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Título: Nitiloop Announces FDA 510(k) Clearance for its NovaCross™ Microcatheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature
Fecha: 18-05-2015
HERZLIYA, Israel--(BUSINESS WIRE)--Nitiloop, a medical device company dedicated to the development of cardiovascular microcatheters for complex lesions and Chronic Total Occlusions (CTO) received FDA clearance for its first product, NovaCross, which is intended to be used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature.

NovaCross functions both as a competent supporting microcatheter and as a premium low profile microcatheter on its own. NovaCross gains its supportive characteristic through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both located at its distal end.

In addition to the recent granting of FDA clearance, the company reported successful results from a First in Human (FIH) European multicenter study which looked at NovaCross’s ability to cross CTOs in the coronary vasculature. The device was successfully used in 22 patients, half of whom had undergone a prior failed CTO attempt. NovaCross enabled crossing of the CTO in its entirety in 82% of cases. At 30 days after the procedure, there were no reports of any Major Adverse Cardiac Event (MACE).

The company is currently conducting a pivotal trial in order to be cleared for a CTO indication in the coronary vasculature.

Furthermore, the first patient has been successfully enrolled in the company's FIH trial to evaluate the safety and efficacy of NovaCross in the peripheral vasculature, with a focus on Below The Knee (BTK) procedures.

Chanan Schneider, CEO of Nitiloop, commented, “We are very excited at receiving FDA clearance, which represents an important first milestone for the company. We are encouraged by the positive results from the European multicenter study on NovaCross's safety and efficacy in coronary CTOs, and look forward to replicating them in our pivotal study and FIH in the BTK segment within the coming months.”

About Nitiloop

Founded in 2009, Nitiloop is dedicated to the development of cutting edge 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 Accelmed, and Access Medical Ventures.

www.nitiloop.com

Contacts
Nitiloop Ltd.
Miriam Ivenshitz
+972-52-7222047
miriam@nitiloop.com
Fuente: endovascular.es

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