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news.Medical device company FlowCardia has announced FDA 510(k) clearance and immediate US launch of the Crosser 14P, Crosser 14S and Crosser 18 CTO recanalization catheters.
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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 that utilizes high frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement.
Chris Barys, senior vice president of sales of FlowCardia, 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.”