US FDA 510(k) clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for support of guidewire access to discrete regions of the coronary and peripheral vasculature

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Nitiloop has received FDA clearance for its new Nova Cross Extreme and Nova Cross BTK. These dedicated microcatheters are joining the Nova Cross product family, which are designed to combined low-profile microcatheter technology with Nitinol scaffold to provide 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 Ltd. 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 revascularization after a previously failed attempt. The company submitted study results and is expecting FDA feedback within the next weeks.

William Nicholson (York hospital, PA,USA) comments: “With the continuing rise in coronary artery disease prevalence and increasing complexity of lesions requiring recanalization, the Nova Cross Extreme is a significant new addition to our tool box for tackling these lesions.”

“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 un-met clinical need in the Cath-lab,” Chana Schneider, chief executive officer of Nit loop Ltd comments.


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