FDA grants 510(k) clearance to Corindus’s second-generation vascular robotic system
The FDA granted 510(k) clearance to the CorPath GRX for use in patients undergoing PCIs.
Corindus Vascular Robotics announced the approval in a news release Oct. 27. The CorPath GRX is the second generation of the company’s CorPath vascular robotic system, which the FDA approved in July 2012.
In October 2015, the FDA granted a 510(k) clearance to the CorPath system for use during PCIs performed via radial access. The CorPath system is the first system designed for robotic-assisted PCIs.
The CorPath GRX includes a feature that helps physicians adjust the guide catheter position during PCI procedures. It also has a new bedside unit with extended arm reach and a touchscreen display, according to the company.
Corindus said the CorPath GRX would be available in the first quarter of 2017.
During the second quarter of 2016, Corindus had $508 million in realized revenue, down from $909 million in the same time period last year. The company said the revenue decrease was due primarily to a decline in CorPath System revenue. Corindus will report third quarter results on Nov. 8.
Since the beginning of the year, Corindus has hired several executives, including Mark J. Toland as CEO in February and J. Aaron Grantham, MD, as chief medical officer in August. Toland is a former Boston Scientific executive, while Grantham is an interventional cardiologist at St. Luke's Mid America Heart Institute in Kansas City, Missouri.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.