Kawasumi’s Najuta Thoracic Stent Graft Receives CE Mark Approval for TEVAR
October 17, 2017—Kawasumi Laboratories, Inc. announced European CE Mark approval in July for the Najuta thoracic stent graft system, which is indicated for thoracic endovascular aneurysm repair (TEVAR) in patients with thoracic aortic aneurysms. The company is planning to launch Najuta in Italy at the end of this year. The device has also received regulatory approval in Japan.
According to the company, each Najuta device is a semicustom-made stent graft that is preshaped for conformability in tortuous aortic anatomy. The device is individually designed using three-dimensional CT imaging. There are single or multiple fenestrations along its greater curvature to secure blood supply via the arch vessels.
The Najuta device demonstrated good long-term results in the 5-year, nonrandomized, multicenter KSG-001 clinical trial that was conducted in Japan to evaluate the safety and effectiveness of the device, noted Kawasumi.
Prof. Franco Grego, MD, commented in the company's announcement, “The Najuta is an attractive new TEVAR device option because its fenestration design and semicustomization allows physicians to consider this less invasive procedure for many patients, especially those with short neck who might otherwise be ineligible for TEVAR.” Prof. Grego is with the University Hospital of Padua in Padua, Italy.