The Surfacer Inside-Out access catheter system (Bluegrass Vascular Technologies) has been successfully used in its first clinical case. The patient in question was facing life-threatening complications from end-stage renal disease.
The procedure was performed under Germany’s “compassionate use” program, which grants access to physicians for use of medical devices not yet CE mark-approved in Europe, particularly in Germany, for patients who are diagnosed with advanced diseases and fail to respond to existing treatment options. The procedure was performed by Eckehard Mündlein, director of the Dialysis and Vascular Access Center at Ortenau Hospital in Offenburg, Germany.
“Earlier this month we successfully performed a haemodialysis catheter replacement procedure utilising the Surfacer system which allowed a patient with complete obstruction of all four central veins facing life-threatening complications from end-stage renal disease to continue to receive life-sustaining dialysis therapy,” states Mündlein. “The Surfacer system enabled us to restore repeatable access to the patient’s right internal jugular vein (RIJ), which had been obstructed by numerous surgical interventions. The ability to insert a catheter in this preferential anatomical location, will allow this patient to continue dialysis therapy while also preserving the remainder of the patient’s vasculature.”
Gabriele Niederauer, chief executive officer and president of Bluegrass Vascular Technologies says, ” The Surfacer System ensures that valuable venous real estate will not be depleted, thus avoiding damage to other veins, and in patients with totally occluded veins, providing an alternative to extremely invasive and costly surgery for catheter placement.”
The Surfacer system is designed to permit physicians the ability to reliably gain central venous access from the inside out by inserting the Surfacer system through the femoral vein and navigating it up through the patient’s venous system with an exit point in the RIJ vein, the optimal location for placing a central venous catheter. The proprietary Inside-Out approach restores and preserves venous access while retaining the viability of existing central veins. This should allow for the placement and maturation of permanent arteriovenous access options.
Bluegrass Vascular Technologies has applied for CE mark certification, and plans to commercialise the Surfacer system in Europe in the upcoming months. In addition, the company recently received International Organization for Standardization (ISO) 13485:2003 certification.