Gore Receives European CE Mark Approval For Next Generation Conformable GORE TAG(R) Thoracic Endoprosthesis

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Regulatory Affairs / Drug Approvals
Article Date: 12 Nov 2009 - 0:00 PST

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W.L. Gore & Associates (Gore) announced that it has received European CE Mark approval for the next generation GORE TAG® Thoracic Endoprosthesis. The device is available in an expanded portfolio of sizes to meet a broad range of patient needs and was engineered to treat multiple etiologies including thoracic aortic aneurysms (TAAs), traumatic aortic transections and thoracic aortic dissections.

Prof. Dittmar Böckler at the University of Heidelberg in Heidelberg, Germany, and Dr. Thomas Larzon at the Orebro University Hospital in Orebro, Sweden, were the first European physicians to implant the next generation Conformable GORE TAG Thoracic Endoprosthesis. Prof. Dittmar Böckler, vascular surgeon from the University of Heidelberg said, "The Conformable GORE TAG Device achieved excellent wall apposition and conformed to the thoracic aorta, thus allowing us to treat more patients with individual anatomies."

Design enhancements to the next generation Conformable GORE TAG Thoracic Endoprosthesis include a modified stent frame, repositioned gold bands, and optimized graft film layers for improved conformability in tortuous anatomies. The device will be available in diameters of 21 - 45 mm, allowing for the treatment of patients with aortic diameters of 16 - 42 mm. Tapered device configurations will also be available. In addition, the device now offers clinicians a modified device delivery catheter that is designed for enhanced trackability and deliverability to the target. The modified GORE TAG Device delivery catheter is a simple, single-step deployment system engineered to optimize placement and control. The novel sheathless delivery catheter provides flexibility for navigating tortuous anatomy and low deployment forces.

"The GORE TAG Device has remained the leading option for less invasive treatment of thoracic aneurysms and lesions with a proven safety record, which is supported by more than ten years of worldwide clinical data," said David Abeyta, Aortic Business Unit Leader at Gore. "Our next generation Conformable GORE TAG Device was engineered for flexibility and conformability in tortuous anatomy to provide our customers with endovascular innovations that meet the needs of individual patients. This device represents yet another technological advancement from Gore in our effort to provide clinicians in Europe with life-saving, minimally invasive solutions."

Source
W. L. Gore & Associates