Cook Medical (Bloomington, Indiana) is aiming toward getting its metal removable stent approval in the U.S. The firm took tremendous steps in achieving this goal when it reported that it has initiated a clinical study to evaluate the removability of its new Evolution Esophageal fully covered stent. The stent design used in the study has been modified to accommodate retrieval. The study will also evaluate the use of the device in esophageal conditions, including strictures, fistulas, perforations or leaks.
The company said that the Evolution Esophageal study will be conducted at up to 15 sites across the U.S. and will enroll 130 patients. Patients will be followed for the duration of stent placement up to six months. After endoscopic stent removal, specified patients will have a 30-day follow-up that will complete his or her enrollment.
"The version of the stent that we're doing in the clinical trial is approved in Europe," Angela Wiant, the product manager for the Evolution Esophageal stent, told Medical Device Daily. It is CE marked for removability and so that's what we're working on obtaining with this clinical trial. We estimate study enrollment to be completed by the end of 2014 and then we would expect data follow up and enrollment follow up to be completed by 2015."
She added, "We could see some initial study results at some point next year in 2014 or early 2015."
Evolution could appeal to patients suffering from benign strictures.
"A benign stricture could be a couple of examples," Wiant said. "It could come from post radiation. So maybe the patient had radiation therapy to treat the cancer and it caused a stricture in their esophagus so this stent would be placed to allow the esophagus to open up and then be removed once it is open enough for a patient to swallow their food orally. That's one example. In this clinic trial, we're also looking at using this stent for sealing a leak. So there could be a post surgical leak that needs to be sealed off and healed, and then it can be removed once that healing process is complete.
The study, led by Principal Investigator John Vargo MD, MPH and chairman of Gastroenterology and Hepatology at the Cleveland Clinic, is a prospective, single-arm study. Patients can be enrolled in the study when they require a stent for an obstruction that is caused by an intrinsic or extrinsic malignancy or a refractory benign esophageal stricture. Also, patients that have an esophageal fistula, perforation or leak can be included in the study. There are additional eligibility criteria for the study.
"Defining the role of removable stents in benign and malignant esophageal disorders is still a quandary for clinicians," said Vargo. "This multicenter study which involves many of the leading centers in therapeutic endoscopy, should help answer this question."
The firm said that it has seen strong uptake of the device in Europe.
"We've seen an increase in the need for a stent that can be removed after placement," Wiant said. "Today there is only one stent cleared in the FDA for removability and it is a plastic stent. [Based on its performance in Europe] we have a fully covered metal stent that offers some advantages clinically to patients that need a stent for just a few weeks. The stent can go and do its job and help the patient and be removed once the stricture area has been resolved. It's a big advantage to patients that currently today do not have a really good option for managing a benign stricture. We do see it performing very well in Europe where its being used today."
"We are very excited to see where this study takes us," said Barry Slowey, global leader of Cook Medical's Endoscopy division. "We hope that the results of this study will allow for some expanded treatment options for malignant and benign esophageal diseases."