Scitech’s Solaris Vascular Endograft Evaluated in Postmarket Study

September 15, 2021—Scitech Medical announced that the company has initiated a postmarket clinical follow-up study of its Solaris vascular endograft in Europe. The study will be under the leadership of Michel Bosiers, MD, and coordinated by the Foundation for Cardiovascular Research and Education.

The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the Solaris vascular stent graft. The study will enroll 70 patients with iliac occlusive disease at sites in Germany, the Netherlands, and Italy. Enrollment began in May 2021, and final results are expected in May 2023.

According to the company, Solaris is a flexible self-expanding endograft composed of a thin, multidirectional, durable, electrospinning polytetrafluoroethylene membrane encapsulating a nitinol stent structure. The device has been engineered to cover and instantaneously seal off diseased tissue with a higher multidirectional resistance force, providing an endoluminal bypass option for physicians faced with complex lesions. The device’s design provides high flexibility without compromising the requirement length, balanced radial force, and low shortening rate. Solaris features a pull-back hydrophilic delivery system for navigability and an antijumping system for accurate deployment during the procedure, stated the company.

Scitech Medical announced in October 2019 that the Solaris self-expanding vascular endograft received European CE Mark approval for treating complex peripheral vascular disease.