A Nissen fundoplication is surgical reinforcement of the lower esophageal sphincter accomplished by wrapping the top of the stomach around the bottom of the esophagus and stitching it into place. Several companies have manufactured endoscopic devices that can sew or staple and effectively provide a similar effect as a Nissen procedure. Currently, three endoscopic stitching or sewing devices are approved by the FDA and are on the market. Each device is different and requires a different technique to deliver a suture or stitch, but the results are roughly the same.
The Bard EndoCinch has been on the market since 2000 and is the most studied and tested of the devices mentioned here. A complicated technique of placing several stitches in the region of the esophagogastric junction is required. Studies on patient outcome are limited. In a 2-year study of 85 patients who had the procedure, more than half of the patients reported improved acid reflux symptoms and more than 40% did not require PPI medication at 2 years.
Another sewing device is the NDO Surgical Plicator. The plicator is another nonsurgical, endoscopyassisted technique to tighten the LES. This device is FDA approved and is currently available. Studies of patient outcome at 1 year suggest similar results as those obtained with the Bard EndoCinch in terms of acid control and need for medication.
The third device is the Wilson-Cook Endoscopic Suturing Device. It is used in an endoscopy-assisted and nonsurgical procedure to tighten the LES. This device is FDA approved and is commercially available; however, there is very little human data regarding outcome.
It is interesting to note that the FDA regulates all prescribed drugs and surgical devices in the United States. For a new drug to become FDA approved, hundreds of millions of dollars are spent by a drug company. The drug is tested for years for safety, efficacy (meaning it works for the illness it was made for), and appropriate dosing. Then, the drug is approved and followed to see whether any new side effects or bad reactions are reported when it is marketed to the public and thousands or millions of people take it. At any point in the process, the FDA can step in and stop or remove a drug from the market. Several drugs underwent years of testing only to be removed from sales in the United States. Some of the most notable are thalidomide, which caused birth defects; dexfenfluramine (Redux) for weight loss, which may have caused heart problems; and rofecoxib (Vioxx), an arthritis drug which may increase risk of heart attacks.
This, however, does not apply to surgical devices, which are approved by the FDA after little testing. Really, only when the device is out on the market and being used are side effects and complications found. This is the case for endoscopic or noninvasive antireflux procedures. These technologies are FDA approved only after they are documented to work and are shown to be safe for a small number of test subjects. The demonstration of safety and long-term benefit comes after they are out and used on thousands of people. It was this postmarketing safety information that led the FDA to remove Enteryx from the market.
By Mortin - Copyright 2009
Last modification 31/12/2009
What is an EndoCinch? References