December 2, 2019
CryoLife Receives CE Mark for E-nya Thoracic Stent Graft
December 2, 2019—CryoLife, Inc. announced it has received European CE Mark approval for the E-nya thoracic stent graft system for the minimally invasive repair of lesions of the descending thoracic aorta, including thoracic aortic aneurysms and dissections.
The E-nya thoracic stent graft was developed by Jotec GmbH, a German-based developer of technologically differentiated endovascular stent grafts and cardiac and vascular surgical grafts, focused on aortic repair. CryoLife, based in Atlanta, Georgia, acquired Jotec in 2017. The E-nya device will be manufactured at the company’s facility in Hechingen, Germany.
According to CryoLife, the E-nya device builds on Jotec’s experience in the thoracic endovascular aortic repair market and increases the options to treat a broader range of patients. The system offers both bare spring and covered proximal configurations with tip capture technology, enhancing control and predictability during deployment while achieving optimal outcomes. The lower profile graft material is designed for flexibility in conformance and long-term durability.
Professor Alexander Oberhuber, MD, commented in the company’s announcement, “E-nya is the next-generation stent graft from Jotec/CryoLife to treat thoracic aortic pathologies. The combination of the new delivery system with the completely redesigned stent graft improves flexibility, allowing surgeons to treat a broader range of patients and more complex pathologies.” Prof. Oberhuber is Chief of Vascular Surgery at University Hospital of Münster in Germany.