View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 8, 2020updated 24 Mar 2022 8:22am

US FDA clears Nitiloop’s device to treat chronic total occlusion

The US Food and Drug Administration (FDA) has granted a 510(k) clearance for Israel-based Nitiloop’s NovaCross CTO Microcatheter, which is intended for the treatment of chronic total occlusion (CTO) prior to PTCA or stent intervention.

The US Food and Drug Administration (FDA) has granted a 510(k) clearance for Israel-based Nitiloop’s NovaCross CTO Microcatheter, which is intended for the treatment of chronic total occlusion (CTO) prior to PTCA or stent intervention.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

The device is designed to allow the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions.

Additionally, it can be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

Designed specifically for an antegrade approach, the device will enable even relatively new CTO practitioners to carry out CTO procedures safely and successfully.

Based on a nitinol scaffold deployed by the clinician preceding the CTO proximal cap, the device provides 0.014″ guidewire support and centring.

Nitiloop CEO Amir Pansky 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.”

The FDA’s clearance of NovaCross CTO Microcatheter follows a global clinical study, which enrolled 186 patients at ten centres in the US, Europe and Israel.

Study results met the primary safety endpoint of a MACE. The data confirmed the safety and efficacy of the device in enabling proximal cap crossing. The study also noted NovaCross’ success with antegrade wiring in complex lesions.

The technical success rate was high at 75.3% with a low perforation rate of 2.2%.

The device has positioned Nitiloop to tap into the $500m CTO market.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network