FDA Deflates Sales, Imports of Dutch Endorectal Balloons
The FDA moved to block the importation and sale of a Dutch device designed to immobilize the prostate during radiation treatments to target it more accurately and minimize damage to surrounding tissue.
QLRAD Netherlands, maker of the RectalPro Endorectal Balloon, did not apply for the required premarket approval or investigational device exemption for the balloon, the FDA said in a warning letter.
QLRAD promoted the device for use with radiation therapy on its web site and in brochures distributed at medical conferences in San Antonio and Boston, the FDA said.
FDA regulations include an exemption from the approval requirements for manual, generic devices used in gastroenterology-urology surgery, but the RectalPro balloon does not qualify for the exemption because it is used for a different purpose, the FDA said.