Ireland-based Crospon has obtained an approval from the US Food and Drug Administration for its EsoFLIP balloon dilation catheter.
The device allows measurements of lumen diameter to be made electrically and it eliminates the patient’s exposure to radiation during dilation procedures.
This will be particularly beneficial for pediatric patients.
EsoFLIP balloon dilation catheter also eliminates the need for staff, which performs many of the dilation procedures every day, to be exposed to radiation during the dilation procedures.
In addition, if a stent is required, these precise measurements assist gastroenterologists, for the first time, in selecting the stent size without the need for radiology.
Crospon CEO John O’Dea noted the EsoFLIP balloon dilation catheter marks the company’s entry into an adjacent, significant, established and reimbursed market segment.
"Whereas up to now our EndoFLIP product has been primarily used as a measurement device to provide guidance during surgical procedures, EsoFLIP represents our first therapeutic product, one which will be used during endoscopy," O’Dea added.
Crospon will launch the product in October 2013 at the American College of Gastroenterology 2013 annual scientific meeting in San Diego.
The company anticipates starting first shipments of the EsoFLIP catheter in November 2013.