Terumo Aortic Launches EXTEND Global Postapproval Study for Thoraflex Hybrid

June 13, 2023—Terumo Aortic announced the launch of the EXTEND global postapproval study for the company’s Thoraflex Hybrid frozen elephant trunk (FET) device. In April 2022, the company announced FDA approval of the device for the treatment of patients with complex aortic arch disease. The Thoraflex Hybrid FET device was approved in Europe in 2012.

The study is a prospective, multicenter, nonrandomized, single-arm, all-comers, postmarket study of Thoraflex Hybrid and Terumo Aortic’s RelayPro nonbare stent (NBS).

According to the company, the aim of EXTEND is to evaluate the Thoraflex Hybrid device on its own in a real-world environment and in combination with the RelayPro NBS graft for the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.

The global EXTEND study will include up to 55 centers at leading health care institutions in Europe and North America. A minimum of 200 patients will be enrolled with a follow-up period of 10 years. A minimum of 65 patients will have a RelayPro NBS distal extension implanted in addition to Thoraflex Hybrid.

The first patient in the EXTEND study was enrolled by Christian Shults, MD, a cardiac surgeon at MedStar Washington Hospital Center in Washington, DC.

The study’s North American Principal Investigator is Joseph Bavaria, MD, who is Vice Chief, Division of Cardiovascular Surgery at the University of Pennsylvania in Philadelphia, Pennsylvania.

The European Principal Investigator is Martin Czerny, MD, who is a consultant cardiovascular surgeon at University Hospital Freiburg in Germany.

In Terumo Aortic’s press release, Dr. Czerny commented, “The EXTEND study is an exciting opportunity to gather long-term follow-up data on grafts used to treat a wide range of aortic pathologies while demonstrating the continued safety and performance of the Thoraflex Hybrid device alone and in combination with the RelayPro NBS device.”

Dr. Bavaria added, “We look forward to contributing to this unique global study and collecting long-term data on Thoraflex Hybrid and RelayPro in highly complex aortic interventions. To date, the majority of studies on hybrid grafts are limited to short-term follow-up, and this study will be a significant step toward understanding long-term outcomes and the benefits for patients.”