Nitiloop Earns First FDA Clearance

Isareli company Nitiloop has received U.S. Food and Drug Administration (FDA) clearance for its first product, Novacross, which is intended to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature.

Novacross functions both as a supporting microcatheter and as a low profile microcatheter on its own. The product gains its supportive characteristic through the use of an operator-controlled Nitinol scaffold and an extendable segment, both located at its distal end.

In addition to the recent granting of FDA clearance, the company reported successful results from a first-in-human European multicenter study which looked at Novacross’s ability to cross CTOs in the coronary vasculature. The device was successfully used in 22 patients, half of whom had undergone a prior failed CTO attempt. According to Nitiloop, Novacross enabled crossing of the CTO in its entirety in 82 percent of cases. At 30 days after the procedure, there were no reports of any major adverse cardiac events.

The company is currently conducting a pivotal trial in order to be cleared for a CTO indication in the coronary vasculature.

Furthermore, the first patient has been successfully enrolled in the company’s first-in-human trial to evaluate the safety and efficacy of Novacross in the peripheral vasculature, with a focus on below-the-knee procedures.

“We are very excited at receiving FDA clearance, which represents an important first milestone for the company,” said Chanan Schneider, CEO of Nitiloop. “We are encouraged by the positive results from the European multicenter study on Novacross’s safety and efficacy in coronary CTOs, and look forward to replicating them in our pivotal study and first-in-human in the below-the-knee segment within the coming months.”

Nitiloop makes cardiovascular and peripheral supporting microcatheters for complex lesions and chronic total occlusions.