Nitiloop Announces FDA Clearance of First Device

Nitiloop’s first product, the NovaCross microcatheter, has been granted FDA 510(k) clearance, the Israeli devicemaker announced Monday. The device is meant to be used in conjunction with guidewire to access the coronary or peripheral vasculature.

The devicemaker also reports positive study results from tis European multicenter clinical trial, which evaluated NovaCross’ efficacy in crossing chronic total occlusions in the coronary vasculature. The device allowed for CTO crossing in its entirety in 82 percent of patients.

The company is in the middle of another trial to support a CTO indication in the coronary vasculature.

Nitiloop was founded in 2009 to develop cardiovascular and peripheral supporting microcatheters for complex lesions and CTOs. — Jason Scott