Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its innovative Thoraflex Hybrid stented device for complex aortic arch repair.
The purpose of the FDA's Breakthrough Device Designation program is to fast-track the regulatory review process for certain medical technologies and device-led combination products that satisfy certain criteria; these include providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The aim of the program is to provide patients and healthcare professionals with timely access to important breakthrough medical devices by accelerating their development, assessment and review, while preserving the statutory standards for premarket approval and 510(k) clearance.
Thoraflex Hybrid is a single use medical device combining a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft and is indicated for the surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta.
Advanced age, smoking or genetic inheritance may result in the aortic wall weakening and bulging which can lead to a ruptured thoracic aortic aneurysm (TAA). TAA rupture remains a significantly fatal condition with most patients only surviving for 6 hours if there is no surgical intervention. Another condition is aortic dissection where a tear develops in the vessel wall; should either occur the artery may rupture and only 1 in 5 patients survives.
Joseph Coselli, MD (Professor, Vice Chair and Chief, Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, Texas, US) the principal investigator for Thoraflex Hybrid commented: "This breakthrough designation from the FDA will allow US physicians to treat patients who may be at great risk of rupture with a device that brings the primary benefit of requiring a single stage procedure instead of the conventional treatment involving two procedures thus lowering the risk of patient mortality and potentially reducing overall operating time and hospital costs."
John Canning, Chief Technical Officer with Terumo Aortic added: "The announcement from the FDA is very encouraging and we look forward to close collaboration with the FDA to advance treatment options for patients suffering from this deadly disease."
Thoraflex Hybrid is the latest innovation within Terumo Aortic's market-leading portfolio of surgical, endovascular and hybrid devices to treat every segment of the aorta. Thoraflex Hybrid became the world's first multi-branched "frozen elephant trunk" prosthesis when it received CE Mark approval in 2012.
About Terumo Aortic
At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable surgeons to find the right fit for each patient anatomy.
Notes to Editors
Terumo Corporation of Japan, a global medical device company founded in 1921 currently has over 25,000 employees worldwide.
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.
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 28,000 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.