"We are very pleased to be partnering with Merit Medical, a prominent distributor of medical devices in Europe and the U.S. that shares the same vision of addressing the clinical gaps that exist in vascular access care for hemodialysis patients," said Bluegrass CEO Gabriele Niederauer, in a statement. The partnership will also bankroll Bluegrass’ efforts to gain FDA clearance for the device.
Central venous catheters, also known as central lines, are used for the long-term delivery of fluids, drugs and nutrients. They may also be used to deliver hemodialysis. San Antonio-based Bluegrass Vascular’s Surfacer Inside-Out Access Catheter System facilitates the placement of a central line using an “inside-out” approach rather than the traditional “outside-in” method.
The device enters the body in the femoral vein and is navigated through the patient’s venous system to an exit point in the patient’s jugular vein, where the skin is pierced from the inside out. A sheath is then delivered from the outside in, and a catheter is placed.
“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 when the device earned its CE mark.
While permanent arteriovenous fistulas are the gold-standard for vascular access in hemodialysis, central lines may also be used. In 40% of cases where dialysis is delivered via central line, patients develop central venous obstruction, Bluegrass Vascular said.
"The Surfacer System is an innovative Inside-Out approach to restore access to the right internal jugular vein and to preserve treatment options in hemodialysis patients with occluded veins," stated Merit CEO Fred Lampropoulos, in the statement. "This unique approach addresses an unmet need in hemodialysis care and aligns with Merit's interventional portfolio, which includes the HeRO Graft, a complementary device designed to reduce catheter-associated complications and costs. We are very excited to bring this novel technology to market."