The US Food and Drug Administration (FDA) has granted a 510(k) clearance for Israel-based Nitiloop’s NovaCross CTO Microcatheter, which is intended for the treatment of chronic total occlusion (CTO) prior to PTCA or stent intervention.
The device is designed to allow the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions.
Additionally, it can be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
Designed specifically for an antegrade approach, the device will enable even relatively new CTO practitioners to carry out CTO procedures safely and successfully.
Based on a nitinol scaffold deployed by the clinician preceding the CTO proximal cap, the device provides 0.014″ guidewire support and centring.
Nitiloop CEO Amir Pansky said: “We are delighted with the new approval that enables us to offer our device in a $500m market with only a few players. We are constantly expanding our product portfolio, and it now consists of three different catheters, indicated for peripheral and coronary procedures.”
The FDA’s clearance of NovaCross CTO Microcatheter follows a global clinical study, which enrolled 186 patients at ten centres in the US, Europe and Israel.
Study results met the primary safety endpoint of a MACE. The data confirmed the safety and efficacy of the device in enabling proximal cap crossing. The study also noted NovaCross’ success with antegrade wiring in complex lesions.
The technical success rate was high at 75.3% with a low perforation rate of 2.2%.
The device has positioned Nitiloop to tap into the $500m CTO market.