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 ago to back its CE Mark bid, said it plans to put Surfacer on the market in the U.K., Germany, Austria, Italy, Holland, Belgium and Luxembourg. The company said it’s also set to begin a post-market registry study of the device.
“This is a major milestone both for our company and for patients with occlusive disease,” president & CEO Gabriele Niederauer said in prepared remarks. “After successful use of our device in initial commercial cases and previously under Germany’s compassionate use program, we are eager to commercialize the system in Europe and meet the clinical demand from physicians treating patients with occluded central veins.”
“Multiple central venous occlusions can cause significant long-term morbidity,” added founder & inventor Dr. John Gurley of the University of Kentucky Medical Center. “The novel inside-out approach is an innovative and simple method that restores and preserves right-sided venous access despite chronic occlusion and retains the viability of other existing central veins.”
“The launch of the Surfacer System in Europe brings a much-needed solution to a growing population of patients requiring vascular access for vital treatments and who currently have limited options due to obstructed upper body access,” said Dr. Gürkan Sengölge of Austria’s Medical University of Vienna. “I was very pleased with my 1st commercial use of the Surfacer System. No other device offers such an innovative Inside-Out method for restoring access and preserving options in patients with chronically occluded veins. Based on my initial experience, I am confident that the Surfacer System will change the standard of care going forward.”
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