Baylor College of Medicine

Aortic repair device earns FDA Breakthrough Device Designation

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Joseph S. Coselli, M.D., Surgery

The Thoraflex Hybrid stented device for aortic arch repair by Terumo Aortic has earned Breakthrough Device Designation from the Food and Drug Administration (FDA). Dr. Joseph Coselli, professor, vice-chair, and chief of the Division of Cardiothoracic Surgery at Baylor College of Medicine, is the Principle Investigator for this device.  The aim of Breakthough Device Designation Program of the FDA 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 that consists of gelatin-sealed woven polyester graft and a Nitinol self-expanding stent graft. It is used to surgically repair or replace damaged or diseased vessels of the aortic arch and descending aorta, occurring from a thoracic aortic aneurysm or an aortic dissection (both of which have high mortality rates). “This 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. " said Dr. Coselli. 

Dr. Coselli also serves as chief of adult cardiac surgery at Texas Heart Institute and holds the Cullen Foundation Endowed Chair at Baylor College of Medicine. He specializes in the clinical evaluation and surgical treatment of diseases of the aorta, including the aortic valve and root, ascending aorta, aortic arch, descending thoracic aorta, and thoracoabdominal aorta. Dr. Coselli is an innovator and a leader in his field, and he is highly experienced in complex aortic repair, such as repair performed in patients with connective tissue disorders (such as Marfan and Loeys-Dietz syndromes), as well as emergent repair performed in patients with conditions such as acute aortic dissection or aortic rupture.

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