FDA Clearance for Crospon EsoFLIP® Dilation Catheter

Irish MIS device company Crospon tells us it has received US FDA clearance for its EsoFLIP® balloon dilation catheter. The device is complementary to the Crospon’s EndoFLIP® measurement device and represents the company’s first foray into endoscopic therapeutic products.

Background

EsoFLIP is the first product the in what Crospon says will be a suite of dilation catheter products to be used for dilation procedures in the esophagus and colon. It represents the company’s first foray into the therapeutic endoscopy accessory market and shipments are expected to commence in November 2013.

Company comments 

Commenting on the FDA clearance, John O’Dea, CEO, Crospon said, “This product marks our 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. We believe this product can be a game changer in balloon dilation. A unique 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. This will be particularly advantageous for pediatric patients. Equally, from an occupational safety standpoint, staff who perform many of these procedures each day, will no longer be required to be exposed to radiation. 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”.

Source: Crospon Ltd., Business Wire