|Cook Medical's Evolution esophageal stent--Courtesy of Cook Medical|
In a potential first, Cook Medical wants to see whether a self-expanding metal esophageal stent can be regularly removed when its job is done. In the U.S., at least, that practice doesn't usually happen, as esophageal stents are placed permanently to treat conditions relating to esophageal cancer and other related blockages and diseases.
"We are very excited to see where this study takes us," Barry Slowey, global leader of Cook's Medical Endoscopy division, said in a statement.
The North Carolina device company is planning a multicenter U.S. study to explore whether its new Evolution esophageal fully covered stent can be successfully taken out after treatment. Plans call for enrolling up to 130 patients in the study at up to 15 U.S. sites. They'll be tracked for as long as 6 months after stent placement, and then 30 more days after surgeons take the device out.
Cook bills the study as the first multicenter trial of its kind to explore whether a self-expanding metal stent can be removed, and the company tweaked its Evolution stent for the study to make this process more feasible. They'll look for a wide variety of patients who need a stent to relieve an obstruction caused by malignant or benign growths. Folks with esophageal fistulas, perforations or leaks, among other challenges, may also be eligible if they meet all the criteria.
Stents have revolutionized areas such as cardiac care worldwide, but they also are seen by some as leading to increased risks of health problems such as strokes. Their presence helps to reduce the risk of future blockages--but they have also potentially contributed, in some cases, to that risk. Stents used in other parts of the body also draw concerns about health risks because of their permanence.
Dr. John Vargo, chairman of Gastroenterology and Hepatology at the Cleveland Clinic, will lead the prospective, single-arm study. He noted in a statement that "defining the role of removable stents in benign and malignant esophageal disorders is still a quandary for clinicians," but that the study is intended to figure out a way.
It's been a generally positive fall for Cook after a rougher time earlier this year. In October, the company touted stellar four-year patient data for its signature Zilver PTX drug-eluting stent. But that was 6 months after launching a global recall because some of the devices broke from their delivery catheters during implantation.
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