GORE ANNOUNCES FIRST PATIENT IMPLANT OF THE GORE® ASCENDING STENT GRAFT FOR TREATMENT OF ACUTE TYPE A DISSECTION IN ARISE III PIVOTAL STUDY
CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY UNITED STATES LAW TO INVESTIGATIONAL USE.
The first pivotal trial implant of an investigational endovascular stent graft for the treatment of acute Type A dissections marks a critical milestone in advancing endovascular aortic care.
FLAGSTAFF, Ariz. (December 11, 2025) — W. L. Gore & Associates' medical business (Gore) today announced the first implantation of the investigational GORE® Ascending Stent Graft in the ARISE III Trial for the treatment of an acute Type A dissection.
The implant was performed at Emory University by Brad Leshnower, MD, Site Principal Investigator and Director of Thoracic Aortic Surgery and Yazan Duwayri, MD, Study Investigator and Chief of Vascular Surgery and Endovascular Therapy.
Addressing a Critical Gap in Patient Care
Eric Roselli, MD, National Principal Investigator and Chief of Adult Cardiac Surgery at Cleveland Clinic stated, “Ascending aortic dissection is a surgical emergency that presents serious risk to a complex group of patients and can be challenging to treat."
While open repair is the current standard, there are many patients who are not candidates for open surgery or are at high risk for surgery. Medical management of Type A dissections carries a rapidly escalating risk, with mortality increasing 0.5–1 percent per hour for the first two days,1,2 reaching 60 percent in-hospital mortality.1
Dr. Roselli added, “The ARISE III study is designed to evaluate an endovascular option as a potential solution for high-risk patients with acute Type A dissection. This first implant in the pivotal trial is a vital step on the path toward expanding options for more patients.”
Dr. Leshnower, Site Principal Investigator at Emory and their Aortic Team are the first group to enroll in the ARISE III Pivotal Trial. “The ascending aorta presents a challenging environment for the use of endovascular devices due to the high blood flow rates and significant motion and angulation," remarked Dr. Leshnower, "The procedure went well, and the patient is recovering,” he continued. “Having a catheter-based solution where the patient does not have to be placed on cardiopulmonary bypass or circulatory arrest could change how we think about treating patients — and ultimately broaden treatment options for complex cases.”
About the ARISE III Clinical Trial
The ARISE III trial is a prospective, multicenter, non-randomized pivotal study approved by the U.S. Food and Drug Administration (FDA) to assess the safety and effectiveness of the investigational GORE Ascending Stent Graft in patients with acute Type A aortic dissections who are considered high risk for conventional surgery. The study will enroll up to 112 patients at multiple centers across the United States. Each enrolled patient will be closely monitored throughout the study, with follow-up assessments conducted for up to five years to evaluate safety and effectiveness outcomes over the long term.

Continuing Legacy of Aortic Innovation
ARISE III builds on Gore’s ARISE Early Feasibility Study and ARISE II Pivotal Trial, which is currently enrolling at hospitals across the United States. Together, these trials aim to develop an endovascular treatment option for various ascending aorta pathologies as an alternative to open surgery or medical management.
“The ARISE III study reflects our ongoing commitment to advancing aortic care through meaningful clinical research,” said Willy Davison, Gore's Global Aortic Business Leader. “By continuing to invest in studies that explore new treatment options across the aorta, we’re helping to expand what’s possible for physicians and patients facing complex disease.”
For more than 25 years, Gore has been a leader in aortic treatment innovation, pioneering minimally invasive treatments that have transformed care for patients with complex aortic disease. ARISE III extends this legacy, investigating new minimally invasive solutions for the ascending aorta.a
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 approximately 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion. goremedical.com
Media Contact
Jessica Moran
External Affairs
W. L. Gore & Associates, Inc.
jmoran@wlgore.com
a For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).
- Anna M. Booher, Eric M. Isselbacher, Christoph A. Nienaber, Santi Trimarchi, Arturo Evangelista, Daniel G. Montgomery, James B. Froehlich, Marek P. Ehrlich, Jae K. Oh, James L. Januzzi, Patrick O'Gara, Thoralf M. Sundt, Kevin M. Harris, Eduardo Bossone, Reed E. Pyeritz, Kim A. Eagle, The IRAD Classification System for Characterizing Survival after Aortic Dissection, The American Journal of Medicine, Volume 126, Issue 8, 2013, Pages 730.e19-730.e24, https://doi.org/10.1016/j.amjmed.2013.01.020.
- Harris KM, Nienaber CA, Peterson MD, et al. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiology. 2022;7(10):1009–1015. doi:10.1001/jamacardio.2022.2718.