April 7, 2020
FDA Clears Nitiloop’s NovaCross CTO Microcatheter
April 7, 2020—Nitiloop Ltd. announced that it has received FDA 510(k) clearance for its NovaCross chronic total occlusion (CTO) microcatheter. Nitiloop is based in Israel.
The device is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including CTOs, before stent interventions or percutaneous transluminal coronary angioplasty. It is also intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral and coronary vasculature and for guidewire exchange.
According to the company, the NovaCross CTO device is designed solely for the antegrade approach, which enables even relatively new CTO practitioners at low-volume clinics to safely and successfully perform antegrade CTO procedures. The design is based on a nitinol scaffold deployed by the physician preceding the CTO proximal cap and enables 0.014-inch guidewire support and centering.
The company advised that FDA approval was obtained with support from a global clinical study of 186 patients at 10 centers in the United States, Europe, and Israel. The study met the primary safety endpoint of major adverse cardiovascular events (MACE) with a rate of 12.3%. Rates of secondary MACE according to the Society for Cardiovascular Angiography and Interventions definition and the Third Universal definition were was 2.2% and 3.2%, respectively. The technical success rate was 75.3% with a perforation rate of 2.2%.
Study investigator William Nicholson, MD, of Wellspan Hospital in York, Pennsylvania, commented in the company’s announcement, “The NovaCross is a significant new addition to our CTO toolbox for tackling lesions. It improves our antegrade success rate while minimizing the risk of perforation. The device is simple and safe and can be easily adopted by either high-volume or low-volume cath lab clinicians.”
Simon Walsh, MD, added, “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.” Dr. Walsh is from Belfast Trust Hospital in Belfast, Northern Ireland, United Kingdom.