Gore Reports First Patient Treated Using GORE® C3 Delivery System for GORE® EXCLUDER® AAA Endoprosthesis
New Medical Innovation Repositions the Future of Endovascular Repair for Abdominal Aortic Aneurysm
Flagstaff, AZ (January 11, 2011)—W. L. Gore & Associates (Gore) today reported 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 device received approval from the U.S. Food and Drug Administration (FDA) in January 2011. The first procedures were successfully performed by vascular surgeons and interventionalists at medical centers of excellence around the U.S. this week. This game-changing new technology represents a leap forward in medical innovation by allowing physicians to position the device to the specific anatomy of each individual patient.
The GORE C3 Delivery System provides the clinician with the ability to reposition the GORE EXCLUDER Device prior to final release from the delivery catheter. The added deployment control provides physicians increased confidence in treating challenging anatomies, as well as cannulation options with the ability to bring the contralateral gate to the contralateral guidewire. Once delivered into the aorta, the GORE C3 Delivery System uniquely and intuitively enables repositioning of the stent-graft. The ability to reposition the device may minimize complications that could occur if the graft needs to be repositioned after the initial deployment.
The first U.S. procedures to treat patients with an AAA using the new system were performed by:
- Michel Makaroun, MD and Robert Rhee, MD, University of Pittsburgh Medical Center (UPMC) Vascular Surgery
- Mark Fillinger, MD and William Tanski, III, MD, Dartmouth-Hitchcock Medical Center
- Claudio Schonholz, MD and Joseph Hart, MD, University of South Carolina
- Alan Lumsden, MD, Methodist Hospital
- Jon Matsumura, MD, University of Wisconsin
- David Minion, MD, University of Kentucky
According to Dr. Makaroun, Chief of the Division of Vascular Surgery and Professor of Surgery at UPMC, a 70-year-old woman with a large aneurysm and diseased aortic neck successfully received the first GORE EXCLUDER AAA Endoprosthesis with the GORE C3 Delivery System at UPMC. "The recapture mechanism worked very nicely to allow repositioning of the GORE EXCLUDER Device, a feature that will increase our confidence in treating challenging aortic neck anatomies. The deployment mechanism remains quite simple and easy to use."
Dr. Fillinger, Professor of Surgery and Director, Vascular Surgery Training Programs, Dartmouth-Hitchcock Medical Center, commented, "In our particular case, we purposely chose a patient with difficult and unusual anatomy for the GORE C3 Delivery System. The ability to reposition the device after seeing how it would accommodate the anatomy was extremely helpful, and made the case go as smoothly as possible."
Dr. Matsumura, Professor, Department of Surgery and Chairman, Division of Vascular Surgery, University of Wisconsin, added, "Our patient had difficult proximal aortic neck anatomy, and the combination of both a robotic, multi-axis imaging platform and the recently-approved reconstrainable deployment system of this EVAR device allowed us to safely treat an elderly Wisconsin woman with a minimally invasive approach. We used the unique ability to deploy an EVAR device, reconstrain and then redeploy twice in today's complex case to increase our placement accuracy beyond what would have been possible with a single deployment."
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 may minimize complications that could occur if the graft needs to be repositioned after the initial deployment. This revolutionary technology was designed to give physicians a second or third opportunity to accurately place the stent graft relative to the patient's anatomy.
More than 112,000 GORE EXCLUDER Devices have been distributed 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.
About W. L. Gore & Associates
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for three decades. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best companies to work for by Fortune magazine for the 13th consecutive year. For more information, visit goremedical.com.
Erik Clausen or Kena Hudson
Chempetitive Group for W.L. Gore & Associates
Products listed may not be available in all markets. GORE®, C3, EXCLUDER®, and designs are trademarks of W. L. Gore & Associates.