Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system.
The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that limit central venous access through conditional methods. The system could be especially beneficial for people who rely on dialysis but have obstructed vein problems.
San Antonio-based Bluegrass touts the Surfacer system as the first FDA-cleared device to facilitate upper body central venous access in the targeted patient population, thanks to the results of its Save-Us trial. The company reported that 90% of the 30 people enrolled met both the primary and secondary efficacy endpoints, despite a complex patient population, while no adverse events related to the device were reported.
In a news release, Save-Us principal investigator and interventional radiologist at St. Joseph Hospital in Orange, Calif. Dr. Mahmood Razavi said the safe and effective approach of the Surface system offers a solution to an unmet clinical need. Peoplewho need life-saving therapies like dialysis, but have limited options because of venous obstructions, now have a new option, Razavi added.
“For the first time ever, physicians in the U.S. can offer patients a reliable and repeatable solution to treat central venous obstructions and restore access to the right internal jugular vein – the preferred access site,” Bluegrass president & CEO Gabriele Niederauer said in the news release. “Through our experience in Europe and other international sites, the Surfacer system has consistently demonstrated a positive clinical impact. We are eager to bring the Surfacer system and its important benefits to patients in the U.S.”
Bluegrass said it will make the Surfacer system available in select U.S. centers in the coming months, having already made it available in Europe, Canada, Singapore and the Middle East.
Original Article: (https://www.massdevice.com/bluegrass-vascular-technologies-wins-de-novo-nod-for-inside-out-vascular-access-catheter/)
