Medical device firm Nitiloop has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its microcatheter, NovaCross.
The company has developed NovaCross to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature.
Nitiloop CEO Chanan Schneider said: "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 multicenter study on NovaCross’s safety and efficacy in coronary CTOs, and look forward to replicating them in our pivotal study and FIH in the BTK segment within the coming months."
Nitiloop reported results from a First in Human (FIH) European multicenter study, which demonstrated NovaCross’s ability to cross chronic total occlusions (CTOs) in the coronary vasculature.
Currently, the company is carrying out a pivotal trial for NovaCross, in a bid to obtain approval for a CTO indication in the coronary vasculature.
In addition, the company successfully enrolled the first patient in its FIH trial to assess the safety and efficacy of NovaCross in the peripheral vasculature, allowing the device for use in below the knee (BTK) procedures.