W.L.Gore receives new FDA Approval and CE Mark on two innovative technologies

Its been a banner week for the medical division of W.L. Gore & Associates.  The Flagstaff-based medical device company announced FDA approval of its GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface on November 6, 2013 followed by the announcement of receiving a CE mark for its the GORE EXCLUDER  Iliac Branch Endoprosthesis on November 7, 2013.

November 06, 2013 08:00 AM Eastern Time                                          

FLAGSTAFF, Arizona–W. L. Gore & Associates (Gore) announced today that the US Food and   Drug Administration (FDA) has approved the 25 cm GORE  VIABAHN Endoprosthesis with Heparin Bioactive Surface for the treatment of symptomatic peripheral arterial disease lesions in the  Superficial Femoral Artery (SFA). The new 25 cm endoprosthesis is the  longest length stent-graft available, and is designed to cover  long-segment lesions in the SFA, potentially reducing the need for   multiple devices.

“The GORE VIABAHN Endoprosthesis is the only device of its kind approved  for both the SFA and iliac artery. The availability of the longer length  25 cm device aligns well with the findings of multiple studies utilizing       the endoprosthesis, particularly the VIASTAR randomized trial”

The FDA approval of the 25 cm device was supported by evidence from a  multicenter European trial. Patients enrolled in the study had lesion  lengths ranging from 20 cm to 40 cm, with a mean length of 26.5 cm. Of all patients enrolled, 92.9 percent had total occlusions of the SFA.  One-year data demonstrated a freedom from target lesion  revascularization of 78.2 percent. In addition, the GORE VIABAHN Device  exhibited no fractures at 12 months.

The 25 cm study results supplement data from a physician-sponsored  investigational device exemption (IDE) trial conducted previously. “We have been awaiting the approval of the 25 cm [GORE VIABAHN Device] since our study directly comparing the [GORE VIABAHN] Stent-graft as an endoluminal bypass in the SFA to open femoral popliteal bypass of the SFA was completed,” said Dennis Gable, MD, vascular surgeon at The Heart Hospital Baylor Plano in Plano, Texas. “Our results demonstrated no difference in primary patency or limb salvage out to four years when  comparing the two treatment modalities—even with a mean stented length of 25.6 cm in the [GORE VIABAHN Device] arm. Our study results are supported by the similar outcomes of the European data and show that treatment of truly long lesions can now successfully be accomplishedwith only one stent device with excellent results; a true advance for patients in the treatment of SFA disease.”

The unique stent-graft design of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface consists of a durable, reinforced, biocompatible, ePTFE liner attached to an external nitinol stent structure that acts as a barrier to in-stent restenosis. The device is  available in configurations that are compatible with 0.035” or 0.018/0.014” wire platforms. The device also incorporates the Heparin Bioactive Surface, which utilizes a proprietary end-point covalent  immobilization of heparin to the surface of the endoprosthesis. This proprietary surface technology is intended to provide a thromboresistant  surface through sustained heparin bioactivity.

“The GORE VIABAHN Endoprosthesis is the only device of its kind approved for both the SFA and iliac artery. The availability of the longer length 25 cm device aligns well with the findings of multiple studies utilizing the endoprosthesis, particularly the VIASTAR  randomized trial,” said Ben Beckstead, Gore Peripheral Interventional Business Leader.

In the recently published VIASTAR Trial, the performance of the GORE VIABAHN Device in long-segment SFA disease was compared to that of bare metal stents in a randomized head-to-head fashion. The mean lesion length was 19 cm in the GORE VIABAHN Device arm and 17.3 cm in the bare metal stent arm, with 79 percent and 70 percent chronic total occlusions in each arm, respectively. The primary patency rate at one year was 78  percent for the GORE VIABAHN Device and 54 percent for bare metal stents. In lesions that were at least 20 cm in length, the patency rate   was 73 percent in the GORE VIABAHN Device arm and 33 percent in the bare  metal stent arm.  LEARN MORE


November 07, 2013 03:00 AM Eastern Time                                          

FLAGSTAFF, Ariz.–W. L. Gore & Associates (Gore) today announced the GORE EXCLUDER  Iliac Branch Endoprosthesis, the first complete, fully engineered system (Gore designed iliac branch and internal iliac components) intended for endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms, has received CE Mark. The first patient procedures in Europe were successfully completed by vascular surgeons Piergiorgio Cao, MD,  Chief of Vascular Surgery at San Camillo Hospital, Rome, Italy, Mo Hamady, MD, Consultant Interventional Radiologist at St. Mary’s Hospital, London, and Mr. Michael Jenkins, Consultant Vascular Surgeon and Clinical Lead at St. Mary’s Hospital, London.

“This new product reflects the needs of today’s vascular surgeons, and is driven by Gore’s commitment to delivering innovation by design.”

This new device — used in conjunction with GORE EXCLUDER AAA Endoprosthesis components to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external  iliac and internal iliac arteries — is built on Gore’s proven technology platform and designed using the same durable, expanded  polytetrafluoroethylene (ePTFE) graft.

“Gore’s dedicated components for iliac artery repair provide the first complete low profile system for managing common iliac artery aneurysms.  The procedure is simple and straightforward due to the pre-cannulated  branch and bi-femoral delivery system,” said Dr. Hamady.   LEARN MORE


W.L. Gore & Associates, Inc. was named the 2013 Arizona Bioscience Company of the Year by the Arizona Bioindustry Association.  To see the video and learn more about Gore, click here.

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