W. L. Gore & Associates (Gore) today announced the first clinical uses of the GORE® C3 Delivery System to deploy the GORE EXCLUDER AAA Endoprosthesis as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm (AAA). The GORE C3 Delivery System provides surgeons and interventionalists with added deployment control with the ability to reposition the GORE EXCLUDER Device, increased confidence while treating challenging anatomies, and cannulation options with the ability to bring the contralateral gate to the contralateral guidewire.
“The GORE C3 Delivery System for the GORE EXCLUDER Device has shown a high level of performance in the first clinical uses and that it will provide surgeons added confidence and control during deployment of endovascular procedures”
Dr. Eric Verhoeven, Chief, Department of Vascular and Endovascular Surgery, at Klinikum Süd in Nürnberg, Germany, performed the first procedure to treat a patient with an abdominal aortic aneurysm (AAA) using the new system. Additional procedures were performed subsequently by Dr. Piotr Kasprzak, Leader of Vascular Surgery, at Klinikum der Universität in Regensburg, Germany and Dr. Hans-Joachim Florek, Chief of Vascular Surgery, at Elbe-Weiβeritztal Kliniken in Dresden (Freital), Germany.
According to Dr. Verhoeven, "After three years of collaborative development with other physicians and Gore, it was an exciting moment to use the GORE C3 Delivery System. It was both an honor and a pleasure to do the first implant using this system. I am proud to be part of the development of the GORE C3 Delivery System for the GORE EXCLUDER Device, for it will provide physicians added control during deployment."
The GORE C3 Delivery System provides physicians with a proven stent graft and delivery options that they never had before. The GORE EXCLUDER Device remains virtually unchanged, maintaining the same low delivery profile and flexibility on catheter that facilitates access and passage through narrow and tortuous anatomies. Once delivered into the aorta, the GORE C3 Delivery System uniquely and intuitively enables repositioning of the stent graft during the procedure. The ability to reposition the device can minimize complications that could occur were the graft to be positioned incorrectly during the initial deployment. This game-changing technology was designed to give physicians a second or third opportunity to accurately place the stent graft relative to the patient's anatomy.
Dr. Verhoeven continued, "We specifically selected our initial patients with short or angulated necks, or with difficult iliac anatomy, to be able to use the graft to its full extent. In the four patients treated with the GORE C3 Delivery System, we repositioned the graft twice for level and for rotational orientation, to maximize the sealing zone in the aortic neck and facilitate cannulation of the contralateral limb. In the other two patients repositioning was unnecessary because either the proximal position was perfect after the initial deployment, or cannulation was immediately successful. However, having the option to reposition the GORE EXCLUDER Device enabled us to treat these challenging anatomies with added confidence during our initial deployment. Overall, the GORE C3 Delivery System worked as it was designed and provided unparalleled control while remaining intuitive and easy to use."
"The GORE C3 Delivery System for the GORE EXCLUDER Device has shown a high level of performance in the first clinical uses and that it will provide surgeons added confidence and control during deployment of endovascular procedures," said David Abeyta, Aortic Business Unit Leader at Gore. "The GORE C3 Delivery System is an excellent example of Gore's unceasing commitment, in collaboration with the endovascular community, to work toward the improvement of patient care."
More than 100,000 GORE EXCLUDER Devices have been implanted in patients worldwide since 1997. The GORE EXCLUDER AAA Endoprosthesis is constructed of a durable ePTFE bifurcated graft with an outer self-expanding nitinol support structure which provides both device flexibility and material durability. The function of the endoprosthesis is to internally reline the abdominal aorta, including the bifurcation, and isolate the aneurysm from blood circulation. The device is inserted by a catheter-based delivery technique through small incisions in the patient's legs.
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