Scitech Medical's Solaris Vascular Endograft Receives CE Mark Approval

October 8, 2019—Scitech Medical announced that the company’s Solaris self-expanding vascular endograft received European CE Mark approval for treating complex peripheral vascular disease.

According to the company, the flexible device is composed of a thin, multidirection, durable, electrospinning, polytetrafluoroethylene membrane encapsulating a nitinol stent structure. The device has been engineered to effectively cover and instantaneously seal off diseased tissue with high multidirectional resistance force, thereby providing an endoluminal bypass option for physicians faced with complex lesions.

The design provides high flexibility without compromising the required length, balanced radial force, and low shortening rate. The pullback hydrophilic delivery system provides superior navigability and the antijumping system guarantees accurate deployment during the procedure, noted Scitech Medical.

In the company’s announcement, Armando Lobato, MD, who is Medical Director of São Paulo Vascular & Endovascular Surgery Institute in São Paulo, Brazil, commented, “The Solaris endograft surprised me by the accuracy of its delivery system, its radiopacity, and radial force. In my clinical practice, the Solaris has shown excellent midterm safety and efficacy profile."