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Terumo Aortic today announced the launch of the company’s global Post-Approval Study (PAS) known as EXTEND for Thoraflex Hybrid, the only Frozen Elephant Trunk (FET) device approved by the US Food and Drug Administration (FDA) for the treatment of patients with complex aortic arch disease.

This study is a prospective, multi-center, non-randomized, single arm, all-comers, post-market study of Thoraflex Hybrid and RelayPro Non-Bare Stent (NBS).

The aim of the EXTEND study is twofold: to evaluate the Thoraflex Hybrid device on its own in a “real-world” environment, and also 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.

This global study will include up to 55 centers at leading healthcare 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.

Christian Shults MD, Cardiac Surgeon at MedStar Washington Hospital Center, enrolled the first subject. 

European Principal Investigator, Martin Czerny MD, Consultant Cardiovascular Surgeon, University Hospital Freiburg, Germany, 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.”

North American Principal Investigator, Joseph Bavaria MD, Vice Chief, Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia 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 towards understanding long-term outcomes and the benefits for patients.”

Jeffrey Mifek, Global Vice President, Clinical and Medical Affairs at Terumo Aortic said: “We are in the fortunate position to study this combination as Thoraflex Hybrid is the only FDA approved hybrid graft in the US for Frozen Elephant Trunk procedures and RelayPro NBS is the only endovascular graft FDA approved to extend Thoraflex Hybrid. It is anticipated that the data collated in the coming years will provide the global surgical community with insights on extension devices helping to revolutionize future treatment options for patients. Terumo Aortic is committed to building clinical evidence that supports the entire aortic solutions portfolio.”

Thoraflex Hybrid and RelayPro are integral to Terumo Aortic’s market leading portfolio; the company is the only provider of aortic solutions for endovascular, hybrid and surgical procedures, enabling physicians to optimize their treatment of aortic patients.


About Terumo Aortic

At Terumo Aortic, we partner with our customers to revolutionize aortic care. We deliver innovation, versatility and precision with the broadest range of solutions that can be personalised for every patient. We are further complementing our implantable device portfolio through the development of digital technologies.

Notes to Editors

•    Terumo acquired Vascutek Ltd. in 2002 and Bolton Medical Inc. in 2017
•    Terumo Aortic has over 1,250 employees around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition.


Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice.