Nitiloop issued the following announcement on April 7.
Nitiloop Ltd. to announce that it has received a 510(k) clearance from the U.S. Food & Drug Administration for its NovaCross™ CTO Microcatheter. The NovaCross™ CTO Microcatheter device is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions (CTO), prior to PTCA or stent intervention. It is also intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.
Used specifically for antegrade approaches
The NovaCross™ CTO device is designed solely for antegrade approach. This enables even relatively new CTO practitioners at low-volume clinics to perform antegrade CTO procedures safely and successfully. It is based on a nitinol scaffold deployed by the physician preceding the CTO proximal cap and enables superior 0.014" guidewire support and centering.
"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," said Dr. William Nicholson of Wellspan Hospital in York, PA, USA, a study investigator, commented.
High procedure success rate with low perforation rate
The approval was obtained following a global clinical study of 186 patients at 10 centers in the U.S., Europe and Israel. Study results met the primary safety endpoint of a MACE, achieving a rate of 12.3%. Secondary Mace according to SCAI definition and 3rd Universal were as low as 2.2% and 3.2%, respectively.
Technical success rate was high at 75.3% with a low perforation rate of 2.2%.
"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," said Dr. Simon Walsh, Belfast Trust hospital in UK.
Amir Pansky, Nitiloop's 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."
About Nitiloop
Nitiloop is an Israeli company, founded by Prof. Ran Kornowsky and Dvir Keren, a brilliant engineer, addressing an un-met need in vascular procedures using a novel supporting element solution.
Nitiloop's investors includes Accelmed Ventures, Access Medical Ventures, Arkin Holdings and Tal Capital.
Original source can be found here.
