In November 2014, Jotec received CE mark approval for the new E-tegra AAA Stent Graft System. The stent graft system is indicated for endovascular treatment of infrarenal abdominal aortic aneurysms and, according to the company, incorporates numerous innovative technical solutions with respect to implant and delivery system.
The stent graft is equipped with a unique asymmetric spring configuration to achieve exceptional 3D flexibility while maintaining appropriate longitudinal stiffness. The asymmetric stent shape, together with a completely new and seamless polyester cover, supports higher flexibility, thus guaranteeing superior conformability and vessel adaption even in complex anatomies, according to Jotec. The stent graft has active fixation at the proximal laser-cut stent which can be released separately ensuring precise positioning. Effective sealing is achieved through a special proximal sealing stent. Various stent graft configurations round off the picture and allow best possible treatment of the patient, the company said.
The E-tegra delivery system has a low crossing profile of 18F (OD) and offers excellent pushability and enhanced flexibility without risk of kinking. The hydrophilic coating of the catheter facilitates introduction and advancement even in narrow and tortuous vessels. The E-tegra delivery system features the Squeeze-to-Release deployment mechanism for precise positioning and safe handling.
In order to provide physicians with clinical data about safety and efficacy when using the new E-tegra Stent Graft System, Jotec has set up an International Post Market Registry. The principal investigator will be Sven Seifert from Hospital Chemnitz, Germany.
The E-tegra Stent Graft System is available and will be stepwise introduced to the European market.