A New Device Receives FDA Approval for Treating Gastrointestinal Bleeding

The US Food and Drug Administration (FDA), for treating gastrointestinal (stomach and bowel) bleeding, approved Hemospray , a new medical device, on 7 May 2018.

The device offers certain patients with upper or lower gastrointestinal bleeding a nonsurgical option to reduce the risk of death from stomach bleeding for many patients.

What Is Gastrointestinal Bleeding?

The gastrointestinal tract has two parts: the upper tract includes the esophagus, stomach or small intestine, and the lower tract includes the colon and rectum. Bleeding in these areas is called gastrointestinal (GI) bleeding and, if it occurs in the esophagus, stomach or small intestine, upper GI bleeding; in the colon and rectum, it is lower GI bleeding as classified.

Possible Causes of Gastrointestinal Bleeding Include:

• Gastric (stomach) ulcers,
• Structural blood vessel changes (arteriovenous malformations),
• Diverticula,
• Cancer (such as stomach or colon cancer), or
• Inflammatory bowel disease.

Severe gastrointestinal bleeding carries a high mortality risk, particularly in older patients.

Hemospray is designed to treat most types of upper or lower gastrointestinal bleeding. The device is an aerosol spray delivering a mineral mixture to the bleeding site. It is used during an endoscopic procedure and can be applied over large areas such as a large ulcer or tumor.

It was not developed for patients with esophageal variceal bleeding arising in conditions such as alcohol-related liver disease.

The studies supporting FDA approval examined data from a total of 750 patients with upper or lower gastrointestinal bleeding. Hemospray stopped gastrointestinal bleeding in %95 of patients five minutes after use. Of these patients, % 20 experienced rebleeding, mostly within 72 hours, and use could extend to 30 days. Approximately %1 experienced intestinal perforation as a serious adverse effect. Hemospray is unsuitable for patients with gastrointestinal fistulas or high gastrointestinal perforation risk.

The device's design can be seen below: