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Boston Scientific Receives FDA Approval for VICI VENOUS STENT System

Posted on May 06, 2019 by Medtech[y] Staff

The FDA has approved Boston Scientific's VICI VENOUS STENT System for the treatment of iliofemoral venous obstructive disease. The stent system received CE Mark in 2013 and came over to Boston Scientific in their acquisition of VENITI.

The approval of the VICI stent was based on data from the VIRTUS study, which is a prospective, multi-center, single-arm study with 170 patients and evaluated the VICI stent in relation to pre-defined objective performance goals in patients with a clinically significant obstruction in the illiofemoral venous outflow tract. It successfully met its primary safety and effectiveness endpoints.

"For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimized for the disease," said Dr. Mahmood Razavi, St. Joseph Hospital, 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 anatomical tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients."

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