Cook Medical landed 510(k) clearance from the FDA for its Evolution duodenal controlled-release stent for the treatment of malignant gastric outlet obstruction.
Meant for use in patients with pancreatic or GI-related cancers, the stent offers relief of abdominal pain, vomiting, malnutrition and aspiration associated with obstructions in the intestinal tract.
"The Evolution duodenal stent provides physicians with highly accurate stent placement, reducing the risk of migration, perforation and minimizing the need for repeat procedures," said Barry Slowey of Cook Medical’s Endoscopy division in prepared remarks.
The esophageal version of Cook’s Evolution line won clearance from the federal watchdog agency last year.
It’s the second FDA-related win for Cook in as many weeks. Its Zilver PTX stent got a unanimous OK from the FDA’s Circulatory Systems Devices Panel last week, putting it on track for U.S. market clearance in the next few months.
The Zilver device is a self-expanding drug-eluting stent coated in paclitaxel and used in treatment of peripheral artery disease. If approved, it will be the first of its kind for the treatment of femoropopliteal arteries.
Cook filed its PMA application for the Zilver stent in June 2010, and has had CE Mark approval for sales in Europe since 2009.