FDA Clears Two Gastrointestinal Stents

Food and Drug Administration (FDA).

The Unistep Plus Wallstent Enteral Endoprosthesis was cleared for the relief of malignant obstructions of the colon and duodenum as well as a bridge to surgery, an alternative to temporary surgical colostomy. This stent opens passageways, relieving painful symptoms of obstruction, and improves the quality of life for patients unable to undergo a surgical procedure. No incision is needed for stent placement, and the procedure allows additional time for physicians and patients to plan the best method of treating the underlying malignancy. In addition to avoiding the trauma and risk of a temporary colostomy, patients avoid the lengthy follow-up required to heal a stoma once the colostomy is removed.

The Unistep Plus Permalume Covered Biliary Wallstent was cleared for palliating malignant obstructions of the bile duct. It is a covered metal biliary stent, designed to reduce tissue in-growth that leads to the incidence of premature stent occlusion. This could minimize complications and reduce the likelihood of additional interventions.

Both stents are from the gastrointestinal endoscopy division of Boston Scientific/Microvasive (Natick, MA, USA). "Our work with leading experts in the field has enabled us to develop these less-invasive alternatives for gastrointestinal diseases that will greatly improve patient care and dramatically reduce costs,” said Greg Barrett, president, Boston Scientific/Microvasive.



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