FLAGSTAFF, Ariz. (January 6, 2021) — Today, W. L. Gore & Associates, Inc. (Gore) announces U.S. Food and Drug Administration (FDA) has granted regulatory approval for the new GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System, a new EVAR solution which builds on the proven clinical performance of the GORE® EXCLUDER® AAA Device and incorporates design elements similar to the Conformable GORE® TAG® Stent Graft.
The data submitted to the FDA included 100% technical success, 100% freedom from device related serious adverse events and 100% patency.
Robert Rhee, M.D.
Chief of Vascular and Endovascular Surgery
The GORE® EXCLUDER® Conformable Device debuts the GORE® ACTIVE CONTROL System into the abdominal aorta and is comprised of a conformable stent graft, enhanced device positioning, and optional angulation control. This delivery system is the first to feature angulation control, giving physicians the option to angle the device to achieve orthogonal placement to the aortic blood flow lumen to maximize conformability and seal.
“I am impressed with how well the device performed in the clinical study and appreciate the efforts of the investigators who contributed to this milestone,” said Robert Rhee, M.D., Chief of Vascular and Endovascular Surgery, Maimonides Medical Center in Brooklyn, New York, National Principal Investigator.
“The data submitted to the FDA included 100% technical success, 100% freedom from device related serious adverse events and 100% patency.” The data Dr. Rhee referenced is from the first sub-study of the clinical trial, which enrolled 80 patients who completed 1-year follow-up. The second sub-study of the trial will evaluate the device in proximal aortic neck angles of >60 to 90 degrees and aortic neck lengths of 10mm or greater. Enrollment in this sub-study is on-going.
"Additionally, there were no Type I/III endoleaks, migration, rupture, conversion to open repair, stent fractures or limb occlusions and 98.6% of patients showed freedom from aneurysm enlargement.” said Dr. Rhee. “I am confident this device will expand EVAR treatment options for patients diagnosed with abdominal aortic aneurysms. The GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL System received CE Mark in 2016.
The GORE EXCLUDER Device family also includes the GORE® EXCLUDER® AAA Endoprosthesis featuring C3® Delivery System and GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE). The latter is the only FDA approved iliac branch device and is indicated for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The IBE is to be used in conjunction with the GORE EXCLUDER AAA Endoprosthesis and has exceeded 20,000 implants globally since receiving CE Mark in 2013.
“We remain committed to evaluating the performance of this device and seeking expanded indications with data from the remaining arm of this clinical study,” stated Benjamin Beckstead, Gore Vascular Category Leader. “With the FDA approval of the new GORE EXCLUDER Conformable AAA Endoprosthesis with ACTIVE CONTROL System, Gore is continuing to innovate and grow its family of endovascular products to treat AAAs. We look forward to this new technology being available to U.S. physicians and their patients in the coming months.”
The GORE EXCLUDER Device family includes the GORE EXCLUDER AAA Endoprosthesis, which represents over 20 years of worldwide experience and nearly 400,000 patients treated*, a history unmatched by currently available AAA stent grafts. The GORE EXCLUDER Conformable Device leverages the limb design of the GORE EXCLUDER Device which has demonstrated exceptional clinical performance as evidenced by 0.7% limb occlusion through 5-year follow-up.† The limbs, a unique combination of proprietary ePTFE graft material and a fully supported, nested, nitinol stent, are designed to prevent kinking and occlusion. For additions to its branched portfolio, Gore continues to conduct studies on new technologies to treat other aortic disease states.
About Gore
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 11,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.8 billion. For more information, visit gore.com.
* Based on the number of Trunk-Ipsilateral Legs distributed.
† GREAT. n = 3,273. To calculate the overall event rates from procedure through end of study period, all subjects who could have had events, regardless of length of follow-up, were included. For outcome data, GREAT only collects site reported serious adverse events.
For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives.
For more information, visit goremedical.com.