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FDA Approves Crospon’s EsoFLIP Balloon Dilation Catheter

First shipments of device to start next month.

The U.S. Food and Drug Administration has approved Crospon’s EsoFLIP balloon dilation catheter.

According to the Irish company, the EsoFLIP 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.

The EsoFLIP balloon dilation catheter protects pediatric patients undergoing dilation procedures from the effects of radiation as well as the staff who perform these procedures, the company claims.

The EsoFLIP provides integrated measurements of balloon diameter, allowing clinicians to determine when full balloon effacement has been achieved, without the use of fluoroscopy. The device also helps gastroenterologists choose the correct stent size without the need for radiology.

“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,” Crospon CEO John O’Dea said. “An advantage of EsoFLIP dilation catheter versus competitive products lies in the fact that it eliminates the need for patients to be exposed to radiation during dilation procedures, since the balloon allows measurements of lumen diameter to be made electrically. Furthermore if a stent is required, these precise measurements assist gastroenterologists, for the first time, in selecting the stent size without the need for radiology.”

Last month, Crospon completed first human cases using EsoFLIP dilation technology on patients being treated for achalasia at University Medical Center, Utrecht, The Netherlands.

Crospon is launching the product this week at the American College of Gastroenterology 2013 annual scientific meeting in San Diego, Calif.

The company expects first shipments of the EsoFLIP catheter to start next month.

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