Endologix ChEVAS System Receives FDA Breakthrough Device Designation evtoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from evtoday.com Daily Mail and Mail on Sunday newspapers.
Share this article
Share this article
CLEVELAND, Dec. 15, 2020 /PRNewswire/ Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared technology is already being deployed in a controlled launch at Cleveland Clinic and other leading institutions in the United States. The MOTION study will be used to support the company s submission for market clearance in Europe and other international markets.
First clinically deployed overseas in 2019, and with many cases completed in the US in 2020, IOPS™ is used during endovascular aortic interventions and allows navigation and placement of catheters and guidewires with reduced dependence on X-ray fluoroscopy, to which it serves as an adjunct, providing high-definition 3-D color image guidance using electromagnetic tracking much like a miniaturized form of GPS.