By NS Medical Staff Writer, NS Medical Devices
Nitiloop, an Israeli company, has received the US Food and Drug Administration 510(k) approval for its NovaCross CTO Microcatheter.
The NovaCrossCTO Microcatheter is designed to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions (CTO), prior to PTCA or stent intervention.
In addition, the device is also used in combination with a steerable guidewire to access distinct regions of the coronary and peripheral vasculature and for guidewire exchange.
Nitiloop Amir Pansky CEO 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.”
Nitiloop said that its NovaCross CTO device is designed for antegrade approach to enable relatively new CTO practitioners at small clinics to perform antegrade CTO procedures safely.
The company has designed the device based on a nitinol scaffold deployed by the physician preceding the CTO proximal cap and enables superior 0.014″ guidewire support and centering.
The FDA approval was supported by a global clinical study of the microcatheter on 186 patients across 10 centers in the US, Europe and Israel.
The results of the study have reached the primary safety endpoint of a MACE, achieving a rate of 12.3%.
Simon Walsh from Belfast Trust hospital said: “The NovaCross device has now completed evaluation in first-in-human and a pivotal FDA approval trial.
“The data confirm that the device is safe and efficacious, facilitating proximal cap crossing and success with antegrade wiring in complex lesions.
“The NovaCross gives added support for wiring and does not require added training for physician use.”