FDA Approves “PillCam” That You Swallow For Colonoscopy Procedures

It’ been a long wait in the US as the PillCam has been approved for use in other countries for a number of years. You swallow it and the imaging begins. Of course it remains in your body for a while and then it takes the normal way out via the colon.

The PillCam costs $500.00 and is a lot less expensive than a regular colonoscopy. Initially the pill is slated for use with patients than could not tolerate a normal colonoscopy. It is battery operated and another device captures the images taken.

You can read more at the Given Imaging web site. The company also has other PillCams available…one for the esophagus is another. BD

From the Website:

Patients typically begin fasting at midnight the day before the PillCam SB procedure.

The following morning when you arrive at your doctor’s office, a nurse or technician will explain the procedure to you. The nurse or technician will then fit you with the PillCam sensor belt, a comfortable belt worn around your waist and over your clothing. The PillCam recorder, a small portable recording device that communicates with the PillCam SB capsule as it passes through the small bowel, is attached to the sensor belt.

You will then be asked to swallow the vitamin-sized capsule with a glass of water and you will then be able to resume most daily activities.

You will be scheduled to return to the physician’s office with the sensor belt and the recorder.

Your physician will then download images from the recorder for review.

PillCam SB passes naturally with a bowel movement, usually in 24 to 72 hours.

YOQNEAM, ISRAEL, [February 3, 2014] -- Given Imaging Ltd, (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that the U.S. Food and Drug Administration (FDA) has cleared PillCam COLON as a new modality to provide visualization of the colon.

It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation and a complete evaluation of the colon was not technically possible. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

As previously announced at Digestive Disease Week in May 2013, Given Imaging conducted an 884-patient, 16-site clinical trial studying the accuracy and safety of PillCam COLON 2 compared to optical colonoscopy in detecting adenomas 6 millimeters or larger. Results from this clinical trial demonstrated that the sensitivity for PillCam COLON was 88% and specificity was 82% in detecting adenomas at least 6 millimeters in size.^{^[1]} The FDA based its clearance decision on an analysis of this clinical trial data that used a more restrictive methodology for matching polyps. In this analysis, which was conducted on hyperplastic polyps and adenomas, the positive percent agreement for PillCam COLON and optical colonoscopy was 69% and negative percent agreement was 81% for polyps at least 6 millimeters in size.^{^[2]}

http://www.givenimaging.com/en-us/Innovative-Solutions/Capsule-Endoscopy/pillcam-colon/Pages/COLON-Press-release.aspx