Enrollment Completed in Early Feasibility Study of Gore's Excluder Thoracoabdominal Branch Endoprosthesis

June 7, 2016—Gore & Associates announced completion of enrollment in an early feasibility study evaluating its Excluder thoracoabdominal branch endoprosthesis (TAMBE) for the treatment of aortic aneurysms involving the visceral branch vessels. Gore's TAMBE device is designed to be a complete off-the-shelf solution for the treatment of this complex disease.

In Gore’s press release, the study’s National Principal Investigator Michel Makaroun, MD, commented, “The early feasibility study included two configurations of the TAMBE device. In addition to the original retrograde renal branch configuration, a new antegrade configuration allowing all of the branches to be delivered from the patient’s arm, was evaluated.” Dr. Makaroun is Chief of the Division of Vascular Surgery at the University of Pittsburgh School of Medicine in Pittsburgh, Pennsylvania.

The company noted that the antegrade configuration also features a shorter device length to optimize the fit of the design across the largest set of patient anatomies. The all-in-one system has four precannulated portals for the placement of the stent graft branches in the visceral branch vessels. Additionally, the antegrade version maintains an intuitive staged delivery system that is intended to provide physicians with the ability to reposition the graft and aid in the selective catheterization of the branches throughout the deployment process.

Mark Farber, MD, who is an investigator in the study, stated in the announcement, “Building a custom device can add a lengthy delay to time-sensitive treatments. An off-the-shelf solution from Gore makes sense as the company’s products have been designed specifically to work together to solve complex medical challenges. This enhancement to the original Gore Excluder thoracoabdominal device will help bring a minimally invasive option to the greatest number of eligible patients while reducing the complexity of the procedure.” Dr. Farber is vascular surgeon and aortic specialist in Chapel Hill, North Carolina.

Gore advised that the US Food and Drug Administration released guidance in 2013 regarding early feasibility studies, which offers a relatively new pathway to facilitate providing patients with access to safe, effective new technologies of significant importance. As cited in the guidance, the pathway enables “early clinical evaluation of devices to provide proof of principle and initial clinical safety data.” The device’s early feasibility study has now enrolled the required 10 patients, with more than half of them implanted with the latest generation of the device. This study follows an ongoing clinical study that began in Brazil in 2014, stated the company.