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News

FlowCardia prepares pivotal study for CTO Recanalisation Catheters

FlowCardia : 05 September, 2007  (New Product)
FlowCardia has completed the enrollment into the PATRIOT (Peripheral Approach To Recanalisation In Occluded Totals) pivotal study to take place in the USA.

FlowCardia’s eight hospital, 85 patient PATRIOT study was designed to assess the safety and efficacy of the peripheral line of Crosser Catheters in lower limb chronic total occlusions (CTOs).

The Crosser is a rapid exchange Catheter delivered over standard 0.014inch and 0.018inch guidewires to the site of a CTO. Utilising high frequency vibration, the Crosser Catheter is designed to safely and quickly cross CTOs allowing for subsequent debulking, balloon angioplasty and Stent placement. The Crosser 14P, Crosser 14S and Crosser 18 Catheters were studied in the PATRIOT Trial.

Dr Jim Joye, the PATRIOT Study principal investigator commented, “We were very pleased with the success of the Crosser in the PATRIOT Study. The device worked well in the upper leg and also proved safe and effective crossing the more difficult, below the knee occlusions. This new endovascular line of catheters will help us cross lesions that previously could only be treated with a more invasive open surgery.'

“We are very pleased with the results from the PATRIOT Study”, said Wick Goodspeed, president and CEO of FlowCardia. “Having three Crosser Catheter models for use in the study allowed physicians to choose the appropriate Catheter based on vessel size and CTO location. The Crosser family delivered a simple, safe and effective solution for crossing CTOs in the legs.”
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