CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for its E-nya thoracic stent graft system for minimally invasive procedures intended to repair lesions of the descending thoracic aorta, including thoracic aortic aneurysms and dissections.
In December 2017, CryoLife completed the $225 million acquisition of German stent graft and surgical graft maker Jotec. Kennesaw, Ga.-based CryoLife’s E-nya system is designed to build upon Jotec’s experience in the thoracic endovascular aortic repair (TEVAR) market and increase options for a wider range of patients.
The system uses bare spring and covered proximal configurations with tip capture technology, meant to improve control and predictability during deployment.
The E-nya system is slated to be manufactured at CryoLife’s Hechingen, Germany, facility. The company expects to launch the product in Europe in the first quarter of fiscal 2020.
“We are pleased to have received CE Mark for the E-nya thoracic stent graft system, our next generation low profile solution for patients with aortic disease,” CryoLife chairman, president & CEO Pat Mackin said in a news release. “The E-nya system was designed to give physicians more options and control while treating both simple and challenging anatomies, and will be one of the most versatile grafts on the market. We are excited to bring this product to the European market, further enhancing our position as the leader in the growing EU aortic repair market.”
“E-nya is the next generation stent graft from Jotec/CryoLife to treat thoracic aortic pathologies,” added University Hospital of Münster (Germany) chief of vascular surgery Dr. Alexander Oberhuber. “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.”
