Catheter Aids facilitate introduction and navigation.February 27, 2006 -
VP Wire and VP Sheath products are designed to facilitate introduction and navigation of balloon catheters and other interventional devices in PTA and PTCA procedures. Supportive 0.014 in. VP Wire is available in 165 and 300 cm lengths in Soft and Standard platforms. VP Sheath thin-walled 6 French catheter can be introduced through any 8F (0.086 in. ID) guide catheter or sheath, creating extended, supportive pathway for interventional devices.
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Original Press release
FlowCardia, Inc.
745 North Pastoria Ave.
Sunnnyvale, CA, 94085
USA
FlowCardia, Inc. Introduces First Products to Market and Delivers Clinical Update on the FACTOR U.S. Pivotal Trial
SUNNYVALE, Calif., Jan. 5 / -- FlowCardia, Inc. today announced U.S. 510K clearance and immediate market release of the VP Wire and VP Sheath product families. The company also delivered an encouraging progress report on their U.S. pivotal trial.
The new VP Wire and VP Sheath are designed to facilitate the introduction and navigation of balloon catheters and other interventional devices in PTA and PTCA procedures. The highly supportive 0.014" VP Wire will be available in 165cm and 300cm lengths in a Soft and Standard platform. The VP Sheath is a thin-walled 6 French catheter that can be introduced through any 8F (0.086" ID) guide catheter or sheath creating an extended, supportive pathway for interventional devices.
FlowCardia also announced more than 80 of the required 125 patients have been enrolled in the Pivotal Phase of the FACTOR Trial. The FACTOR Trial is FlowCardia's U.S. Clinical Trial for the CROSSER(TM) CTO Recanalization System. The CROSSER(TM) System which utilizes high frequency mechanical vibration is designed to safely and quickly cross CTO's allowing subsequent balloon angioplasty and stent placement. This minimally invasive, endovascular approach to CTO recanalization may eliminate the need for potentially traumatic cardiac surgery for a substantial subset of patients. The Company expects to complete Pivotal Phase enrollment in the 2nd quarter of this year.
"We are excited to be on the market with our new VP Wire and VP Sheath as we think these devices will give the interventionalist more options for treating difficult lesions. We look forward to completing enrollment in our FACTOR Trial and FDA clearance of the CROSSER(TM) System before the end of 2006," said Wick Goodspeed, President and CEO of FlowCardia.
FlowCardia, Inc. is a privately held medical device company established in 2002 to design and manufacture a safe and effective CTO recanalization system. CTO's remain one of the last major unresolved clinical challenges in peripheral and coronary intervention. Additional information is available on the Company's Web Site at www.flowcardia.com.
CONTACT: Mark Page 408-617-0352
Director of Marketing
FlowCardia, Inc.
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