Bluegrass Vascular’s Surfacer Venous Access System Evaluated to Facilitate Placement of CRT Device Leads

April 26, 2021—Bluegrass Vascular Technologies announced the publication of a report documenting the clinical utility of the company’s Surfacer system to gain venous access before the placement of cardiac resynchronization therapy (CRT) device leads in a patient with obstructed central veins. The report adds to the body of evidence supporting the use of the Surfacer system to gain vascular access in patients who require venous access but have occlusions and damaged vessels which preclude the ability to access the central vasculature, stated the company.

The paper by Johanna B. Tonko, MD, Stephen A. Black, MD, and Christopher A. Rinaldi, MD, was published in the open access journal, Clinical Case Reports. The case detailed in the paper was performed by Professor Rinaldi, who is a Consultant Cardiologist at Guy’s & St Thomas’ Hospital in London, United Kingdom.

As explained in the company’s press release, the Surfacer system was used in the procedure to gain central venous access that facilitated placement of three cardiac leads before the placement of an implantable CRT defibrillator in a patient with bilateral occluded brachiocephalic veins and an occluded superior vena cava. The patient had an extensive history of central venous stenosis and occlusions associated with the placement of previous CRT devices with a history of facial swelling and bilateral arm edema resulting from the above-listed conditions. Before the procedure, the patient was implanted with a leadless pacemaker system because of unsuccessful attempts to gain central venous access using a recanalization procedure.

Professor Black, who is Professor of Venous Surgery at King’s College London and Consultant Vascular Surgeon at Guy’s and St Thomas’ Hospital, commented in Bluegrass Vascular’s announcement, “The development of central venous occlusions is common in patients with permanent transvenous pacing leads and can become challenging when the need arises to replace these leads or a CRT device. The Surfacer system enabled us the ability to access the central venous system and then safely place standard transvenous leads and position a cardiac defibrillator in the preferred upper chest location for a patient who had extensive venous occlusions and failed a previous attempt to obtain central venous access.”

Bluegrass Vascular stated that the Surfacer system is designed to gain central venous access via the femoral vein. It is navigated through the patient’s venous system with an exit point in the right internal jugular vein to place a central venous catheter. The company’s inside-out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers.

The Surfacer system has received FDA de novo device clearance in the United States and CE Mark approval in Europe. The device is currently distributed in North America and Europe by Merit Medical, advised the company.