New 10-cm Gore Hybrid Vascular Graft Launched

November 14, 2012—Gore & Associates (Flagstaff, AZ) has announced the commercial availability of its new 10-cm configuration of the Gore hybrid vascular graft. The new configuration allows for access to deeper vessels, which expands the treatable patient population and offers ease of use for physicians performing vascular procedures. The device is indicated for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients with occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

According to the company, the new configuration features a 10-cm, durable, nitinol-reinforced section that is double the length of the existing 5-cm Gore hybrid vascular graft. The longer extension allows physicians to access even deeper vessels and create new access sites in anatomical locations that would have otherwise been abandoned, preserving the number of access sites available throughout a patient's long-term therapy.

The Gore hybrid vascular graft is composed of the company's expanded-polytetrafluoroethylene vascular prosthesis and has a section reinforced with nitinol, which is partially constrained to allow for easy insertion and deployment into vessels that are difficult to reach or in challenging anatomical locations. It incorporates the Carmeda bioactive surface, or CBAS, with covalently bonded heparin, resulting in a proven thromboresistant surface.

John R. Ross, MD, recently performed the first implants of the new 10-cm device for dialysis access. Dr. Ross commented in the company's press release, “The new 10-cm nitinol-reinforced section of the Gore hybrid vascular graft extends the value of the device by providing minimally invasive access to those vessels that may not have been reachable without major surgery. This preserves valuable real estate and provides an ability to revise sites that otherwise would have been abandoned. This is an especially important new option for the dialysis access population.”

Syed Hussain, MD; Jen Ash, MD; and Nabeel Rana, MD, performed the first arterial bypass procedure in the lower limb using the 10-cm configuration of the Gore hybrid vascular graft. Dr. Ash observed, “By integrating a longer nitinol-reinforced section into the design of the new hybrid graft, we are able to access even more difficult-to-reach vessels from more proximal sites, thereby expanding our patients' treatment options.”

Jean Bismuth, MD, noting that the Gore device offers several advantages for visceral and renal bypasses, commented, “This device provides a distinct advantage in renal bypasses by allowing for a rapid and reliable anastomosis, thereby minimizing renal ischemia. Additionally, in visceral and renal bypasses, it permits the surgeon to address the anastomosis and atherosclerotic disease of the vessel simultaneously, optimizing flow.”