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Classified in: Health
Subjects: TRI, FDA

Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature


NETANYA, Israel, October 26, 2017 /PRNewswire/ --

Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Crosstm Extreme and Nova Crosstm BTK. These dedicated microcatheters are joining the Nova Crosstm product family combining innovative low profile microcatheter technology with uniquely designed Nitinol scaffold providing enhanced guidewire and microcatheter support for safer and more effective lesion crossing. The Nova Crosstm Extreme and Nova Crosstm BTK are intended to be used in conjunction with conventional guidewires to access discrete regions of the coronary and peripheral vasculature.

Recently, Nitiloop Ltd. successfully completed a pivotal study evaluating the safety and effectiveness of the NovaCrosstm CTO Microcatheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The study was conducted on 145 Subjects diagnosed with a CTO in a coronary vessel that required revascularization after a previously failed attempt. The company submitted study results and is expecting FDA feedback within the next weeks.

Dr. William Nicholson, an expert in Interventional Cardiology at York hospital, PA: "with the continuing rise in CAD prevalence and increasing complexity of lesions requiring recanalization, the Nova Crosstm Extreme is a significant new addition to our tool box for tackling these lesions.

Chana Schneider, CEO of Nit loop Ltd. commented "We are very excited at receiving FDA clearance for the Nova Crosstm Extreme and Nova Crosstm BTK, which further establishes our Nova Crosstm product family. We are encouraged by the positive medical community response to our new products bringing solution to one of the last un-met clinical need in the Cath-lab."

About Nit loop Ltd. 
Nit loop Ltd. is dedicated to the development of innovative cardiovascular and peripheral supporting microcatheters for complex lesions and Chronic Total Occlusions (CTO). Nitiloop's technology enables superior operator-controlled positioning and support in multiple vasculature applications. The company was founded by Prof. Ran Kornowski, MD, and is backed by Canceled, Access Medical Ventures and Tal Capital.

Media contact: Chanan Schneider, CEO. chanan@nitiloop.com

SOURCE Nitiloop


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