Enrollment Begins for Study of Bluegrass Vascular's Surfacer Inside-Out Access Catheter

December 9, 2011—Bluegrass Vascular Technologies, Inc. (Lexington, KY) announced the commencement of patient enrollment in the first clinical study of its Surfacer inside-out access catheter system. The prospective single-center feasibility study will evaluate the safety and effectiveness of the Surfacer in up to 10 patients who have upper extremity venous occlusion. Adrian Ebner, MD, is the study's Principal Investigator. Bluegrass Vascular Technologies expects to announce the study's findings in 2012.

According to the company, the Surfacer allows physicians to use an inside-out approach to gain venous access. A guidewire is inserted through the femoral vein and navigated through the torso with an exit point in the jugular or subclavian vein. A standard central venous catheter or dialysis catheter can then be placed in the occluded vessel using an “outside-in” approach. The Surfacer was developed to provide a safe and simple long-term access alternative to surgery for patients who have upper extremity venous occlusions that make veins impenetrable by a guidewire or standard access techniques.

“Our early experience with the Surfacer has shown it to hold significant promise for regaining access in patients whose veins have become totally compromised with occlusion, thereby limiting their ability to receive critical vascular access therapies such as dialysis and intravenous chemotherapy,” commented Dr. Ebner. “The Surfacer's unique inside-out approach is minimally invasive and simple to perform, and it has demonstrated the ability to reestablish access in the first series of study patients. Based on these early clinical results, I believe the Surfacer has the potential to ultimately eliminate the undue risk and associated cost of more-invasive procedures that, until now, have been the only alternative for regaining access.”