Terumo: Aortic Announces US FDA Approval for Thoraflex Hybrid Device


– April 20, 2022 – Terumo Aortic today announced that the United States Food and Drug Administration (FDA) has granted approval for the Thoraflex Hybrid Frozen Elephant Trunk (FET) device for commercial sale in the United States for the treatment of patients with complex aortic arch disease.

Thoraflex Hybrid is the first device of its kind used in frozen elephant trunk (FET) repair in the United States and received Breakthrough Device designation from the FDA in 2021.

Thoraflex Hybrid is a single-use medical device combining a Gelweave polyester graft with a self-expanding Nitinol stent and is indicated for open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta with or without involvement of the ascending aorta in case of aneurysm and/or dissection.

Joseph Coselli, MD (Professor, Executive Vice President, Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, TX, USA), the Principal Investigator, said, “This approval represents an important milestone in treating patients who need total aortic arch replacement and have significant disease of the descending thoracic aorta. They can now be treated at any time in one step with this hybrid device rather than two procedures, which was the conventional route in the United States for this group of patients. This, in turn, reduced the risk of major adverse events by 22.6% in the first year compared to traditional treatments.”

Dr. Coselli continued, “Thoraflex Hybrid facilitates secondary procedures for distal extension and, in the United States, is designed for use with Terumo Aortic’s RelayPro NBS device. This unique labeling aspect provides surgeons with additional confidence if patients have continued progression of aortic disease.

Paul Kuznik, President of Terumo Aortic North America, added, “The FDA approval of Thoraflex Hybrid is a tremendous opportunity for Terumo Aortic in the United States. This innovative hybrid device complements our portfolio of open and endovascular surgical grafts, making us one of the strongest medical providers. device manufacturers in the aortic space, helping us deliver on our commitment to provide solutions for every aorta. »

Thoraflex Hybrid received CE Mark approval in 2012 with over 13,000 devices sold worldwide over the past 10 years. This device is an integral part of Terumo Aortic’s market leading portfolio of surgical, endovascular and hybrid devices to treat every segment of the aorta.

About Terumo Aortic

At Terumo Aortic, we collaborate with our customers to revolutionize aortic care. We offer innovation, versatility and precision with the widest range of solutions that can be
personalized for each patient. We are further complementing our portfolio of implantable devices with 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 worldwide with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.


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