Bare-metal colonic stent

A bare-metal colonic stent is a sterile, non-bioabsorbable tubular device designed to be implanted in the colon lumen to relieve obstruction caused by malignant strictures, most commonly in the descending, sigmoid colon, or rectum. It is delivered via a catheter or similar instrument and self-expands upon deployment to restore luminal patency, primarily for palliative care in patients with colorectal cancer who are not surgical candidates or require preoperative decompression.

These devices are regulated as implantable medical devices intended for temporary or palliative use in the gastrointestinal tract. They are supplied sterile for single-use and are classified based on their intended use and risk profile, with regulatory requirements focusing on material biocompatibility, mechanical performance, and sterility assurance as defined in the reference definition.