Authors: Julian Fazi, Nova Szoka MD
Medtronic received FDA approval for CytospongeTM Cell Collection Device on August 16, 2018.
The CytospongeTM Cell Collection Device provides a minimally invasive method of sampling surface esophageal cells without the use of sedation in patients who require screening or surveillance of esophageal pathologies such as Barrett’s Esophagus (BE). This non-sterile, single use device consists of a 30mm compressed spherical sponge within a clear, vegetable-based capsule attached to a retainer card by a silicone braided polyester suture. The patient swallows the CytospongeTM and waits for capsule to dissolve in the stomach, where the sponge will release and expand. The CytospongeTM collects and samples the surface esophageal cells as it is retrieved from the stomach using the suture.
A prospective cohort study showed CytospongeTM with Trefoil factor 3 (TF-3) staining had a sensitivity and specificity of 73.3% and 93.8% for diagnosing BE >1 cm circumferential length compared with gastroscopy. When the length was >2 cm, the sensitivity and specificity increased to 90 and 93.5% respectively. A separate study showed that by using the CytospongeTM , it is possible to stratify patients with BE into low, moderate, and high risk of progression using an algorithm that includes patient characteristics, biomarker expression, length of BE segment, and presence of glandular atypia. Patients who are low risk may be spared from undergoing more invasive biopsy.
The FDA has determined this device to be substantially equivalent to predicate CytospongeTM Cell Collection Devices. Performance testing and functional testing consisting of compression testing, diameter measurement, laceration testing, dissolution, and tensile strength showed equivalence with predicate devices. The differences between the devices are that the current device is non-sterile, it has a thicker suture diameter, and a different sponge porosity.
This device is indicated for collection and sampling of surface esophageal cells for cytological and histological evaluation.
This device is contraindicated in patients experiencing dysphagia, swallowing disorders, anatomical abnormalities of esophagus or stomach, a history of gastric or esophageal dilation, ablation, or biopsy, a mucosal resection or invasive procedure within the past two months, portal hypertension/esophageal varices, pregnancy, and patients taking anticoagulants.
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