The first patient has been implanted with the Gore TAG Conformable Thoracic Stent Graft with Active Control System after being included on the Australian Register of Therapeutic Goods last month in Australia.
The first implants were performed by Professor Ian Spark at Flinders Medical Centre, Adelaide, South Australia.
Gore says that the thoracic endovascular aortic repair (TEVAR) device is the first to feature a new delivery system that provides the physician with controlled, staged deployment. The system optimises accuracy, angulation, and apposition to treat aetiologies of the descending thoracic aorta including aneurysms, transections, and acute and chronic Type B dissections.
The Gore Active Control System enhances the exceptional conformability of the stent graft; facilitating the optimised wall apposition that the Conformable Gore TAG Device is renowned for even in complex anatomies, such as acute aortic angles. The novel staged deployment feature enables the physician to refine positioning and angulate the stent graft within the body to achieve optimal placement prior to full-diameter expansion. The angulation control capability gives physicians the option to angulate the device to achieve orthogonal placement to the aortic blood flow lumen and maximise conformability and seal. These features enable physicians to more confidently perform endovascular treatment even in anatomies where tortuous vessels might historically have suggested open surgery.
“The Gore TAG Conformable Stent Graft is a reliable and trusted device that I have used for TEVAR procedures with my patients for many years,” Professor Spark comments. “The availability of the new Gore Active Control System is an exciting advancement because it significantly enhances the control I have when deploying the stent graft, making it easier to accommodate challenging anatomies. The angulation and precision deployment capabilities could decrease the risk of common complications and reduce the likelihood for future interventions that result in additional trauma for patients and costs to providers. Both the control in the delivery system and long-term benefits of the stent graft mark significant advancement for the medical community.”
The new product offering features the same time-tested stent graft as the Conformable Gore TAG Device, whose predictable outcomes have been established through its long-term freedom from reintervention (89% for aneurysms in the descending thoracic aorta and 100% for traumatic transections) through five years, and 90% dissection-related survival through one year. The device is a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent.