Food and Drug Administration Status of Endoscopic Anti Reflux Procedures

Four endoscopic anti-reflux devices have been cleared or approved for use in the United States:

the Stretta procedure (Curon Medical, Sunnyvale, CA), the EndoCinch device (Bard, Billerica, MA), Plicator (NDO Surgical, Mansfield, MA), and Enteryx (Boston Scientific, MA). Many other plicator and injection endoscopic anti-reflux devices are currently in development and are expected to be marketed over the next few years. Most have been cleared through a 510k mechanism and only Enteryx has been approved through the pre-market approval (PMA) process that involves a public hearing and a data presentation to an independent Food and Drug Administration (FDA) Advisory Panel. None of the devices have been specifically "labeled" for use in patients failing or recurring after antireflux surgery although there are no warnings or precautions against using these devices in this clinical situation that we are aware of.

Herbal Remedies For Acid Reflux

Herbal Remedies For Acid Reflux

Gastroesophageal reflux disease is the medical term for what we know as acid reflux. Acid reflux occurs when the stomach releases its liquid back into the esophagus, causing inflammation and damage to the esophageal lining. The regurgitated acid most often consists of a few compoundsbr acid, bile, and pepsin.

Get My Free Ebook

Post a comment