FlowCardia, Inc., a medical
device company focused on catheter-based devices for coronary and
peripheral chronic total occlusion (CTO) recanalization, announced Dr.
Naveen Sachdev from Providence St. Vincent's Hospital in Portland, Oregon,
successfully enrolled the first patient into the PATRIOT study.
FlowCardia's 10 hospital, 85 patient PATRIOT (Peripheral Approach To
Recanalization In Occluded Totals) U.S. pivotal study is designed to
determine the safety and efficacy of the CROSSER 14 and CROSSER 18
Catheters for CTO recanalization in the upper and lower legs.
The CROSSER(TM) System is a monorail catheter delivered over standard
.014" and .018" guidewires to the site of a CTO. The CROSSER utilizes high
frequency vibration to quickly cross CTOs allowing for subsequent plaque
debulking, balloon angioplasty and stent placement. For many patients with
chronic occlusions in the legs, this minimally invasive, endovascular
approach to CTO recanalization will eliminate the need for potentially
traumatic bypass surgery or amputation.
FlowCardia also announced FDA 501(k) submission for the CROSSER 14
coronary platform. The data used to support the coronary submission came
from FlowCardia's 19 hospital, 125 patient U.S. FACTOR (FlowCardia's
Approach to Chronic Total Occlusion Recanalization) pivotal study. The
FACTOR Study was designed to assess the safety and efficacy of the CROSSER
Catheter for chronically occluded coronary artery recanalization.
Wick Goodspeed, President and CEO of FlowCardia said, "With our 510(k)
submission filed with the FDA, we anticipate receiving coronary clearance
for the CROSSER 14 Catheter by the end of this year."
FlowCardia, Inc. is a privately held medical device company established
in 2002 to design and manufacture a safe and effective CTO recanalization
system. Additional information is available on the Company's new Web Site
at flowcardia.
FlowCardia, Inc.
flowcardia
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