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 […]
Bluegrass Vascular Technologies
Bluegrass Vascular’s pivotal Surfacer trial meets primary endpoints
Bluegrass Vascular Technologies today released preliminary results from the pivotal trial of its Surface Inside-Out access catheter system, touting that the trial met both its primary and secondary endpoints. The San Antonio-based company also said that it has completed enrollment in the SAVE-US trial, recruiting 30 patients across seven U.S.-based centers. “I’m quite encouraged by […]
Bluegrass Vascular launches pivotal study for Surfacer vascular access catheter
Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August 2016; Bluegrass later […]
Merit Medical backs Bluegrass Vascular’s Surfacer ‘inside-out’ catheter
Bluegrass Vascular Technologies said today that it entered a “strategic relationship” with Merit Medical (NSDQ:MMSI) for its Surfacer “inside-out” catheter that includes an equity stake and a distribution agreement. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval […]
Bluegrass Vascular wins CE Mark for Surfacer vascular access device
Bluegrass Vascular Technologies said today that it won CE Mark approval in the European Union for its Surfacer vascular access device and plans a limited commercial launch in 7 countries there. Surfacer is designed to restore central venous access in patients with occluded veins. San Antonio-based Bluegrass Vascular, which drummed up a $4.5 million Series A round 2 years […]
Bluegrass Vascular taps ex-ArthoCare R&D chief Niederauer for CEO | Personnel Moves
Bluegrass Vascular Technologies said it named Gabriele Niederauer its new president & CEO, hard on the heels of a Series A funding round that brought in $4.5 million for its Surfacer central venous catheter.
