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News

FlowCardia launches new CTO Recanalisation Catheter range in the USA

FlowCardia : 12 December, 2007  (New Product)
FlowCardia has receiveded FDA 510(k) clearance of the Crosser 14P, Crosser 14S and Crosser 18 CTO Recanalisation Catheters and the company has immediately launched in the catheter range in theUSA.
FlowCardia has receiveded FDA 510(k) clearance of the Crosser 14P, Crosser 14S and Crosser 18 CTO Recanalisation Catheters and the company has immediately launched in the Catheter range in theUSA.

The three peripheral Crosser Catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross chronic total occlusions (CTOs) to help restore blood flow to the lower legs. The Crosser is a rapid exchange Catheter delivered over standard 0.014inch and 0.018inch guidewires that utilises high frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and Stent placement. The peripheral Crosser Catheters were studied in the FlowCardia Patriot Trial.

The Patriot Study principle investigator, Dr Jim Joye, commented, 'After completing the clinical trial, we are looking forward to using the Crosser in our daily practice. The device worked well in the upper leg and also proved an excellent primary therapy for 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.'

Chris Barys Sr, Flowcardia’s vice president of sales said: 'We are aggressively assembling our sales organization and we look forward to offering a complete, peripheral portfolio of catheters to our interventional customers. Having three Crosser Catheter models available for use in the peripheral vasculature will allow physicians to choose the appropriate Catheter based on vessel size and CTO location. This approval is significant and a true win for patients all over the world.'
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