Gore Announces First Patient Implant in the Arise II Pivotal Study of the GORE® Ascending Stent Graft

CAUTION: Investigational device. Limited by United States law to investigational use.
The first patient implant in the ARISE II Pivotal Study evaluation of the GORE® Ascending Stent Graft represents a major milestone in the development of endovascular treatment of the ascending aorta.

FLAGSTAFF, Ariz. (December 20, 2023) — W. L. Gore & Associates (Gore) announced the first patient implantation of the GORE® Ascending Stent Graft in the ARISE II Trial, an exciting step in the development of treatments for pathologies involving the ascending aorta using endovascular repair rather than traditional open surgery.

On December 1, National Principal Investigator Eric Roselli, M.D., performed the case at Cleveland Clinic alongside Study Investigators Patrick Vargo, M.D. and Frank Caputo, M.D. The patient was identified as a candidate for the study after presenting with a fusiform aneurysm of the ascending aorta and aortic arch.

The ARISE II Study is the first multicenter pivotal study approved by the U.S. Food and Drug Administration (FDA) investigating the use of a minimally invasive endovascular device to treat the ascending aorta. The study investigates the treatment of isolated lesions as well as chronic and residual Type A dissections involving the ascending aorta. The GORE Ascending Stent Graft is designed for investigational use in combination with the GORE® TAG® Thoracic Branch Endoprosthesis.

“The treatment of the ascending aorta has long been a ‘final frontier’ in endovascular surgery. ARISE II is a significant step forward as we search for minimally invasive options that can be offered to higher risk patients,” said Eric Roselli, M.D., national principal investigator and Chief of Adult Cardiac Surgery at Cleveland Clinic.

The ARISE II Study will investigate how an endovascular stent graft, delivered via catheter, may be used to line the diseased portion of the ascending aorta as a potential alternative to open surgical repair. Endovascular technologies have been applied to other regions of the aorta to reduce the risk of complications and recovery times, but no endovascular device is currently approved for the ascending aorta.

“Our patient is recovering well. Having a minimally invasive alternative would be a significant advancement for patients not suitable for open surgery,” said Frank Caputo, M.D., vascular surgery director of the Aorta Center at Cleveland Clinic.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 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. goremedical.com

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 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.8 billion. gore.com