FDA 510(k) clearance for Nitiloop’s Nova Cross Extreme and Nova Cross BTK microcatheters

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Nitiloop has received FDA clearance for its new Nova Cross Extreme and Nova Cross BTK. According to the company, these dedicated microcatheters are joining the Nova Cross product family “combining innovative low profile microcatheter technology with uniquely designed nitinol scaffold providing enhanced guidewire and microcatheter support for safer and more effective lesion crossing”.

The Nova Cross Extreme and Nova Cross BTK are intended to be used in conjunction with conventional guidewires to access discrete regions of the coronary and peripheral vasculature.

Recently, Nitiloop successfully completed a pivotal study evaluating the safety and effectiveness of the NovaCross CTO microcatheter when used to facilitate crossing of chronic total occlusion (CTO) lesions in coronary arteries. The study was conducted on 145 patients diagnosed with a CTO in a coronary vessel that required revascularisation after a previously failed attempt. The company submitted study results and is expecting FDA feedback within the next weeks.

William Nicholson, an expert in interventional cardiology at York Hospital, York, USA, said: “With the continuing rise in coronary artery disease prevalence and increasing complexity of lesions requiring recanalisation, the Nova Cross Extreme is a significant new addition to our tool box for tackling these lesions.”

Chana Schneider, CEO of Nitiloop, commented: “We are very excited at receiving FDA clearance for the Nova Cross Extreme and Nova Cross BTK, which further establishes our Nova Cross product family. We are encouraged by the positive medical community response to our new products bringing solution to one of the last unmet clinical need in the cathlab.”

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