Medical device company Medtronic has launched a study into safety and effectiveness of its Abre venous self-expanding stent system.
Stent
The investigation device exemption (IDE) study will evaluate the use of the device in subjects with iliofemoral venous outflow obstruction.
The study intends to enrol 200 subjects with deep venous disease from across 35 sites throughout the US and Europe.
Data from the study will be used to support the device’s pre-market approval (PMA) application.
Medtronic estimates that more than 24 million people are affected by deep venous obstruction worldwide. The condition occurs when veins in the deep venous system become compressed and restrict blood flow.
The Abre device is intended to be permanently implanted in the iliofemoral vein, exerting an outward force to open the vein.
The first procedure using the device was performed in December 2017 by Dr Erin Murphy, director of the venous and lymphatic program at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, North Carolina, and national principal investigator for the Abre IDE Study in the US.
The primary efficacy endpoint will evaluate patency at 12 months, which is defined by freedom from occlusion and freedom from clinically-driven target lesion revascularization (CD-TLR).
The primary safety endpoint will evaluate the incidence of composite Major Adverse Events (MAE) at 30 days following stenting of an obstruction in the iliofemoral venous segment.
Speaking about the study, Dr Murpy said: “The launch of the Abre IDE Study marks the beginning of an important journey to establish new options for the treatment of deep venous disease."
Sandra Lesenfants, vice president and general manager of the endoVenous business, said: “With the growth of our superficial venous product portfolio, we have established ourselves as leaders in this space. Now, with our entry into the deep venous space, we are well positioned to offer a comprehensive portfolio for the treatment of venous disease.
"While our entrance into the deep venous space is recent, we believe the Abre IDE Study and our regulatory approval in Europe positions us well for future growth in this area. We look forward to continuing to enrol patients in the IDE study and working with the clinical community to address critical needs of patients with deep venous disease."