Medical device maker Cook Medical won FDA clearance for its Evolution biliary stent, the latest in the company’s line of controlled-release stents designed for use in the gastrointestinal tract.
Like the rest of the Evolution line, the newly cleared biliary stent delivery system includes recapture technology that allows physicians to modify the stent’s placement before full deployment.
"We are thrilled with this addition to the Evolution family," Cook Medical endoscopy division global leader Barry Slowey said in prepared remarks. "Now clinicians can experience the same precision and control throughout the entire GI tract, from the esophagus to the colon."
The Evolution biliary stent has been cleared for the European market since spring of 2012, and more than 1,200 stents have been placed in patients since then, according to a press release. The company expects to launched the stent across the U.S. next month.
Cook Medical suffered some setbacks in its stent line last month when it recalled the Zilver PTX drug-eluting stent after receiving reports of 1 patient death and 1 injury that may have been linked to a fracture in the catheter delivery system. It’s not clear when the devices will be back on the market, a company spokesman told MassDevice.com at the time.