SUNNYVALE, Calif., Jan. 28 /PRNewswire/ -- FlowCardia, Inc., a developer of catheter-based systems to treat Chronic Total Occlusions (CTOs) of coronary and peripheral arteries, today announced that the Company's application for CE marking of the CROSSER(TM) catheter has been approved for use in coronary arteries following failure to cross CTOs with conventional guidewire techniques. CE Mark approval allows the Company to market the CROSSER(TM) System in all member countries of the European Union. Additionally, many other countries outside of the European Union recognize the CE Mark for regulatory approval to market medical devices. FlowCardia's CROSSER(TM) System utilizes high frequency mechanical vibration to safely and quickly cross CTOs allowing subsequent balloon angioplasty and/or stent placement and obviating the need for potentially traumatic cardiac surgery.
Also today, FlowCardia announced that it received approval from the United States Food and Drug Administration (FDA) in December 2004 to start the Pivotal Phase of the U.S. Clinical Trial for its CROSSER(TM) System following completion of a U.S. Feasibility Study in September 2004. The first patients in the Pivotal Study have already been enrolled and it is expected that the Trial will be completed and a request for 510(k) clearance from the FDA will be submitted in the 2nd half of 2005.
"We are very encouraged by the clinical progress FlowCardia made in 2004 and look forward to completing patient enrollment in the U.S. trial in 2005 as the company moves toward FDA approval of the CROSSER(TM) System," said Wick Goodspeed, President and CEO of FlowCardia.
FlowCardia, Inc. is a privately held medical device company established in 2002 to develop an effective percutaneous treatment approach for CTOs, one of the last major unresolved clinical challenges in interventional cardiology. Additional information is available on the Company's Web Site at http://www.flowcardia.com/.
COMPANY CONTACT: Wick Goodspeed 408-617-0352 ext. 206
FlowCardia, Inc.CONTACT: Wick Goodspeed, President and CEO of FlowCardia, Inc.,+1-408-617-0352 ext. 206
Web site: http://www.flowcardia.com/
