BioSphere to market EmboCath Plus infusion microcatheter

By Elaine Rigoli

Tampa, Fla., Aug. 14 - The Food and Drug Administration has cleared for marketing in the United States BioSphere Medical, Inc.'s EmboCath Plus infusion microcatheter, which is expected to begin shipping in the United States in September.

EmboCath Plus is designed to deliver embolic, diagnostic and therapeutic agents into the peripheral vascular system for interventional procedures such as uterine fibroid embolization and the embolization of hypervascularized tumors, officials said.

EmboCath Plus was designed for use with BioSphere Medical's existing and planned new products, including the Sequitor Steerable Guidewire, which received FDA approval in June and which will begin shipping this month, as well as the currently marketed Embosphere Microspheres, EmboGold Microspheres and QuadraSphere Microspheres product candidate, for which the company has submitted a 510(k) premarket notification.

"EmboCath Plus is the second FDA approval received by BioSphere Medical this year. I believe that this approval demonstrates our ability to effectively advance new product candidates rapidly through development and engineering, and regulatory approval. EmboCath Plus and our recently approved Sequitor Steerable Guidewire build upon the advantages of our first-generation embolic delivery system by providing a new fully integrated system for optimal embolic performance," executive vice president and chief operating officer Gary Saxton said in a news release.

BioSphere is a medical-device company based in Rockland, Mass.

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