FDA Clears Nitiloop's Nova Cross Extreme and Nova Cross BTK Microcatheters
October 26, 2017—Nitiloop Ltd. announced US Food and Drug Administration (FDA) clearance for the company's Nova Cross Extreme microcatheter and Nova Cross BTK (below-the-knee) microcatheter. The devices are intended to be used in conjunction with conventional guidewires to access discrete regions of the coronary and peripheral vasculature.
According to the company, the Nova Cross products combine low-profile microcatheter technology with the company's nitinol scaffold design to provide enhanced guidewire and microcatheter support for safer and more effective lesion crossing.
Nitiloop is an Israel-based medical device company dedicated to the development of cardiovascular and peripheral microcatheters for complex lesions and chronic total occlusions (CTOs).
The company recently completed a pivotal study evaluating the safety and effectiveness of the NovaCross CTO microcatheter when used to facilitate crossing of CTO lesions in coronary arteries. The study was conducted on 145 patients diagnosed with a CTO in a coronary vessel that required revascularization after a previously failed attempt. Study results were submitted to the FDA, advised Nitiloop.