Thursday, December 12, 2019
Breaking Medical Device Industry News

CryoLife Receives CE Mark for E-nya Thoracic Stent Graft

Thursday, December 12, 2019

CryoLife, Inc. announced today it has received CE Mark 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 will be manufactured at the Company’s facility in Hechingen, Germany.

“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.  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,” said Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife.  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.”

Aortic aneurysms and dissections make up the largest portion of thoracic aortic disease which is an estimated $600 million global market.  The vast majority of patients with thoracic aortic disease are treated with minimally invasive endovascular stent-grafts.

E-nya builds upon JOTEC’s experience in the thoracic endovascular aortic repair (TEVAR) market and increases the number of options to treat a broader range of patients.  The system offers both bare spring and covered proximal configurations with tip capture technology, enhancing the control and predictability during deployment while achieving optimal outcomes.  The lower profile graft material leverages JOTEC’s expertise in textile manufacturing and is designed for both flexibility in conformance and long-term durability.

“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,” said Prof. Alexander Oberhuber, Chief of Vascular Surgery, University Hospital of Münster, Germany.

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