May 7, 2019

FDA approves new Boston Scientific pelvic stent

Photo | TMS Aerial Solutions
Boston Scientific's Marlborough headquarters

Boston Scientific has received U.S. regulatory approval for a new stent to treat blood clots in the pelvic region.

The device, the Vici Venous Stent, treats iliofemoral venous obstructive disease, which occurs when the flow of blood through the veins deep in the pelvic region becomes blocked by a blood clot or other anomalies.

The U.S. Food and Drug Administration approved the device Monday.

The Marlborough medical device makers said the approval of the stent was based on data from a 170-patient study finding the device met its primary safety and effectiveness goals.

The system, developed by California-based VENITI, Inc., received the CE Mark for European clearance in 2013 before Boston Scientific acquired the company in 2018 for $108 million in cash.

The system's approval now brings VENITI another $52 million in contingency payments upon the device's U.S. approval.

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