Michael Barbella, Managing Editor05.07.21
Doctors in New York and Texas have successfully completed their first cases using W. L. Gore & Associates Inc.'s U.S. Food and Drug Administration (FDA)-approved GORE EXCLUDER Conformable AAA Endoprothesis with ACTIVE CONTROL System. Cases were successfully performed by Robert Rhee, M.D. with Mahmoud Almadani, M.D., in Brooklyn, N.Y., and by Gustavo Oderich, M.D. with Naveed Saqib, M.D., in Houston, Texas.
"The addition of the GORE EXCLUDER Conformable Device to the GORE EXCLUDER Device family allows physicians to select the best device for their patient's anatomy," said Dr. Robert Rhee, chief of Vascular and Endovascular Surgery, Maimonides Medical Center in Brooklyn, national principal investigator. "Gore has combined a novel stent design, device conformability and an enhanced delivery system to give physicians even more control when we need it most."
The GORE EXCLUDER Conformable AAA Endoprosthesis, approved by the FDA in December, 2020, is an endovascular aneurysm repair (EVAR) solution which saw 100 percent technical success, 100 percent freedom from device related serious adverse events, and 100 percent patency in the first clinical trial sub-study.1 The study enrolled 80 patients who completed one-year follow-up and experienced zero type I or III endoleaks, migrations, ruptures, conversions to open repair, stent fractures or limb occlusions. Enrollment in the high neck angulation sub-study is on-going.
This delivery system is the first to feature an optional angulation control, giving implanting surgeons the ability to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen, and to maximize the conformability and seal of the device.
"The GORE EXCLUDER Conformable Device is another step forward in addressing areas of clinical need with a unique combination of conformability, precision and repositioning capabilities" said Dr. Gustavo Oderich, professor and chief of Vascular and Endovascular Surgery, McGovern Medical School at UTHealth, Houston.
Gore is committed to the ongoing evaluation of the device performance and seeking potential expansion of approved indications based on data that continues to be collected from the remaining arm of the clinical study.
Reference
1 Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. NLM Identifier: NCT02489539. Published July 3, 2015. Updated June 16, 2020. Accessed November 17, 2020. https://clinicaltrial.gov/ct2show/NCT02489539
"The addition of the GORE EXCLUDER Conformable Device to the GORE EXCLUDER Device family allows physicians to select the best device for their patient's anatomy," said Dr. Robert Rhee, chief of Vascular and Endovascular Surgery, Maimonides Medical Center in Brooklyn, national principal investigator. "Gore has combined a novel stent design, device conformability and an enhanced delivery system to give physicians even more control when we need it most."
The GORE EXCLUDER Conformable AAA Endoprosthesis, approved by the FDA in December, 2020, is an endovascular aneurysm repair (EVAR) solution which saw 100 percent technical success, 100 percent freedom from device related serious adverse events, and 100 percent patency in the first clinical trial sub-study.1 The study enrolled 80 patients who completed one-year follow-up and experienced zero type I or III endoleaks, migrations, ruptures, conversions to open repair, stent fractures or limb occlusions. Enrollment in the high neck angulation sub-study is on-going.
This delivery system is the first to feature an optional angulation control, giving implanting surgeons the ability to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen, and to maximize the conformability and seal of the device.
"The GORE EXCLUDER Conformable Device is another step forward in addressing areas of clinical need with a unique combination of conformability, precision and repositioning capabilities" said Dr. Gustavo Oderich, professor and chief of Vascular and Endovascular Surgery, McGovern Medical School at UTHealth, Houston.
Gore is committed to the ongoing evaluation of the device performance and seeking potential expansion of approved indications based on data that continues to be collected from the remaining arm of the clinical study.
Reference
1 Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. NLM Identifier: NCT02489539. Published July 3, 2015. Updated June 16, 2020. Accessed November 17, 2020. https://clinicaltrial.gov/ct2show/NCT02489539
