Nitiloop's NovaCross Microcatheter Cleared by FDA

May 18, 2015—Nitiloop announced that it has received US Food and Drug Administration 510(k) clearance for its NovaCross device, which is intended to be used with a guidewire to access discrete regions of the peripheral or coronary vasculature.

According to the company, NovaCross functions both as a supporting microcatheter and as a low-profile microcatheter on its own. NovaCross features an operator-controlled nitinol scaffold and an extendable segment, both located at its distal end.

Nitiloop advised that the first patient has been 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.

The company also reported that results from the first-in-human European multicenter study evaluating NovaCross’s ability to cross chronic total occlusions (CTOs) in the coronary vasculature. The device was successfully used in 22 patients, half of whom had undergone a previous 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 events. The company is currently conducting a pivotal trial in order to be cleared for a CTO indication in the coronary vasculature.