Bluegrass Vascular grabs CE mark for 'inside-out' central venous access system

Bluegrass Vascular picked up a CE mark for its central venous access catheter and is kicking off a limited commercial release for the device.

The Surfacer Inside-Out Access Catheter System facilitates the insertion of catheters into the central venous system, according to a statement. Also known as a central line, a central venous catheter is used for the long-term delivery of fluids, drugs, nutrition and so on. Instead of placing the catheter directly into the vein in question in the traditional “outside-in” method, the Surfacer uses an “inside-out” approach.

The device enters through the femoral vein and is navigated through the patient's venous system toward an exit target on the right internal jugular vein, “the optimal location” for a central line, according to the statement. A sheath over a guidewire is advanced toward the exit target and a needle pierces skin from the inside out. A sheath is then inserted from the outside in, and the catheter is placed. This “inside-out” delivery allows the long-term, reliable and repeated access to the central venous system, which is linked to better patient outcomes and lower cost of care, according to Bluegrass Vascular.

“No other device offers such an innovative Inside-Out method for restoring access and preserving options in patients with chronically occluded veins,” said Dr. Gürkan Sengölge, associate professor of medicine, nephrology and intensive care medicine at the Medical University of Vienna, in the statement.

“Multiple central venous occlusions can cause significant long-term morbidity,” explained Dr. John Gurley, an interventional cardiologist at the University of Kentucky Medical Center and Bluegrass founder, in the statement. “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 Surfacer will initially launch in the U.K., Austria, Germany, Italy, Belgium, the Netherlands and Luxembourg. The company will also start enrolling for an observational, postmarket study in patients with limited venous access in the upper body, or with pathology that precludes them from standard central venous access methods The company did not disclose a timeline for an FDA regulatory filing.

- here's the release