CryoLife has received two CE marks, with one for the E-nside thoracoabdominal aortic aneurysm stent graft and one for the E-nya thoracic stent graft system. Two press releases announcing the CE marks, respectively, report that E-nside is the company’s newest proprietary endovascular stent graft for patients with thoracoabdominal aortic disease and that the E-nya thoracic stent graft system is for the minimally invasive repair of lesions of the descending thoracic aorta (including thoracic aortic aneurysms and dissection).
According to the E-nisde press release, the system’s pre-cannulated inner branches are designed to reduce the overall procedure time and patient exposure to radiation. Furthermore, the E-nside multibranch stent graft system was designed based on Jotec’s (part of Cryolife since 2017) extensive experience over the last seven years with more than 2,000 implants in the thoracoabdominal space. The CE mark for E-nside, the press release states, positions CryoLife well in the EU aortic stent graft market due to Jotec’s E-xtra Design Engineering programme. The programme seeks to provide patient-specific solutions, as well as due to the synergies between E-nside and Jotec’s existing portfolio of thoracic and abdominal stent grafts.
Pat Mackin, chairman, president, and CEO of CryoLife, comments: “We are pleased to have received CE Mark for E-nside, the only off-the-shelf pre-cannulated thoracoabdominal stent graft with inner branches. This device will help us more rapidly serve physicians by eliminating the waiting period experienced by approximately 70% of patients who would normally require a custom-made stent graft. The device will also benefit some patients by eliminating their need for an open surgical procedure.”
The E-nya press release says that the graft 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. It adds that 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.
Regarding the CE mark for E-nya, Mackin says: “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. 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.”