Bloomington-based Cook Medical is taking one step forward and one step back with its stent businesses this spring.
Last week, Cook won approval from the U.S. Food and Drug Administration for a new kind of stent to prop open patients' bile ducts. That used to be no big deal, but in recent years, it’s been tougher and tougher to get the OK from the FDA.
The decision gives Cook a new product to offer to the 35,500 Americans each year that receive such a stent, which is designed to relieve symptoms of an obstructed bile duct, according to Today’s Medical Developments, a trade publication.
Cook won approval for its biliary stent in Europe a year ago and has since sold 1,200 of them, according to the trade publication. It sells similar stents, which can be retrieved and replaced by physicians during surgery, for use in the colon, esophagus and duodenum.
“Now clinicians can experience the same precision and control throughout the entire GI tract, from the esophagus to the colon,” said Barry Slowey, global leader of Cook Medical’s Endoscopy division, in a prepared statement.
But in a separate move in late May, the FDA slapped its “deadly” warning on Cook’s recall of its Zilver PTX stent, which props open arteries in the legs and arms to prevent serious blood clots.
That recall, which was initiated by Cook before public action by the FDA, is potentially costly to Cook. Millenium Research Group has estimated that Cook derives $2,750 from each Zilver stent it sells in the United States.
Cook spokesman David McCarty declined to say how many Zilver stents the company has recalled. Since it first hit foreign markets in 2009, the Zilver stent has been deployed in more than 30,000 patients, according to data from Cook.
Millennium estimated that in the United States alone, sales of the Zilver could hit 40,000 per year, generating $110 million in annual revenue. The Zilver, which is the first stent covered with an inflammation-reducing drug, has been selling in Europe and other foreign markets since 2009. Cook introduced it to the U.S. market in December 2012.
The Zilver recall did not affect stents that were already placed in patients because a small number of them broke off from the catheter delivering them into the patients during surgery. But the problem could cause thrombosis and even death, according to the FDA.
McCarty said all the Zilver stents sold from Dec. 13 to April 16 have now been called in from the field and new stents have been manufactured at Cook's plant in Limerick, Ireland. Cook is waiting for regulatory approval to send out the replacement Zilver stents.
“We're preparing to return to market as quickly as possible,” he wrote in an email. “Lots of patients out there needing this device and lots of doctors asking when it will be back.”