Benefits of Polyflex Esophageal Stents For Treating Refractory Benign Esophageal Strictures
By Boston Scientific
May 25, 2006, 12:59

Boston Scientific Corporation today announced the results of two studies on the use of its Polyflex® Esophageal Stent, a fully covered, self-expanding, silicone-coated temporary stent designed for use in patients with refractory benign or malignant esophageal strictures. The results of these studies were presented at the Digestive Disease Week® (DDW®) meeting in Los Angeles.

Benign gastroesophageal anastomotic strictures (AS) are a post-surgical complication that occur in up to 43 percent of patients who undergo transhiatal esophagectomy (THE), the removal of the esophagus through the diaphragm without opening the chest. These strictures are a narrowing of the esophageal passageway which may be caused by scar tissue or inflammation. Management of AS may require extensive periods of serial endoscopic dilation typically performed with a balloon. Repeated dilation poses significant risk, cost and patient inconvenience.

A study led by James Barthel, M.D., of the University of South Florida College of Medicine, examined the placement of the Polyflex Stent to determine whether its use could reduce the number of endoscopic interventions required by patients to manage persistent AS. This five-patient study found that the Polyflex Stent reduced the number of endoscopic interventions and allowed patients to extend the average time without repeated dilation from 6.8 to 76 days.

“The results of the study illustrate the potential benefits of using the Polyflex Esophageal Stent to reduce the number of endoscopic interventions in patients with resistant benign gastroesophageal anastomotic strictures,” said Dr. Barthel. “Having to undergo serial dilations is problematic for patients and this study should help raise awareness among physicians that the use of the Polyflex temporary stent may provide a favorable alternative for some patients.”

A second Polyflex Stent study, reported at DDW by Kulwinder S. Dua, M.D., and Rajesh Santharam, M.D., of the Medical College of Wisconsin, investigated the effectiveness of using the Polyflex Stent to reduce the number of dilations to relieve dysphagia caused by resilient non-peptic benign esophageal strictures.
Dysphagia, difficulty or discomfort when swallowing, is one of the most common symptoms in patients with esophageal strictures. These types of strictures can have a severe impact on a patient’s quality of life and can lead to complications such as aspiration, weight loss and malnutrition. In the most severe refractory cases, patients may even require balloon or rigid dilations as frequently as every few weeks to relieve symptoms.
In the study, researchers determined that the Polyflex® Stent can be deployed and removed in the majority of patients with resilient benign esophageal strictures. Removal after four weeks in place can result in long-term relief of dysphagia in over 40 percent of patients (median follow up 54 weeks) without further re-interventions. Other patients preferred long-term re-stenting rather than going back to their baseline approach of repeated dilations or undergoing surgery. Further large scale prospective studies will be required to determine the optimal duration for keeping the stent in place before removal and to determine if the stricture characteristics and etiology can predict the response rates. As the procedure carries risks, it should be considered in carefully selected patients.
“We are pleased that the results of this study illustrate that patients have another option besides repeated dilation,” said Dr. Dua. “With the Polyflex Stent, many patients experienced long-term relief without having to undergo further dilation or surgery.”

Esophageal stenting is a less-invasive procedure in which a stent is inserted via a delivery system into the esophagus and placed across malignant or refractory benign strictures to maintain the natural opening. The Polyflex Esophageal Stent System is indicated for the treatment of esophageal stenosis, including benign refractory strictures, malignant strictures, esophago-respiratory fistula, and for maintaining esophageal lumenal patency caused by intrinsic or extrinsic tumors.

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