Nitiloop announces 510(k) clearance for NovaCross microcatheter for support of guidewire access


Nitiloop has received 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 competent supporting microcatheter and as a premium low profile microcatheter on its own. NovaCross gains its supportive characteristic through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both located at its distal end.

In addition to the recent FDA clearance, the company reported successful results from a first in human European multicentre study which looked at NovaCross’ ability to cross chronic total occlusions (CTO) in the coronary vasculature. The device was successfully used in 22 patients, half of whom had undergone a prior failed CTO attempt. NovaCross enabled crossing of the CTO in its entirety in 82% of cases. At 30 days after the procedure, there were no reports of any major adverse cardiac event.

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.

Chanan Schneider, chief executive officer of Nitiloop, commented, “We are very excited at receiving FDA clearance, which represents an important first milestone for the company. We are encouraged by the positive results from the European multicentre 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.”