FDA OKs BioSphere Medical’s Sequitor Steerable Guidewire

BioSphere Medical Inc., a Rockland, MA-based medical device company, has been cleared by the US Food and Drug Administration to market the BioSphere Medical Sequitor Steerable Guidewire in the United States. The company is expected to begin shipping Sequitor in the United States in July 2006.
    BioSphere’s internally developed Sequitor guidewire facilitates the placement of catheters within surrounding blood vessels for various interventional procedures, including both uterine fibroid embolization and embolization of hypervascularized tumors, such as liver tumors.
    Officials say BioSphere also expects to complete the CE marking of Sequitor and to launch it in Europe in July 2006. CE marking denotes conformity with European Medical Device Directive and allows for marketing in European Union countries.
    Richard Faleschini, BioSphere Medical’s president and CEO, said, “The introduction of Sequitor is a next step toward our goal to optimize BioSphere delivery systems products for peripheral embolization procedures. With Sequitor’s trackability, torque response, distal steerability, visibility under fluoroscopy, and innovative hydrophilic coating, we believe we have developed a best-in-class guidewire that will clearly establish BioSphere’s technical leadership in delivery system technology.”
    Publicly traded BioSphere Medical was founded in 1993 and has about 70 employees.