BioSphere gets FDA nod for QuadraSphere

Interventional device developer BioSphere Medical reported that the U.S. Food and Drug Administration has cleared the 510(k) application for the company's QuadraSphere microspheres.

QuadraSpheres are indicated to treat hypervascularized tumors and peripheral arteriovenous malformations, and are delivered by interventional radiologists who perform embolization procedures.

The product expands up to four times its dry-state diameter, and absorbs aqueous media up to 64 times its dry-state volume, the company said. In addition to the absorption process, the negatively charged polymer is capable of selective bonding with positively charged substances through ionic interaction. QuadraSphere affords atraumatic conformability to vessel architecture, leading to a more complete vessel occlusion, according to the Rockland, MA-based firm.

BioSphere said that U.S. shipments through its direct sales force are expected to begin immediately.

By AuntMinnie.com staff writers
November 9, 2006

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