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Product approval

Crospon’s EndoFLIP system cleared in the US

Approval is Crospon's first cleared application for gastroenterology
EndoFlip Monitor

Crospon has received FDA clearance for the first use of its EndoFLIP system in gastroenterology applications. 

The approved Barostat software option extends the FDA cleared uses for the EndoFLIP system to include pressure and dimension measurements taken in the oesophagus and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with oesophageal sensory hypersensitivity.

Previously, the EndoFlip was used to take measurement during gastric band and sleeve gastrectomy bariatric surgery procedures. All new EndoFLIP systems will include the Barostat software option.

“This clearance is important for Crospon as it, for the first time, allows us to market the EndoFLIP system in the US for gastroenterology applications,” said John O’Dea, CEO of Crospon. “Not only is this the company’s first cleared application for gastroenterology, but it also represents the first reimbursed application for the product”.

EndoFLIP 

The EndoFLIP (Endoluminal Functional Lumen Imaging Probe) Imaging System is used to measure the dimensions and function of hollow organs and sphincteric regions throughout the gastrointestinal tract These measurements are useful for different types of patients such as bariatric surgery patients, gastroesophageal reflux disease (GERD patients and potential candidates for GERD surgery.

The system injects a conductive solution into a balloon catheter placed in the measurement area. The balloon contains an array of electrodes that measure voltage and the system uses these voltages to estimate the diameter at up to 16 points along the measurement area. The EnoFLIP System allows snapshots of this data to be saved and commented for reference.

Example of a sleeve being created by gastric imbrications

The system allows a surgeon to set a consistent band stoma diameter at surgery for every patient. Consistent stoma size minimizes the risk of the band being too tight at the completion of surgery, and allows a surgeon to assess if sufficient peri-gastric fat has been removed to create an adequate stoma size. The system permits a surgeon to assess stoma size for patients where previous band-fill history is not available.

Endoflip after the gastric band has been adjusted

The EndoFLIP catheter may be deployed into a stoma to measure its diameter, both to allow the assessment of whether stoma repair is required, or to assess whether a stoma has been sufficiently reduced in size to effect an adequate repair. This is particularly useful where endoluminal repair of the stoma is being undertaken, since the stoma may be distended and measured before additional plications are made.

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