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.