Terumo Aortic announced in a press release 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, multicentre, non-randomised, single arm, all-comer, postmarket study of Thoraflex Hybrid and RelayPro non-bare stent (NBS).
The aim of the EXTEND study is twofold, the company states: 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.
This global study will include up to 55 centres 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, cardiac surgeon at MedStar Washington Hospital Center (Washington DC, USA) enrolled the first subject.
European principal investigator Martin Czerny, consultant cardiovascular surgeon, University Hospital Freiburg, (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, vice chief, Division of Cardiovascular Surgery, University of Pennsylvania (Philadelphia, USA), 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 [US] FDA-approved hybrid graft in the USA for frozen elephant trunk procedures and RelayPro NBS is the only endovascular graft [US] 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 revolutionise future treatment options for patients. Terumo Aortic is committed to building clinical evidence that supports the entire aortic solutions portfolio.”