CryoLife’s Thoraco-abdominal Stent Graft Gains CE Mark

CryoLife Inc., a cardiac and vascular surgery company focused on aortic disease, has received CE mark for the E-nside TAAA multibranch stent graft system for the endovascular treatment of thoraco-abdominal aneurysms. 
 
Approximately 20,000 patients with thoraco-abdominal disease are treated annually worldwide, which places the overall market at approximately $215 million. The vast majority of these patients are treated with risky, invasive open surgical procedures, characterized by lengthy hospitalization periods and prolonged recuperation, or with custom-made stent grafts which can take up to 90 days to manufacture. E-nside is the Company’s newest proprietary endovascular stent graft for patients suffering from thoraco-abdominal aortic disease. The product’s pre-cannulated inner branches are designed to reduce the overall procedure time and patient exposure to radiation.
 
“We are pleased to have received CE mark for E-nside, the only off-the-shelf pre-cannulated thoraco-abdominal stent graft with inner branches. This device will help us more rapidly serve physicians by eliminating the waiting period experienced by approximately 70 percent 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,” remarked Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife.
 
The E-nside TAAA multibranch stent graft system was designed based on JOTEC’s extensive experience over the last seven years with more than 2,000 implants in the thoraco-abdominal space. Thoraco-abdominal disease frequently extends into both the thoracic and abdominal aorta which often requires more than one device type to repair the condition. The CE mark for E-nside positions CryoLife well in the EU aortic stent graft market due to JOTEC’s E-xtra Design Engineering program which provides patient-specific solutions, as well as due to the synergies between E-nside and JOTEC’s existing portfolio of thoracic and abdominal stent grafts. The E-nside stent graft system will be manufactured at the Company’s facility in Hechingen, Germany.
 
Dr. Achmed Koshty, Diakonie Klinikum Jung-Stillen in Siegen, Germany commented, “E-nside, a new off-the-shelf multi branch endovascular stent graft system, addresses a significant unmet need in the endovascular treatment of the aorta. A life-saving device, E-nside provides a fast and secure option in the treatment of thoraco-abdominal aneurysms. With the addition of E-nside, JOTEC now offers a complete portfolio of the devices to treat aortic lesions from the aortic valve to the iliac arteries.”