumor or arteriovenous malformation.

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April 3, 2012

Merit Medical Receives FDA Clearance for 30–60-µm QuadraSphere

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