June 7, 2016
Clinical Trial Begins for Medtronic's Next-Generation Valiant Evo TEVAR Device
June 8, 2016—Medtronic plc and the University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas announced the enrollment of the first patient in a clinical study assessing the Valiant Evo thoracic stent graft system for the minimally invasive repair of descending thoracic aortic aneurysms (TAA).
The international, multicenter, prospective study will include 100 patients treated with thoracic endovascular aortic repair (TEVAR) in the United States and Europe. The initiation of enrollment was reported at the 2016 Vascular Annual Meeting of the Society for Vascular Surgery, which is being held June 8–11 in National Harbor, Maryland.
The United States Principal Investigator for VEVO, the Valiant Evo United States clinical trial, is Ali Azizzadeh, MD, who is Professor and Chief of Division of Vascular and Endovascular Surgery in the department of Cardiothoracic and Vascular Surgery at McGovern Medical School at UTHealth.
Dr. Azizzadeh performed the first procedure on a patient with a descending TAA in the investigational device exemption trial. He noted that the patient is an 88-year-old man who is doing well after treatment. In the announcement, Dr. Azizzadeh commented, “The Valiant Evo clinical study has the potential to expand the applicability of TEVAR to a wider spectrum of patients.”
According to Medtronic and UTHealth, the Valiant Evo system is a lower-profile evolution of the company’s Valiant Captivia system. The Valiant Evo system is designed with an 18-F and 20-F outer-diameter profile for most size configurations, proximal closed web and FreeFlo configurations with tip capture, and high stent graft conformability. Additional features include broader tapered offerings and longer lengths for anatomical customization, in addition to an improved ergonomic delivery system.
Medtronic and UTHealth advised that the Valiant Evo is an investigational device and is not yet approved for commercial use in the United States.