Israeli medical device maker Nitiloop said today that it won 510(k) clearance from the FDA for a pair of its micro-catheters.
Netanya, Israel-based Nitiloop said the federal safety watchdog cleared its Nova Cross Extreme coronary micro-catheter and its Nova Cross BTK peripheral device.
“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,” CEO Chana Schneider said in prepared remarks.
“With the continuing rise in CAD 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,” added Dr. William Nicholsonof Pennsylvania’s York Hospital.
Nitiloop said it recently closed a 145-patient pivotal study of another micro-catheter, the NovaCross CTO, designed to cross chronic total occlusions in coronary arteries.
“The company submitted study results and is expecting FDA feedback within the next weeks,” Nitiloop said.