FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System
The company reports that the Surfacer System will be available in select U.S. centers in the coming months. The system received CE Mark in 2016 and is available in Europe, Canada, Singapore and the Middle East.
“I’m quite encouraged by the highly positive results demonstrated by the Surfacer System,” stated Mahmood Razavi, MD, Interventional Radiologist at St. Joseph Hospital in Orange, California and lead principal investigator of the SAVE-US study.
4/15/19: The Surfacer Inside-Out Access Catheter System is indicated for obtaining central venous access to facilitate catheter insertion in patients with diminished upper body access. Bluegrass Vascular is a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures.
Bluegrass Vascular Technologies Completes Enrollment Of International Post-Market SAVE Registry With Early Positive Results
In addition, the company also announced expanded patient enrollment and study sites in the SAVE-US (Surfacer System to Facilitate Access in VEnous Occlusions – United States), a pre-market investigational device exempt study.