Ireland-based manufacturer Crospon has announced that the US Food and Drug Administration has approved its EsoFLIP balloon dilation catheter.
According to the company, this is the first product from a suite of dilation catheter products to be used for dilation procedures in the esophagus and colon.
The device allows measurements of lumen diameter to be made electrically, eliminating the patient's exposure to radiation during dilation procedures.
By using the EsoFLIP balloon dilation catheter, the paediatric patients can be safeguarded from harmful radiation effects.
In addition, staff who perform many of the dilation procedures on a daily basis can stay safe from radiation exposure during the dilation procedures by using this device.
If a stent is required, these precise measurements assist gastroenterologists, for the first time, in selecting the stent size without the need for radiology.
The EsoFLIP provides integrated measurements of balloon diameter, allowing clinicians to determine when full balloon effacement has been achieved, without the use of fluoroscopy.
Crospon CEO John O'Dea said the EsoFLIP balloon dilation catheter marks the company's entry into an adjacent, significant, established and reimbursed market segment.
"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 said.
In September 2013, Crospon completed first human cases using EsoFLIP dilation technology on patients being treated for achalasia at University Medical Center, Utrecht, The Netherlands.
Crospon will launch the product in October 2013 at the American College of Gastroenterology 2013 annual scientific meeting in San Diego.
The company expects first shipments of the EsoFLIP catheter to start in November 2013.
Image: Comparison of standard fluoroscopic image (left) and EsoFLIP image with diameter measurements (right). Photo: courtesy of Crospon.