Jotec Commences PLIANT Postmarket Registry

August 7, 2014—Jotec GmbH announced the initiation of the PLIANT postmarket registry of the company’s new-generation, low-profile E-liac stent graft system in patients with iliac aneurysm undergoing endovascular stent treatment. In January, Jotec announced that the E-liac system received European CE Mark approval for the endovascular treatment of aortoiliac aneurysms or isolated iliac aneurysms.

According to the company, the objectives of the multicenter study are to evaluate clinical and technical success as well as the safety and feasibility of the E-liac stent graft system used in endovascular treatment of unilateral or bilateral aortoiliac or isolated common iliac aneurysm. The main target of the study is the exclusion of aneurysm with primary patency of the internal iliac artery and external iliac artery on the iliac implantation side.

Jotec advised that 40 patients, including both men and women, will be included and treated with the E-liac stent graft in the course of the study. The period of data collection for each patient will be 36 months from the intervention. More than 11 European clinical centers specializing in the endovascular treatment of iliac aortic aneurysms will participate in this cohort study. The study was started in May 2014 with the primary ethical vote and is planned to be completed in 2018. PLIANT’s principal investigator is Prof. Jan Brunkwall, MD, from the University Hospital Cologne in Germany.

As detailed by the company, the Jotec E-liac stent graft is a new generation of a side branch device that incorporates numerous technical innovations to treat a broad range of anatomies. The stent graft features an asymmetric spring configuration to achieve high 3D flexibility while maintaining appropriate longitudinal stiffness. Also, the device includes a freestanding side branch with distal compression stent and excellent x-ray visibility. Various stent graft configurations are available for individual treatment of the patient. The low-profile 18-F delivery system is adapted for crossover maneuvers and is equipped with a newly designed end cap with several functionalities.