May 6, 2019
Boston Scientific's Vici Venous Stent Gains FDA Approval
May 6, 2019—Boston Scientific Corporation has announced receipt of FDA approval for its Vici Venous stent for the treatment of iliofemoral venous obstructive disease. The approval is based on data from the prospective multicenter VIRTUS study, which met its primary safety and effectiveness endpoints.
The single-arm study evaluated Vici in 170 patients with clinically significant obstruction in the iliofemoral venous outflow tract, using predefined objective performance goals as a benchmark, the company noted. The 12-month data from VIRTUS were presented by Principal Investigator Mahmood K. Razavi, MD, at the Leipzig Interventional Course (LINC) in January 2019. For more on the VIRTUS data, please see our LINC coverage.
"For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimized for the disease," said Dr. Razavi, in the company's approval announcement. Dr. Razavi is from St. Joseph Hospital in Orange, California. "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 anatomic tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients."
Vici becomes the second venous stent approved by the FDA, joining BD's Venovo device, which gained approval in March 2019.