Bluegrass Vascular Technologies: Redefining Central Venous Access Procedures
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Gabriele Niederauer, Ph.D. CEO & President
Caused chiefly by anatomical factors, central venous obstruction is a chronic problem surgeons face when looking to establish central venous access for delivery of life-saving therapy such as hemodialysis treatment. Permanent vascular access, such as an arteriovenous (AV) fistula, is often the preferred access option for these patients as it reduces a patient’s risk of developing catheter-related complications and reduces costs. This usually takes four months or longer to mature. Since a central venous catheter (CVC) is usually required during this period, it is advantageous to use the preferable placement location of the right internal jugular (RIJ) vein as a bridge to securing such long-term access. However, studies show that more than 40 percent of patients with CVCs develop a venous obstruction, limiting access to this important treatment site and causing a cascade of serious events that may result including higher morbidity and mortality rates.
In his experience, Dr. John Gurley, co-founder of Bluegrass Vascular Technologies (Bluegrass Vascular), has found that when a vein gets blocked, physicians often seek less-desirable, left-sided vascular access. This method quickly becomes a slippery slope, eventually occluding other veins and shutting down all central venous access. To address these challenges, Dr. Gurley invented the Surfacer® Inside-Out® Access Catheter System, a state-of-the-art technology that allows surgeons to reliably and repeatedly gain central venous access from the “inside out.” Employing a minimally invasive method, the Surfacer System is inserted through the femoral vein and navigated up through the patient’s venous system with an exit point in the RIJ.
This proprietary method allows for the maturation and eventual placement of a permanent AV fistula.
The Surfacer System is not limited to dialysis patients alone but can be extended to any patient type. This novel device also finds its application in nutritional access, chemotherapy, and cardiac procedures like pacing, among others. “We want to help physicians treat patients at the first sign of the occlusion,” says Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “With the Surfacer System, physicians can safely and effectively achieve central venous access, thus providing patients with a much better clinical outcome.”
Providers can discover huge cost-savings opportunities with the Surfacer System. This is largely due to fewer catheter days and catheter-related infections, which is associated with higher patient mortality and increased costs. It’s a win-win situation for the patient, doctor, and healthcare provider. While other medical devices face enormous competition, the Surfacer System is uniquely novel. “You will find no other device like ours in the market, and to our knowledge no similar technology is in active development for commercialization,” proclaims Gabriele.
With innovation in its DNA, Bluegrass Vascular has explored several other applications of Surfacer and filed patents. The Surfacer has received CE Mark approval and is distributed in Europe by Merit Medical, a prominent global distributor of medical devices.
Currently, the company is focused on seeking FDA approval in the US. In June of this year, Bluegrass Vascular completed enrollment of its SAVE-US (Surfacer System to Facilitate Access in VEnous Occlusions–United States) pivotal trial with positive results reported. “I am grateful to our extended team for helping us achieve such significant milestones,” says Gabriele. “I am looking forward to now bringing this important technology to physicians and their patients across the U.S.”
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