Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Vici Venous Stent system to treat iliofemoral venous obstructive disease.
Image: Vici Venous Stent system. Photo: courtesy of Boston Scientific Corporation.
Venous obstructive disease is said to occur when the flow of blood through the veins located deep in the pelvic region is blocked by a blood clot or compressed by anatomical anomalies.
The disease, which affects around 40% of the population in the US, can be caused by conditions such as deep vein thrombosis (DVT), post-thrombotic syndrome (PTS) and compressive diseases such as May-Thurner syndrome.
Endovascular treatment for venous obstructive disease will mainly focus on restoring the normal flow of blood from the legs back to the heart.
The iliofemoral veins are situated in the pelvis, and are subjected to major crushing forces from other anatomical structures such as the right common iliac artery.
Vici Venous Stent system has been specifically developed to be uniformly strong and crush resistant, and it can restore blood blow by creating a cylindrical and patent vessel.
California-based St. Joseph Hospital’s Dr Mahmood Razavi said: “With the approval of the VICI stent, clinicians now have access to a stent that was purposely developed and engineered to resist the vessel compression and anatomical tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients.”
Vici system’s approval was based on data from the Virtus study, which is a prospective, multi-center and single-arm trial with 170 patients.
The trial assessed the Vici stent in relation to pre-defined objective performance goals in patients with a clinically significant obstruction in the illiofemoral venous outflow tract. The study successfully achieved its primary safety and effectiveness endpoints, said the company.
The company secured CE mark for Vici stent system in 2013. Veniti, a company acquired by Boston Scientific in 2018, had developed Vici stenet system.
Boston Scientific peripheral interventions president and senior vice president Jeff Mirviss said: “The FDA approval of the VICI venous stent system is the latest example of our commitment to building the most comprehensive portfolio of technologies specifically developed to meet the needs of physicians treating both chronic and acute venous disease